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Background
Chlamydia infections are most commonly thought of as sexually transmitted diseases. Indeed, chlamydia represents a major public health concern causing venereal urethritis. In areas outside the United States, however, there are other serotypes of chlamydia that may cause trachoma, a leading cause of global blindness. Still, there are other species that can cause a mild to severe pneumonia, particularly among bird fanciers.
OUTLINE
DISEASE ASSOCIATIONS CHARACTERIZATION AORTIC ANEURYSM
Molecular detection and seroepidemiology of the Chlamydia pneumoniae bacteriophage (PhiCpn1).Karunakaran KP, Blanchard JF, Raudonikiene A, Shen C, Murdin AD, Brunham RC.
University of British Columbia Centre for Disease Control, Vancouver, Canada.
J Clin Microbiol 2002 Nov;40(11):4010-4 Abstract quote Recent whole-genome analysis has demonstrated limited genetic variation in Chlamydia pneumoniae, with one strain (AR39) containing a 4,524 nucleotide single-stranded DNA bacteriophage, PhiCpn1. Using PCR, reverse transcription (RT)-PCR, and Western blotting, we confirmed the presence and functional expression of PhiCpn1 in C. pneumoniae strain AR39 and its absence in strain CWL029. Six additional epidemiologically distinct clinical isolates of C. pneumoniae also did not contain PhiCpn1.
We generated recombinant viral protein 1 (Vp1) from PhiCpn1 in Escherichia coli and showed that Vp1 antigen is highly immunogenic in mice and that murine antisera readily recognize native Vp1 from C. pneumoniae strain AR39 elementary bodies (EB). We developed an enzyme-linked immunosorbent assay (ELISA) to measure antibodies to recombinant Vp1 in human sera collected from 32 patients with abdominal aortic aneurysm (AAA) and 40 controls. Among the 72 subjects, 61 had C. pneumoniae EB antibodies shown by ELISA. Antibodies to Vp1 were found in 39 of the 61 (64%) seropositive individuals and were significantly correlated with AAA (adjusted odds ratio, 13.9; 95% confidence interval, 1.1 to 175).
Our studies indicate that phage-containing strains of C. pneumoniae are uncommonly found by isolation but may commonly infect individuals with vascular disease.
Lack of association between serum immunoreactivity and Chlamydia pneumoniae detection in the human aortic wall.Porqueddu M, Spirito R, Parolari A, Zanobini M, Pompilio G, Polvani G, Alamanni F, Stangalini D, Tremoli E, Biglioli P.
Centro Cardiologico, Monzino Foundation, IRCCS, Department of Cardiovascular Surgery, University of Milan, Italy.
Circulation 2002 Nov 19;106(21):2647-8 Abstract quote BACKGROUND: Only a few studies have focused the attention on the relation between elevated anti-Chlamydia pneumoniae (CP) antibodies and the detection of CP in the arterial wall. The aim of our study is thus to investigate the relationship between immune response to CP and detection of CP in the aortic walls of patients with abdominal aortic aneurysm.
METHODS AND RESULTS: A specimen of aortic wall was obtained from 102 consecutive patients who underwent abdominal aneurysm repair. The possible presence of CP was studied by polymerase chain reaction and confirmed by nonradioactive DNA hybridization. Antibody response to CP was studied (IgG, IgA titers). We found 33 patients (32.4%) with CP DNA+. No correlation between CP DNA detection and antibody titers was found (IgG P=0.52, IgA P=0.66). High correlation between IgG and IgA titer was observed (P<0.01). Endovascular presence of CP and antibody titers was not related to the age of the patient.
CONCLUSIONS: CP antibody titers are not associated with the presence of CP in the aortic wall of patients with abdominal aortic aneurysm.
CERVICAL CANCER
A population-based prospective study of Chlamydia trachomatis infection and cervical carcinoma.Wallin KL, Wiklund F, Luostarinen T, Angstrom T, Anttila T, Bergman F, Hallmans G, Ikaheimo I, Koskela P, Lehtinen M, Stendahl U, Paavonen J, Dillner J.
Department of Molecular Medicine, Karolinska Institute, Stockholm, Sweden.
Int J Cancer 2002 Oct 1;101(4):371-4 Abstract quote Persistent human papillomavirus (HPV) infection is an established cause of cervical cancer, but the role of other sexually transmitted agents, most notably Chlamydia trachomatis, has not been well defined.
The women participating in the population-based cervical cancer screening program in Vasterbotten county of Northern Sweden were followed up for up to 26 years to identify 118 women who developed cervical cancer after having had a normal Pap smear (on average 5.6 years later; range 0.5 months-26 years). As controls, we selected another 118 women who were matched by birth cohort, time-point of sampling of the baseline normal smear and who had a normal smear at the time when the corresponding case was diagnosed with cancer. The Pap smears and cervical cancer biopsies were analyzed by PCR for C. trachomatis DNA and for HPV DNA.
At baseline, C. trachomatis DNA was present in 8% of cases but not among any one of the controls. The relative risk for cervical cancer associated with past C. trachomatis infection, adjusted for concomitant HPV DNA positivity, was 17.1 (95% CI 2.6-infinity).The presence of C. trachomatis and of HPV were not interrelated. Whereas C. trachomatis was primarily found in specimens taken many years before cancer diagnosis, HPV DNA was associated with a short lag time before cancer diagnosis.
Whereas most women who were HPV DNA-positive in the prediagnostic smear were also positive for the same virus in the cervical cancer biopsy, none of the women were positive for C. trachomatis in both the prediagnostic smear and in the subsequent cervical cancer.
In conclusion, a prior cervical C. trachomatis infection was associated with an increased risk for development of invasive cervical cancer.
GONORRHEA
Co-infection with gonorrhoea and chlamydia: how much is there and what does it mean?Creighton S, Tenant-Flowers M, Taylor CB, Miller R, Low N.
MRC Health Service Research Collaboration, Department of Social Medicine, University of Bristol, Canynge Hall, Whiteladies Road, Bristol BS8 2PR, UK.
Int J STD AIDS 2003 Feb;14(2):109-13 Abstract quote A cross-sectional study of new clients with either gonorrhoea or chlamydia attending King's College Hospital in 1998. One thousand two hundred and thirty-nine women and 1141 men had gonorrhoea, chlamydia or both. Overall, 24.2% (124/512) of heterosexual men and 38.5% (136/353) of women with gonorrhoea also had chlamydia (P<0.001).
Of heterosexual males 18.8% (124/660) and 13% (136/1022) of females with chlamydia also had gonorrhoea (P=0.002). Ethnicity had no effect on the proportion of co-infection after controlling for age and gender. Clients with dual infection were younger than those with either infection alone (P=0.0001). Over half of women and a quarter of men aged 15 to 19 years were dually infected so testing for both gonorrhoea and chlamydia may be appropriate in this age group in settings outside genitourinary clinics.
The high proportion of cases of gonorrhoea that also have chlamydia justifies the policy of epidemiological treatment for chlamydia.
LUNG DISEASE
Chlamydia pneumoniae infection and its role in asthma and chronic obstructive pulmonary disease.Clementsen P, Permin H, Norn S.
Department of Pulmonary Medicine, Gentofte University Hospital, Hellerup, Denmark.
J Investig Allergol Clin Immunol 2002;12(2):73-9 Abstract quote Chlamydia pneumoniae (CP) is a common cause of respiratory tract infections, and several studies have asked whether it may play a pathogenic role in connection with bronchial asthma and chronic obstructive pulmonary disease (COPD). Evidence that CP infection is associated with these diseases is a cardinal item. However, evaluation of CP infection is hampered by difficulties in obtaining agreement on the definition of a gold standard. In the literature, serology is based on different cutoff points of antibody titres, which complicates the definition of CP seropositive findings and the classification of acute infection, chronic and past infection.
In connection with acute and chronic infection, it is important to demonstrate the presence of CP by culture or polymerase chain reaction (PCR) in the respiratory tract, especially in the lower airways. Often, the results of serology is not associated with the findings by culture or PCR testing, which may involve the risk of inconclusive evidence.
Evaluation of a possible presence of CP by clinical improvement after treatment with antibiotics is difficult since uncontrolled studies have been used and other microorganisms are also affected by antibiotics. Furthermore, many patients improve without antibiotics, and improvement has also been observed in patients remaining culture positive after treatment with antibiotics. It should also be noted that the antiinflammatory effects of antibiotics may improve the clinical status of patients. Despite these obstacles, studies point to the possibility that in some patients acute CP infections may lead to acute exacerbations of bronchial asthma. Whether a persistent CP infection contributes to chronic asthma or severe COPD, or whether it incites the diseases in previously healthy individuals is a question for further studies.
Whether a causal relationship exists between CP infection and obstructive pulmonary disease or whether these patients are more susceptible to CP infection is unknown. Nevertheless, a cooperative role of CP in the proinflammatory mechanisms involved in these diseases remains to be examined since cellular studies show that CP stimulates the production and expression of cytokines, chemokines and adhesion molecules, actions that may amplify and prolong the inflammation.
REITER'S SYNDROME Triad of conjunctivitis, polyarthritis, and genital infection
Associated with C. trachomatis infection
PATHOGENESIS CHARACTERIZATION Obligate intracellular bacteria Humans are only known host for all strains of T. trachomatis
Contain both DNA and RNA
Cannot replicate outside cells or synthesize ATPElementary body is dense, spherical from 0.2-0.4 um with prokaryotic ribosomal RNA with rigid cell wall-this is the infectious form and capable of limited extracellular survival
Reticulate body is intracellular metabolically active form, incapable of surviving outside of the cells, ranging from 0.6-1.0 um
Outer membranes composed of the major outer membrane protein (MOMP) and a lipopolysaccharide layer (LPS)
Infection Organism attaches to columnar epithelial cells via the elementary body
It localizes within indentations of the plasma membrane and enters the cell via an endosome
Endosomes containing elementary bodies of C. psittaci do not fuse with cellular lysosomes whereas those containing C. trachomatis do fuse with one another and with other lysosomes
Six to eight hours after entry into the host cell, the elementary bodies changes to the reticulate body and replication begins
Reticulate bodies reorganize withing 18-24 hours after infection, mature into elementary bodies, and are released from the host cell
CHARACTERIZATION Evaluation of Urine Specimen Integrity in a Public Health STD Screening Program
Nathan C. Birch, MD
Douglas F. Stickle, PhD
Anita Young
Philip Medina
and Steven H. Hinrichs, MDAm J Clin Pathol 2003;119:516-521 Abstract quote
Detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae infection in urine using molecular amplification assays has permitted institutions with limited medical facilities to offer testing for these sexually transmitted diseases (STDs).The Nebraska Public Health Laboratory (NPHL) investigated the validity of urine samples submitted for C trachomatis and/or N gonorrhoeae amplification after receiving a substantial number of clear specimens. Approximately 75% of all urine specimens submitted for STD testing to the NPHL were from correctional facilities. The falsification of urine specimens submitted for microbiology studies is not evaluated routinely, and this problem was previously undocumented.
By using the criteria for specific gravity of 1.001 or less and a creatinine concentration of less than 5 mg/dL (442 µmol/L), approximately 8% of all specimens submitted during the study interval were determined to be inconsistent with urine. The microbiology laboratory should be aware of the possibility for specimen manipulation to identify facilities submitting falsified specimens, to initiate appropriate intervention, and to minimize false-negative reporting.
Evaluation of self-collected samples in contrast to practitioner-collected samples for detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis by polymerase chain reaction among women living in remote areas.Knox J, Tabrizi SN, Miller P, Petoumenos K, Law M, Chen S, Garland SM.
Sexual Health Unit of Territory Health Services, Alice Springs, Northern Territory, Australia.
Sex Transm Dis 2002 Nov;29(11):647-54 Abstract quote BACKGROUND: Self-collected samples have been shown to be an acceptable and sensitive method for the detection by polymerase chain reaction (PCR) of sexually transmitted infections (STIs) among women.GOAL The goal of the study was to compare self-collected sampling methods to conventional practitioner endocervical sampling for the PCR detection of and and to compare two self-collected sampling methods for the detection of by PCR.
STUDY DESIGN: Women (n = 318) from urban and remote areas of central Australia participated in the study when attending their health clinic for a check-up. They each provided a FVU sample, self-collected vaginal swab specimen, and tampon specimen. This was followed by a clinical examination by a practitioner, with collection of endocervical and high vaginal swabs for testing by conventional microscopy and culture for and, respectively. The FVU, self-collected vaginal swab, tampon, and endocervical swab specimens were tested by Roche Cobas Amplicor for and. The self-collected vaginal swab and tampon specimens were also tested by an in-house PCR method for the detection of T vaginalis.
RESULTS: In toto, was detected by PCR in 11.5%, in 11.8%, and in 24.6%. Molecular diagnostics for and were significantly more sensitive than traditional assays with microscopy and culture. For the detection of by PCR, tampons were the most sensitive (100.0%) and urine the least sensitive (72.7%) specimens ( = 0.01). For the detection of by PCR, the self-collected tampon was the most sensitive specimen, followed by the endocervical swab, self-collected swab, and urine specimen, with sensitivities of 97.2%, 92.6%, 71.9%, and 31.2%, respectively. For detection of, statistically significant differences were detected for urine versus tampon ( < 0.0001), endocervical swab ( < 0.001), and self-collected swab ( = 0.01) and for self-collected swab versus tampon ( = 0.01). Subsequent data collection showed that sensitivity of urine PCR for detection of improved with freezing of urine specimens and shorter transport time. Tampons were also more sensitive than self-collected swabs for detection of (sensitivity of 100% versus 87.7%).
CONCLUSION: Self-collected specimens offer women in remote communities an acceptable and sensitive alternative method of testing for STIs. The low sensitivity of PCR of urine specimens may reflect poor transport and storage conditions, which we have shown can be improved by freezing urine specimens and reducing transport delays.
CULTURE Culture in McCoy cells-current reference method for C. trachomatis DNA HYBRIDIZATION AND NUCLEIC ACID SIGNAL AMPLIFICATION DIGENE HYBRID CAPTURE
Comparison of Digene Hybrid Capture 2 and Conventional Culture for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Cervical Specimens.Darwin LH, Cullen AP, Arthur PM, Long CD, Smith KR, Girdner JL, Hook III EW, Quinn TC, Lorincz AT.
Digene Corporation, Gaithersburg, Maryland 20878. University of Alabama at Birmingham, Birmingham, Alabama 35294. Johns Hopkins University, Baltimore, Maryland 21205.
J Clin Microbiol 2002 Feb;40(2):641-4 Abstract quote Digene's Hybrid Capture 2 (HC2) CT/GC, CT-ID, and GC-ID DNA tests were evaluated by comparison to traditional culture methods for detecting Chlamydia trachomatis and Neisseria gonorrhoeae infections in 669 cervical specimens from high-risk female populations attending two sexually transmitted disease clinics.
For detection of either or both infections, the HC2 CT/GC test algorithm had 93.8% sensitivity and 95.9% specificity compared to those of culture. After resolution of discrepant results by direct fluorescent-antibody (DFA) staining or PCR assay, the relative sensitivity and specificity of the HC2 CT/GC test algorithm increased to 94.8 and 99.8%, while the values for culture were 83.6% (McNemar's P value, 0.0062) and 100%, respectively.
For detection of the individual pathogens, the relative sensitivities for the HC2 CT-ID and GC-ID tests were 97.2 and 92.2% and the specificities were greater than 99% compared to culture adjucated by DFA staining and PCR. Test performance varied at the two clinics: the HC2 CT/GC algorithm, CT-ID, and GC-ID tests had significantly higher sensitivities (McNemar's P value, <0.05) than that of culture for the population at one clinic as well as for the combined populations. At the other clinic, the HC2 tests performed as well as culture.
Evaluation of the Hybrid Capture 2 CT/GC DNA tests and the GenProbe PACE 2 tests from the same male urethral swab specimens.Darwin LH, Cullen AP, Crowe SR, Modarress KJ, Willis DE, Payne WJ.
Digene Corporation, Gaithersburg, Maryland 20878, USA.
Sex Transm Dis 2002 Oct;29(10):576-80 Abstract quote BACKGROUND: A previous study demonstrated that Digene's Hybrid Capture 2 (HC2) DNA tests for detection of and (CT/GC) could be performed using cervical swab specimens collected in GenProbe transport media with significantly greater sensitivity for the detection of than with the GenProbe PACE 2 system. GOAL: The goal was to assess the performance of HC2 tests in comparison with GenProbe PACE 2 tests for the detection of CT/GC in male urethral swab specimens.
STUDY DESIGN: A total of 1,202 male urethral swab specimens were collected in GenProbe PACE transport medium. All specimens were first tested with the PACE 2 system, followed by masked HC2 CT/GC testing. The GenProbe AMPLIFIED CT Assay (AMP CT) and PCR/SHARP Signal System (SHARP) were used for adjudication of discrepant results.
RESULTS: The prevalence rates for this population were 8.4% for and 14.6% for, based on the adjudicated results. The relative sensitivity and specificity for the detection of were 97.0% and 99.8% for HC2 and 69.3% and 98.3% for PACE 2, respectively. The relative sensitivities for the detection of were 98.9% for HC2 and 99.4% for PACE 2, with the same specificity of 99.9% for both tests. Agreement between the two testing methods was 95.4% for and 99.6% for.
CONCLUSION: The HC2 test is compatible with the GenProbe collection medium, with significantly greater sensitivity than the GenProbe PACE 2 test for detecting and similar sensitivities for detecting.
Evaluation of the digene hybrid capture II CT-ID test for detection of Chlamydia trachomatis in endocervical specimens.Girdner JL, Cullen AP, Salama TG, He L, Lorincz A, Quinn TC.
Division of Infectious Diseases, The Johns Hopkins University, Baltimore, Maryland 21205, USA.
J Clin Microbiol 1999 May;37(5):1579-81 Abstract quote The performance characteristics of the new signal amplification-based Hybrid Capture (HC) II CT-ID test system (Digene, Silver Spring, Md.) with endocervical specimens were compared to those of tissue culture and PCR (AMPLICOR CT PCR; Roche Molecular Systems, Branchburg, N.J.) for detection of Chlamydia trachomatis in 587 women. HC II CT-ID identified 62 of 65 confirmed C. trachomatis-positive patients (sensitivity of 95.4%) and was negative for 517 of 522 patients who were negative by culture and PCR (specificity of 99.0%).
Twelve of the 65 confirmed positive patients were negative by culture but were identified by both HC II CT-ID and PCR (sensitivity of culture was 81.5% [P < 0.01]). In comparison, PCR detected 59 of 65 positive specimens (sensitivity of 90.8%) and had a specificity of 99.6% (520 of 522).
These results demonstrate that the Digene HC II CT-ID test is a highly sensitive and specific assay for the detection of C. trachomatis infection in endocervical specimens.
Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in swab specimens by the Hybrid Capture II and PACE 2 nucleic acid probe tests.Modarress KJ, Cullen AP, Jaffurs WJ Sr, Troutman GL, Mousavi N, Hubbard RA, Henderson S, Lorincz AT.
Digene Corporation, Silver Spring, Maryland 20904, USA.
Sex Transm Dis 1999 May;26(5):303-8 Abstract quote BACKGROUND AND OBJECTIVES: The Digene Hybrid Capture II (HC II) CT/GC Test (Digene Corp., Beltsville, MD) is a new nucleic acid signal amplification-based test for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in specimens from the genital tract. For optimal results, the HC II CT/GC Test employs a special conical shaped brush for cervical specimen collection from nonpregnant women and swabs from pregnant women. GOALS: To validate a protocol for HC II C. trachomatis and N. gonorrhoeae testing of specimens collected for the GenProbe PACE 2 System.
STUDY DESIGN: Specimens were collected from 1,746 patients with a swab and placed in GenProbe transport media according to the manufacturer's recommended procedure. The specimens were first tested at two clinical laboratories by the PACE 2 system, and then blindly tested by HC II CT/GC using an adjusted cutoff value. Discrepant specimens were adjudicated by polymerase chain reaction (PCR), and the result common to two of the three testing methods (HC II, PACE 2, and PCR) was defined as the consensus result.
RESULTS: Combining the data from both sites, the relative sensitivity of the HC II Test compared with the consensus result for the detection of 1,761 specimens for C. trachomatis and 1,750 specimens for N. gonorrhoeae was 100% for both organisms. The relative specificities for C. trachomatis and N. gonorrhoeae detection were 99.8% and 99.7%, respectively. The relative sensitivities of the PACE 2 CT and GC Systems were 86.5% and 87.1%, respectively, with relative specificities of 99.9% and 100%. The difference in sensitivity between HC II and PACE 2 for C. trachomatis detection was significant (P < 0.016).
CONCLUSION: The HC II CT/GC Test can be performed using specimens collected in GenProbe transport media and has a significantly greater sensitivity for C. trachomatis detection than the PACE 2 System.
Ability of the digene hybrid capture II test to identify Chlamydia trachomatis and Neisseria gonorrhoeae in cervical specimens.Schachter J, Hook EW 3rd, McCormack WM, Quinn TC, Chernesky M, Chong S, Girdner JI, Dixon PB, DeMeo L, Williams E, Cullen A, Lorincz A.
Chlamydia Research Laboratory, Department of Laboratory Medicine, University of California, San Francisco, San Francisco, California 94110, USA.
J Clin Microbiol 1999 Nov;37(11):3668-71 Abstract quote The Digene Hybrid Capture II (HCII CT/GC) test is a combination test designed to detect Chlamydia trachomatis and Neisseria gonorrhoeae in a single specimen. It is a nucleic acid hybridization test which uses signal amplification to increase sensitivity.
We compared its performance to that of culture on cervical specimens from 1,370 women. Direct fluorescent-antibody assay was used to resolve discrepant results for C. trachomatis. Samples were collected with a proprietary cervical brush or with endocervical swabs. The HCII CT/GC test proved to be sensitive and specific in detecting these organisms.
Compared to N. gonorrhoeae culture, it had a sensitivity of 93% (87/94) and a specificity of 98.5% (1,244/1,263). Compared to C. trachomatis culture, the sensitivity was 97.7% (129/132) and specificity was 98.2% (1,216/1,238). Testing of some specimens with discrepant results by PCR suggested that the test would actually prove to be even more specific if it were compared to a nucleic acid amplification test (NAAT). The sensitivity of C. trachomatis culture was somewhat less, at 88.6% (117/132). The endocervical brush appeared to be better than Dacron swabs for collecting specimens. The HCII CT/GC test offers an attractive format that allows simultaneous detection of C. trachomatis and N. gonorrhoeae with a single specimen. An initial positive result is followed by repeat tests with probes to identify chlamydiae or gonococci.
This test is more sensitive than C. trachomatis culture and is at least as sensitive as culture for gonococci. It deserves further evaluation and comparison with NAATs and may well offer an attractive alternative for diagnosis and screening of these infections.
ABBOT LCX
Evaluation of the Abbott LCx ligase chain reaction assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine and genital swab specimens from a sexually transmitted disease clinic population.Carroll KC, Aldeen WE, Morrison M, Anderson R, Lee D, Mottice S.
Department of Pathology, University of Utah Health Sciences Center, Salt Lake City 84132, USA.
J Clin Microbiol 1998 Jun;36(6):1630-3 Abstract quote The Abbott LCx ligase chain reaction (LCR) assay for the simultaneous detection of Chlamydia trachomatis and Neisseria gonorrhoeae was evaluated by using swab and urine specimens from 562 patients. C. trachomatis results by LCR were compared to those by the Gen-Probe PACE 2 assay, whereas N. gonorrhoeae results by LCR were compared to those by culture. The Gen-Probe and LCR assays were performed according to the manufacturers' instructions. Gram-negative diplococci growing on modified Thayer-Martin medium were confirmed as N. gonorrhoeae by the GonoGen II assay. Supplemental data analysis was performed by major outer membrane protein PCR for C. trachomatis and probes for pilin gene detection for N. gonorrhoeae. A true-positive result for each pathogen was defined as a positive result for all three or two of three assays.
Overall agreement among the six assays was 94.8%. C. trachomatis prevalence was 16.2%; N. gonorrhoeae prevalence was 5.5%. The overall sensitivity and specificity, respectively, for each test (after supplemental data analysis) were as follows: for C. trachomatis, Gen-Probe, 65.9 and 100%; LCR on urine, 90.1 and 100%; LCR on swab specimens, 96.7 and 100%; and for N. gonorrhoeae, culture, 80.6 and 100%; LCR on urine, 93.5 and 99.8%; and LCR on swab specimens, 96.8 and 100%. For women, the N. gonorrhoeae culture was very insensitive compared to its performance in men (58.3 versus 94.7%, respectively).
For C. trachomatis, the Gen-Probe assay's sensitivity was lower for men than for women (62.3 versus 71.1%, respectively). The sensitivity for C. trachomatis detection by LCR on urethral and cervical swab specimens was 96.2 and 97.4% for men and women, respectively. For men, swab results were slightly better than urine results for both pathogens (sensitivity for C. trachomatis in swab and urine specimens, 96.2 and 92.5%, respectively; sensitivity for N. gonorrhoeae in swab and urine specimens, 100 and 94.7%, respectively), while for women, cervical swabs were superior in sensitivity to urine samples for detecting C. trachomatis (swab, 97.4%; urine, 81.6%) and equivalent for N. gonorrhoeae (swab, 92.3%; urine, 91.6%). The LCx LCR appears to be both sensitive and specific for the detection of C. trachomatis and N. gonorrhoeae when performed on urine or genital swab samples. Swab samples had better sensitivity than urine samples for the detection of both pathogens.
BD PROBETEC
Strand displacement amplification and homogeneous real-time detection incorporated in a second-generation DNA probe system, BDProbeTecET.Little MC, Andrews J, Moore R, Bustos S, Jones L, Embres C, Durmowicz G, Harris J, Berger D, Yanson K, Rostkowski C, Yursis D, Price J, Fort T, Walters A, Collis M, Llorin O, Wood J, Failing F, O'Keefe C, Scrivens B, Pope B, Hansen T, Marino K, Williams K, et al.
Becton Dickinson Microbiology Systems, 54 Loveton Circle, Sparks, MD 21152, USA.
Clin Chem 1999 Jun;45(6 Pt 1):777-84 Abstract quote BACKGROUND: Amplified DNA probes provide powerful tools for the detection of infectious diseases, cancer, and genetic diseases. Commercially available amplification systems suffer from low throughput and require decontamination schemes, significant hands-on time, and specially trained laboratory staff. Our objective was to develop a DNA probe system to overcome these limitations.
METHODS: We developed a DNA probe system, the BDProbeTecTMET, based on simultaneous strand displacement amplification and real-time fluorescence detection. The system uses sealed microwells to minimize the release of amplicons to the environment. To avoid the need for specially trained labor, the system uses a simple workflow with predispensed reagent devices; a programmable, expandable-spacing pipettor; and the 96-microwell format. Amplification and detection time was 1 h, with potential throughput up to 564 patient results per shift. We tested 122 total patient specimens obtained from a family practice clinic with the BD ProbeTecET and the Abbott LCx(R) amplified system for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae.
Results: Based on reportable results, the BDProbeTecET results for both organisms were 100% sensitive and 100% specific relative to the LCx.
Conclusions: The BDProbeTecET is an easy-to-use, high-throughput, closed amplification system for the detection of nucleic acid from C. trachomatis and N. gonorrhoeae and other organisms.
Performance characteristics of the Becton Dickinson ProbeTec System for direct detection of Chlamydia trachomatis and Neisseria gonorrhoeae in male and female urine specimens in comparison with the Roche Cobas System.Chan EL, Brandt K, Olienus K, Antonishyn N, Horsman GB.
Virology Section, Department of Clinical Microbiology, Provincial Laboratory, Regina, Saskatchewan, Canada.
Arch Pathol Lab Med 2000 Nov;124(11):1649-52 Abstract quote OBJECTIVE: The Becton Dickinson BDProbeTec ET System is a new semiautomated system using strand displacement amplification technology that simultaneously amplifies and detects Chlamydia trachomatis and Neisseria gonorrhoeae DNA. The strand displacement amplification products are hybridized with a fluorescent detector probe and are captured by a chemiluminescent assay in a microwell format. An amplification control is also included to monitor assay inhibition. This study evaluated the performance of the BDProbTec ET system in detecting C trachomatis and N gonorrhoeae in male and female urine specimens, calculated its ability to process large volumes of specimens, and determined the inhibition rate.
MATERIALS AND METHODS: Eight hundred twenty-five male and 399 female urine specimens were tested for both C trachomatis and N gonorrhoeae with the BDProbeTec ET system, and results were compared with those of the Roche Amplicor Cobas system. All urine specimens were processed on both assays on the same day they were received, according to the manufacturers' instructions. Discrepant results were resolved by in-house polymerase chain reaction assays. Internal or amplification controls were also used in each specimen assay to monitor inhibition. The throughput of the BDProbTec ET system was further tested with 150 urine specimens on an 8-hour shift for 2 days.
RESULTS: The overall sensitivity, specificity, positive predicative value, and negative predicative value for for detection of chlamydia were 95.3%, 99.3%, 95.9%, and 99.2% for strand displacement amplification and 95.9%, 98.3%, 90.6%, and 99.3% for the Roche Amplicor system. For detection of gonorrhea, these values were 100%, 99.7%, 88.2%, and 100% and 96.7%, 98.9%, 69%, and 99.9%, respectively. The overall inhibition rates for both strand displacement amplification and Roche Amplicor were less than 3.5%. The BDProbTec ET system was able to produce 150 results each for chlamydia and gonorrhea and the internal control within the 8-hour shift.
CONCLUSIONS: The performance characteristics of the BDProbeTec ET assay are similar to those of the Roche Amplicor polymerase chain reaction for detection of chlamydia and gonorrhea in male and female urine specimens. The system was able to produce 300 results in an 8-hour shift.
Multicenter evaluation of the BDProbeTec ET System for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens, female endocervical swabs, and male urethral swabs.Van Der Pol B, Ferrero DV, Buck-Barrington L, Hook E 3rd, Lenderman C, Quinn T, Gaydos CA, Lovchik J, Schachter J, Moncada J, Hall G, Tuohy MJ, Jones RB.
Indiana University School of Medicine, Indianapolis, IN 46202, USA.
J Clin Microbiol 2001 Mar;39(3):1008-16 Abstract quote The performance of the Becton Dickinson BDProbe Tec ET System Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays (BD Biosciences, Sparks, Md.) was evaluated in a multicenter study.
Specimens were collected from 2,109 men and women, with or without symptoms, attending sexually transmitted disease, family planning, and obstetrics and gynecology clinics. Both swab and urine samples were collected, and the results obtained from 4,131 specimens were compared to those from culture and the LCx nucleic acid amplification test (Abbott Industries, Abbott Park, Ill.). PCR and cytospin of the culture transport medium with chlamydia direct fluorescent antibody staining were used to adjudicate chlamydia culture-negative results. Sensitivity and specificity were calculated both with and without use of the amplification control (AC), with little apparent difference in the results. Without the AC result, sensitivity for C. trachomatis and N. gonorrhoeae were 92.8 and 96.6%, respectively, for cervical swabs and 80.5 and 84.9% for urine from women. C. trachomatis and N. gonorrhoeae sensitivities were 92.5 and 98.5%, respectively, for male urethral swabs and 93.1 and 97.9% for urine from men.
This amplified DNA system for simultaneous detection of chlamydial and gonococcal infections demonstrated superior sensitivity compared to chlamydia culture and has performance characteristics comparable to those of other commercially available nucleic acid-based assays for these organisms.
Screening for Chlamydia trachomatis infection using the BDProbeTec ET Chlamydia trachomatis amplified DNA assay on urine in a GUM clinic setting: a simple, fast and cost-effective alternative.Browning MR, Corden S, Mitchell B, Westmoreland D.
Department of Genitourinary Medicine, West Wing Hospital (Cardiff Royal Infirmary), Newport Road, Cardiff CF24 0SZ, UK.
Int J STD AIDS 2001 Jul;12(7):430-6 Abstract quote This study compared the BDProbeTec ET Chlamydia trachomatis amplified DNA assay on urine specimens with culture of genital swabs for the detection of C. trachomatis in patients attending the Department of Genitourinary Medicine (GUM), Cardiff Royal Infirmary. Almost twice as many patients tested positive by BDProbeTec ET than by culture.
A similar difference was found for both males and females. The case notes of those patients positive by BDProbeTec ET alone were analysed and a significantly greater number were found to have risk indicators for C. trachomatis infection when compared with age and sex comparable controls, providing clinical validation of our findings. The BDProbeTec ET assay was easy to use, more importantly, the test format features an internal control integral with every sample. The cost per true positive was calculated as comparable with culture.
We conclude that the BDProbeTec ET assay is a superior alternative to culture for identifying patients infected with C. trachomatis in the GUM clinic setting.
Evaluation of a strand displacement amplification assay (BD ProbeTec-SDA) for detection of Neisseria gonorrhoeae in urine specimens.Akduman D, Ehret JM, Messina K, Ragsdale S, Judson FN.
Denver Public Health Department, Denver, Colorado 80204-4507, USA.
J Clin Microbiol 2002 Jan;40(1):281-3 Abstract quote The performance of a strand displacement amplification assay (the BDProbeTec-SDA assay) in detecting Neisseria gonorrhoeae in urine specimens was evaluated.
When performed under stringent quality control conditions, the BDProbeTec-SDA assay is a sensitive, specific, and efficient method for the screening of large numbers of noninvasively obtained specimens.
Because the predictive value of an assay is a function of the prevalence of the disease, culture confirmation is needed for samples with positive results from populations in which the prevalence of a disease is low or in situations in which false-positive results may have important medical, psychosocial, or medicolegal consequences.
COBAS AMPLIACOR
Evaluation of COBAS AMPLICOR (Roche): accuracy in detection of Chlamydia trachomatis and Neisseria gonorrhoeae by coamplification of endocervical specimens.Livengood CH 3rd, Wrenn JW.
Chlamydia Laboratory, Duke University Medical Center, Durham, North Carolina, USA.
J Clin Microbiol 2001 Aug;39(8):2928-32 Abstract quote We evaluated further the accuracy of the COBAS AMPLICOR (Roche) (CA) PCR-based system in detection of Chlamydia trachomatis and Neisseria gonorrhoeae in endocervical specimens. Endocervical specimens collected for any indication for testing for C. trachomatis and N. gonorrhoeae among a university hospital health system population were included.
Testing for C. trachomatis was done by two PCR methods, CA and manual microwell AMPLICOR (Roche) (MWA), and by culture; testing for N. gonorrhoeae was done by CA and culture. Discrepancy resolution was performed. Reproducibility testing and hands-on labor time measurements for CA were done. Among 654 C. trachomatis samples, the prevalence of true positivity was 9.2%, and among the 618 N. gonorrhoeae samples, the prevalence of true positivity was 4.4%. For detection of C. trachomatis, the sensitivity, specificity, and negative and positive predictive values were, respectively, as follows for each test: CA, 93.3, 99.7, 99.3, and 96.4%; MWA, 91.7, 99.7, 99.2, and 96.5%; and culture, 65.0, 100, 96.6, and 100%. For detection of N. gonorrhoeae those values were as follows: CA, 96.3, 100, 99.8, and 100%; and culture, 92.6, 100, 99.7, and 100%. Hands-on labor time for each clinical result was estimated to be at 7.5 min. The prevalence of inhibitory specimens was 3.5%, including two positive C. trachomatis samples which would have been missed otherwise. The direct cost of each clinical result with CA was estimated to be $9.09.
Our methods include a diverse range of indications for testing among women, using endocervical swabbing samples, 2 M sucrose phosphate transport medium, and discrepancy resolution for comparison. Under our test conditions, the CA system is an accurate, rapid, and cost- and labor-efficient method for detection of C. trachomatis and N. gonorrhoeae.
GEN PROBE
A comparative study for detection of Chlamydia trachomatis and Neisseria gonorrhoeae with DNA probe (a note).Szell A, Tisza T, Horvath A.
Department of Dermato-Venereology, Semmelweis University School of Medicine, Budapest, Hungary.
Acta Microbiol Immunol Hung 1994;41(3):291-3 Abstract quote A newly developed DNA probe assay (Gen-Probe Pace 2 San Diego, USA) was compared with Chlamydia trachomatis direct immunofluorescence and Neisseria gonorrhoeae culture. Detection of C. trachomatis in cervical specimens from women and urethral specimens from men showed 23% positivity out of 313 cases.
Out of the 69 positive cases 40 were positive with both examinations, in 29 cases only with DNA probe. Examinations of N. gonorrhoeae in 254 patients gave 98% positivity. Sensitivity of DNA probe assay was 100%, specificity was 97.8%.
On the basis of preliminary data Gen-Probe is suitable for the detection of both causative agents.
Evaluation of nucleic acid-based test (PACE 2C) for simultaneous detection of Chlamydia trachomatis and Neisseria gonorrhoeae in endocervical specimens.Iwen PC, Walker RA, Warren KL, Kelly DM, Hinrichs SH, Linder J.
Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, USA.
J Clin Microbiol 1995 Oct;33(10):2587-91 Abstract quote A nucleic acid-based test (Gen-Probe PACE 2C System) was evaluated for the ability to detect Chlamydia trachomatis and Neisseria gonorrhoeae from endocervical specimens in a single assay.
Three swab samples, randomized for collection order, were obtained from each patient and tested by N. gonorrhoeae and C. trachomatis culture and by the PACE 2C probe assay. Fifty of 395 specimens were culture positive for N. gonorrhoeae (17 specimens), C. trachomatis (26 specimens), or both (7 specimens), of which PACE 2C testing detected 48 specimens. The PACE 2C assay was positive for 56 specimens, including 8 specimens not positive by culture. Of the total of 10 discrepancies between culture and PACE 2C results, resolution testing yielded four false-negative culture, four false-positive PACE 2C, and two false-negative PACE 2C results. The sensitivity, specificity, and positive and negative predictive values for PACE 2C after reevaluation were 96.3, 98.8, 92.9 and 99.4%, respectively. The overall sensitivities for C. trachomatis and N. gonorrhoeae culture were 89.2 and 88.9%, respectively. The prevalence rate for C. trachomatis was 9.4%, and that for N. gonorrhoeae was 6.8%.
The Gen-Probe PACE 2C System is a reliable alternative for screening endocervical specimens for both C. trachomatis and N. gonorrhoeae in a single assay.
Performance of the Gen-Probe AMPLIFIED Chlamydia Trachomatis Assay in detecting Chlamydia trachomatis in endocervical and urine specimens from women and urethral and urine specimens from men attending sexually transmitted disease and family planning clinics.Ferrero DV, Meyers HN, Schultz DE, Willis SA.
San Joaquin County Regional Public Health Laboratory, Stockton, California, USA.
J Clin Microbiol 1998 Nov;36(11):3230-3 Abstract quote The Gen-Probe AMPLIFIED Chlamydia Trachomatis Assay (AMP CT) uses transcription-mediated amplification and hybridization protection assay procedures to qualitatively detect Chlamydia trachomatis rRNA in urine, endocervical swab, and urethral specimens.
The performance of the AMP CT was compared to that of cell culture for endocervical swab and urine specimens from women and urethral and urine specimens from men. Analysis of specimens with discrepant results was performed by a combination of reculture, direct fluorescent-antibody (DFA) staining of specimen sediment, and amplification which targeted a different chlamydial rRNA. A total of 800 urine samples were tested by the AMP CT (607 from women and 193 from men), and 7. 1% were positive for C. trachomatis, with a sensitivity of 91.2% and a specificity of 99.6% upon discrepant analysis. A total of 926 swab specimens were tested by culture and AMP CT (717 endocervical swab specimens and 209 urethral swab specimens from men), and 7.7% were positive for C. trachomatis, with a sensitivity and specificity of 100% upon discrepant analysis.
The AMP CT is a sensitive and specific nucleic acid hybridization assay for the detection of C. trachomatis in endocervical swab specimens from women, urethral swab specimens from men, and urine specimens from men and women.
GROSS APPEARANCE/
CLINICAL VARIANTSCHARACTERIZATION
SPECIES AND SEROTYPE DISEASES TRANSMISSION Chlamydophila psittaci (Chlamydia psittaci) Ornithosis (Psittacosis) Aspiration of bird contaminated particles Chlamydophila pneumoniae (Chlamydia pneumoniae) Mild pneumonia Aerosols (person to person) Chlamydia trachomatis Trachoma Repeated contact, fomites, insects Inclusion conjunctivitis
Nongonorrheal urethritis
Postgonorrheal urethritis
Proctitis, pharyngitis, cervicitis, arthritisBirth canal infection (infants)
Sexual contact, swimming (adults)
Sexual contact
Sexual contactLymphogranuloma venereum Sexual contact
PNEUMONIA Fatal hemorrhagic pneumonia concomitant with Chlamydia pneumoniae and parainfluenza virus 4 infection.
Rubinas TC, Carey RB, Kampert MC, Alkan S, Lednicky JA.
Department of Pathology, Loyola University Medical Center, Maywood, Ill 60153, USA.
Arch Pathol Lab Med. 2004 Jun;128(6):640-4. Abstract quote
CONTEXT: Cases of fatal hemorrhagic pneumonia need to be investigated for highly contagious viral causes. While not all hemorrhagic pneumonias are caused by very contagious agents, the etiology must be correctly determined in order to administer appropriate patient care.
OBJECTIVE: To determine whether chlamydia, paramyxovirus, or mycoplasma was the causative agent in a case of fatal hemorrhagic pneumonia, and to evaluate the possibility that this was the first case of hantavirus pulmonary syndrome in Illinois.
DESIGN: Nonroutine virological and molecular analyses were performed on lung tissue taken during an unrestricted autopsy of a patient who died in 2002.
SETTING AND PATIENT: An elderly, male, Chicago-area resident with a 3-week history of nonspecific, mild upper respiratory tract infection was admitted for hospital treatment of the respiratory infection and viral myositis without cardiac involvement. The patient became febrile, hypoxic, developed hemorrhagic pneumonia, and died. Because he had proven exposure to mice and had developed hemorrhagic pneumonia, hantavirus pulmonary syndrome was suspected as the cause of death. Mice known to carry hantaviruses live in Illinois, including the Chicago area.
INTERVENTIONS: Gatifloxacin and heparin anticoagulation were initiated because community-acquired pneumonia and pulmonary embolism were considered likely etiologies for an acute exacerbation of hypoxemia.
RESULTS: Two respiratory pathogens were isolated and identified: Chlamydia pneumoniae and human parainfluenza virus 4a.
CONCLUSIONS: A mixed (polymicrobial) infection contributed to the patient's death. Hemorrhage was likely a result of anticoagulation therapy superimposed on lung tissues damaged by pneumonia. The uncommon nature of this case and the pathogens involved underscore the challenges in infection control and clinical evaluation that hospitals will face when confronted with possibly new and potentially deadly communicable diseases.
Prevalence, rate of persistence and respiratory tract symptoms of Chlamydia pneumoniae infection in 1211 kindergarten and school age children.Schmidt SM, Muller CE, Mahner B, Wiersbitzky SK.
Department of Infectious, Bronchopulmorary and Allergic Deseases, Children's and Youth Hospital, Ernst-Moritz-Arndt University, Greifwald, Germany.
Pediatr Infect Dis J 2002 Aug;21(8):758-62 Abstract quote BACKGROUND: is a common cause of respiratory disease, but little is known about asymptomatic infection, duration of persistent respiratory tract infection and seasonal changes of prevalence in a normal large sample size pediatric population.
METHODS: We studied the prevalence of infection in 1211 children of 3 age groups: 3- to 4-year-old kindergarten children ( = 184) and schoolchildren attending first and second ( = 353) or seventh and eighth grade classes ( = 674). Polymerase chain reaction and enzyme immunoassay detection (PCR-EIA) of throat swabs were used. Respiratory tract symptoms (cough, rhinitis, earache or sore throat) were recorded in 1028 schoolchildren. Follow-up examinations in PCR-positive patients were performed until negative.
RESULTS: PCR was positive in 68 children (5.6%) without significant age and gender related differences in prevalence. Epidemics were confirmed with a prevalence up to 24% in a primary school in December and April. In schoolchildren, asymptomatic infection was a common feature, reaching 54% (32 of 59) of PCR-EIA positives. The rate of asymptomatic infection was 6% (32 of 531 schoolchildren without symptoms). Of the 32 asymptomatic PCR-EIA positives, 26 (81%) were children attending seventh and eighth grade classes. In 3 children PCR-EIA remained positive at 3 to 5 weeks and became negative during the next 7 to 9 weeks. One of 2 schoolchildren with persistent infection was asymptomatic.
CONCLUSIONS: We conclude that infection is common in the childhood population studied with seasonal variations in prevalence and epidemic-like occurrence. Asymptomatic infection occurs, especially in teenagers, but persistent infection is rare.
SPECIAL STAINS/
IMMUNOPEROXIDASE/
OTHERCHARACTERIZATION Direct immunofluorescence (DIF) Antibodies performed upon fresh tissue, directed against MOMP
PROGNOSIS AND TREATMENT CHARACTERIZATION PROGNOSTIC FACTORS SCREENING
Effect of a clinical practice improvement intervention on chlamydial screening among adolescent girls.Shafer MA, Tebb KP, Pantell RH, Wibbelsman CJ, Neuhaus JM, Tipton AC, Kunin SB, Ko TH, Schweppe DM, Bergman DA.
University of California, San Francisco, School of Medicine, Department of Pediatrics, Division of Adolescent Medicine, Box 0503, San Francisco, CA 94143-0503
JAMA 2002 Dec 11;288(22):2846-52 Abstract quote CONTEXT: Chlamydia trachomatis infection is a serious public health concern that disproportionately affects adolescent girls. Although annual C trachomatis screening of sexually active adolescent girls is recommended by health professional organizations and is a Health Employer Data and Information Set (HEDIS) performance measure, this goal is not being met.
OBJECTIVE: To test the effectiveness of a system-level, clinical practice improvement intervention designed to increase C trachomatis screening by using urine-based tests for sexually active adolescent girls identified during their routine checkups at a pediatric clinic.
DESIGN, SETTING, AND PARTICIPANTS: A randomized cluster of 10 pediatric clinics in the Kaiser Permanente of Northern California health maintenance organization, where adolescent girls aged 14 to 18 years had a total of 7920 routine checkup visits from April 2000 through March 2002.
INTERVENTION: Five clinics were randomly assigned to provide usual care and 5 to provide the intervention, which required that leadership be engaged by showing the gap between best practice and current practice; a team be assembled to champion the project; barriers be identified and solutions developed through monthly meetings; and progress be monitored with site-specific screening proportions.
MAIN OUTCOME MEASURE: Chlamydia trachomatis screening rate for sexually active 14- to 18-year-old girls during routine checkups at each participating clinic.
RESULTS: The population of adolescents was ethnically diverse with an average age of 15.4 years. Twenty-four percent of girls in the experimental clinics and 23% in the control clinics were sexually active. Of the 1017 patients eligible for screening in the intervention clinic, 478 (47%) were screened; of 1194 eligible for screening in the control clinic, 203 (17%) were screened. At baseline, the proportion screened was 0.05 (95% confidence interval [CI], 0.00-0.17) in the intervention and 0.14 (95% CI, 0.01-0.26) in the control clinics. By months 16 to 18, screening rates were 0.65 (95% CI, 0.53-0.77) in the intervention and 0.21 (95% CI, 0.09-0.33) in the control clinics (time period by study group interaction, F(6,60) = 5.33; P<.001). The average infection rate for the experimental clinics was 5.8% (23 positive test results out of 393 total urine tests and a total of 3986 clinic visits) vs 7.6% in controls (12 positive test results out of 157 tests and 3934 clinic visits).
CONCLUSIONS: Implementation of this clinical practice intervention in a large health maintenance organization system is feasible, and it significantly increased the C trachomatis screening rates for sexually active adolescent girls during routine checkups.
TREATMENT GENITAL INFECTIONS
Azithromycin versus doxycycline for genital chlamydial infections: a meta-analysis of randomized clinical trials.Lau CY, Qureshi AK.
Cedars Sinai Medical Center, Department of Internal Medicine, Los Angeles, California 90048, USA.
Sex Transm Dis 2002 Sep;29(9):497-502 Abstract quote BACKGROUND: Azithromycin and doxycycline are recommended for treatment of genital Chlamydia trachomatis infection. A systematic review comparing these antibiotics could affect treatment guidelines.
GOAL: The goal was to perform a meta-analysis to evaluate the efficacy and tolerance of azithromycin versus doxycycline for genital chlamydial infection.
STUDY DESIGN: Studies were identified by searching computerized English-language databases for the period 1975 to August 2001, supplemented by a manual bibliographic search. Criteria for inclusion were (1) randomized trial design; (2) regimens of oral doxycycline (100 mg twice daily for 7 days) and oral azithromycin (1 g once); (3) males >15 years of age and nonpregnant females >15 years of age; (4) and evaluation of microbial cure at follow-up. Data were extracted on diagnostic assay, follow-up time, study design, sponsorship, patients' characteristics, adverse events, attrition rates, and outcomes.
RESULTS: Twelve trials met the inclusion criteria; 1543 patients were evaluated for microbial cure and 2171 for adverse events. Cure rates were 97% for azithromycin and 98% for doxycycline. Adverse events occurred in 25% and 23% of patients treated with azithromycin and doxycycline, respectively. After pooling of the data, differences in efficacy and risk were computed. The efficacy difference for microbial cure (0.01; 95% CI, -0.01-0.02) and the risk difference for adverse events (0.01; 95% CI, -0.02-0.04) between the two drugs were not statistically significant.
CONCLUSION: Azithromycin and doxycycline are equally efficacious in achieving microbial cure and have similar tolerability. Further head-to-head trials comparing these antibiotics are unnecessary.
PREGNANCY
Treatment of genital Chlamydia trachomatis infection in pregnancy.Genc MR.
Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Harvard Medical School, Brigham & Women's Hospital, 75 Francis Street, Boston, MA 02115, USA
Best Pract Res Clin Obstet Gynaecol 2002 Dec;16(6):913-22 Abstract quote This chapter gives a systematic review of the literature on treatment of Chlamydia trachomatis infections in pregnant women.
The benefits of timely treatment of chlamydial infections in pregnant women are discussed. Antibiotic regimens commonly used for this purpose are identified. A meta-analysis based on randomized trials on pregnant women was performed to compare various antibiotic regimes in terms of microbiological cure, side-effects and tolerance. Data on safety related to the use of these antibiotics during pregnancy are summarized.
Cost-effectiveness analyses on relevant antibiotic regimes for the treatment of uncomplicated chlamydial infection in women are identified. Their relevance and their shortcomings regarding the obstetric population are discussed. Treatment options for those who failed initial antibiotic treatment, as well as for the sexual partners of infected patients, are mentioned.
PROSTATITIS
Comparative analysis of azithromycin and clarithromycin efficacy and tolerability in the treatment of chronic prostatitis caused by Chlamydia trachomatis.Skerk V, Schonwald S, Krhen I, Markovinovic L, Barsic B, Marekovic I, Roglic S, Zeljko Z, Vince A, Cajic V.
J Chemother 2002 Aug;14(4):384-9 Abstract quote A total of 123 patients, older than 18 years of age, with symptoms of chronic prostatitis and inflammatory findings as well as the presence of Chlamydia trachomatis confirmed by DNA/RNA DIGENE hybridization method in expressed prostatic secretion or in voided bladder urine collected immediately after prostatic massage, were examined. The patients were randomized to receive a total of 4.5 g of azithromycin for 3 weeks, given as a 3-day therapy of 1 x 500 mg weekly or clarithromycin 500 mg b.i.d. for 15 days. Patients' sexual partners were treated at the same time. Clinical and bacteriological efficacy were evaluated 4-6 weeks after the end of therapy. In the group of patients with chronic chlamydial prostatitis the eradication rates (azithromycin 37/46, clarithromycin 36/45) and the clinical cure rates (azithromycin 32/46, clarithromycin 32/45) were not significantly different with regards to the administered drug (p > 0.05). In the group of patients with asymptomatic chlamydial prostatitis the eradication rates (azithromycin 11/16, clarithromycin 10/15) were not significantly different with regards to the administered drug (p = 1.00, OR = 1.1).
Henry JB. Clinical Diagnosis and Management by Laboratory Methods. Twentieth Edition. WB Saunders. 2001.
Robbins Pathologic Basis of Disease. Sixth Edition. WB Saunders 1999.
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