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Background: Repeated infection with C trachomatis increases the risk for serious sequelae: pelvic inflammatory disease, ectopic pregnancy, infertility, and chronic pelvic pain. A substantial proportion of women treated for C trachomatis infection are reinfected by an untreated male sex partner in the first several months after treatment. Effective strategies to ensure partner treatment are needed., Goal: The goal of the study was to determine whether repeated infections with C trachomatis can be reduced by giving women doses of azithromycin to deliver to male sex partners., Study Design: A multicenter randomized controlled trial was conducted among 1,787 women aged 14 to 34 years with uncomplicated C trachomatis genital infection diagnosed at family planning, adolescent, sexually transmitted disease, and primary care clinics or emergency or other hospital departments in five US cities. Women treated for infection were randomized to one of two groups: patient-delivered partner treatment (in which they were given a dose of azithromycin to deliver to each sex partner) or self-referral (in which they were asked to refer their sex partners for treatment). The main outcome measure was C trachomatis DNA detected by urine ligase chain reaction (LCR) or polymerase chain reaction (PCR) by 4 months after treatment., Results: The characteristics of study participants enrolled in each arm were similar except for a small difference in the age distribution. Risk of reinfection was 20% lower among women in the patient-delivered partner treatment arm (87/728; 12%) than among those in the self-referral arm (106/726; 15%); however, this difference was not statistically significant (odds ratio, 0.80; 95% confidence interval, 0.62-1.05; = 0.102). Women in the patient-delivered partner treatment arm reported high compliance with the intervention (82%)., Conclusion: Patient-delivered partner treatment for prevention of repeated infection among women is comparable to self-referral and may be an appropriate option for some patients.

Background: Nucleic acid-amplified tests for Chlamydia trachomatis are accurate but costly. Screening strategies for asymptomatic men are needed., Goal: To assess C trachomatis screening strategies for asymptomatic males., Study Design: Men attending a sexually transmitted disease clinic were tested for C trachomatis with ligase chain reaction and culture, and for urethral inflammation with urine leukocyte esterase and urethral Gram stain., Results: C trachomatis prevalence was 5.5% among 1,625 asymptomatic men. Ligase chain reaction increased detection by 49% among men without urethral inflammation. An age of younger than 25 years and urethral inflammation were associated with positive ligase chain reaction results. The negative predictive value of urine leukocyte esterase was highest among older men, but urethral Gram stain was equally sensitive in predicting infection regardless of age. An age of younger than 30 years or urethral inflammation identified the highest proportion of infections (92%) and reduced the percentage of men screened by 43%., Conclusions: Urine ligase chain reaction increased C trachomatis detection, particularly among men without urethral inflammation. Testing all asymptomatic men younger than 30 years is optimal, whereas negative urine leukocyte esterase or urethral Gram stain results in men 30 years or older support no testing.

Background: Sequelae of genital Chlamydia trachomatis infection in women are more strongly linked to repeat infections than to initial ones, and persistent or subsequent infections foster continued transmission., Objective: To identify factors associated with persistent and recurrent chlamydial infection in young women that might influence prevention strategies., Methods: Teenage and young adult women with uncomplicated C trachomatis infection attending reproductive health, sexually transmitted disease, and adolescent medicine clinics in five US cities were recruited to a cohort study. Persistent or recurrent chlamydial infection was detected by ligase chain reaction (LCR) testing of urine 1 month and 4 months after treatment., Results: Among 1,194 women treated for chlamydial infection, 792 (66.4%) returned for the first follow-up visit, 50 (6.3 %) of whom had positive LCR results. At that visit, women who resumed sex since treatment were more likely to have chlamydial infection (relative risk [RR], 2.0; 95% CI, 1.03-3.9), as were those who did not complete treatment (RR, 3.4; 95% CI, 1.6-7.3). Among women who tested negative for C trachomatis at the first follow-up visit, 36 (7.1%) of 505 had positive results by LCR at the second follow-up visit. Reinfection at this visit was not clearly associated with having a new sex partner or other sexual behavior risks; new infection was likely due to resumption of sex with untreated partners. Overall, 13.4% of women had persistent infection or became reinfected after a median of 4.3 months, a rate of 33 infections per 1,000 person months., Conclusions: Persistent or recurrent infection is very common in young women with chlamydial infection. Improved strategies are needed to assure treatment of women's male sex partners. Rescreening, or retesting of women for chlamydial infection a few months after treatment, also is recommended as a routine chlamydia prevention strategy.

Objectives: This study sought to define, among sexually transmitted disease (STD) clinic attendees, (1) patterns of sex partner selection, (2) relative risks for gonococcal or chlamydial infection associated with each mixing pattern, and (3) selected links and potential and actual bridge populations., Methods: Mixing matrices were computed based on characteristics of the study participants and their partners. Risk of infection was determined in study participants with various types of partners, and odds ratios were used to estimate relative risk of infection for discordant vs concordant partnerships., Results: Partnerships discordant in terms of race/ethnicity, age, education, and number of partners were associated with significant risk for gonorrhea and chlamydial infection. In low-prevalence subpopulations, within-subpopulation mixing was associated with chlamydial infection, and direct links with high-prevalence subpopulations were associated with gonorrhea., Conclusions: Mixing patterns influence the risk of specific infections, and they should be included in risk assessments for individuals and in the design of screening, health education, and partner notification strategies for populations.

Background: Urine tests for Chlamydia trachomatis permit expansion of screening beyond traditional clinic environments. Prevention of infection in teenagers is a high priority., Objective: To define the prevalence of C. trachomatis among teenagers by using the ligase chain reaction assay on urine specimens and to evaluate leukocyte esterase testing of urine specimens as an indicator of infection., Design: Cross-sectional study., Setting: An adolescent clinic, a juvenile detention facility, seven school-based clinics, and three community-based youth organizations in Seattle, Washington., Participants: 10,118 sexually active teenagers and young adults., Measurements: Chlamydia trachomatis infection detected in urine specimens by ligase chain reaction assay and leukocyturia detected by leukocyte esterase testing., Results: The prevalence of chlamydial infection among female participants was 8.6% and declined with increasing age; among male participants, it was 5.4% and increased with increasing age. In female participants, independent predictors of infection were being 17 years of age or younger (odds ratio [OR], 1.49), having had two or more sex partners in the previous 2 months (OR, 1.61), and having genitourinary symptoms (OR, 1.46). In male participants, independent predictors were being of nonwhite race or ethnicity (OR, 2.00 to 3.08), having had two or more sex partners in the previous 2 months (OR, 1.57), and having used a condom during the most recent sexual encounter (OR, 0.67). For identifying infection in male participants, the sensitivity of leukocyte esterase testing was 58.9%, the specificity was 94.9%, the positive predictive value was 38.4%, and the negative predictive value was 97.7%., Conclusions: Chlamydial infection is common in teenagers and young adults in community settings. The urine ligase chain reaction assay will permit widespread screening for C. trachomatis, but leukocyte esterase testing had low sensitivity for selecting persons for screening with this assay. Indicators of chlamydial infection differed substantially in male and female participants.

Selective screening has been associated with marked declines in the prevalence of chlamydial infection, the most common bacterial sexually transmitted disease (STD) in the United States. A comparison of the performance of different selective screening criteria in three groups of family planning and STD clinic clients shows that criteria recommended by the Centers for Disease Control and Prevention performed well overall, detecting 88-89% of infections by screening 58-74% of women. Criteria based on age alone performed best among low-risk clients with a low prevalence of chlamydial infection, particularly when all women younger than age 25 were screened (sensitivity, 84-92%); the age-based criteria still required screening only 59-71% of all women. Selective screening criteria should be based on age, risk profile and chlamydia prevalence in specific clinical settings, and should be reevaluated as chlamydia prevalence declines.

Background and Objectives: Detection of subclinical Chlamydia trachomatis infection in women is a high but costly public health priority., Goals: To develop and test simple selective screening criteria for chlamydia in women, to assess the contribution of cervicitis to screening criteria, and to evaluate cost-effectiveness of selective versus universal screening., Study Design: Cross-sectional study and cost-effectiveness analysis of 11,141 family planning (FP) and 19,884 sexually transmitted diseases (STD) female clients in Washington, Oregon, Alaska, and Idaho who were universally tested for chlamydia using cell culture, direct fluorescent antibody, enzyme immunoassay, or DNA probe., Results: Prevalence of cervical chlamydial infection was 6.6%. Age younger than 20 years, signs of cervicitis, and report of new sex partner, two or more partners, or symptomatic partner were independent predictors of infection. Selective screening criteria consisting of age 20 years or younger or any partner-related risk detected 74% of infections in FP clients and 94% in STD clients, and required testing 53% of FP and 77% of STD clients. Including cervicitis in the screening criteria did not substantially improve their performance. Universal screening was more cost-effective than selective screening at chlamydia prevalences greater than 3.1% in FP clients and greater than 7% in STD clients., Conclusions: Age and behavioral history are as sensitive in predicting chlamydial infection as criteria that include cervicitis. Cost-effectiveness of selective screening is strongly influenced by the criteria's sensitivity in predicting infection, which was significantly higher in STD clients. At the chlamydia prevalences in the populations studied, it would be cost saving to screen universally in FP clinics and selectively in STD clinics, the reverse of current practice in many locales.

This guideline addresses clinical trials of new antimicrobial agents in the treatment of uncomplicated genital infections caused by Chlamydia trachomatis and of syndromes resembling chlamydial infections. The most common clinical manifestations of chlamydial infection are urethritis in men and mucopurulent cervicitis in women. However, many chlamydial infections are not associated with inflammatory symptoms or signs. Culture is the diagnostic standard for defining the presence of C. trachomatis, although nonculture tests may be used in screening patients for enrollment in clinical trials. Susceptibility testing for C. trachomatis is laborious and difficult to standardize; only a few clinical isolates need to be tested in vitro. Prospective, randomized, double-blind, active-control comparative studies are recommended. Eradication of C. trachomatis defines both microbiological success and overall cure for chlamydial infection, but clinical and nonmicrobiological laboratory criteria are paramount in assessing the therapeutic response in nonchlamydial urethritis or cervicitis.

Endocervical infections due to Chlamydia trachomatis remain difficult to diagnose due to the lack of an inexpensive, rapid, and accurate test. We evaluated an alternative strategy for diagnosis in which initial screening was performed with an enzyme immunoassay (Chlamydiazyme) followed by a direct fluorescent antibody (DFA) test on specimens in which the Chlamydiazyme optical density (OD) reading fell in an intermediate zone. Lowering the Chlamydiazme OD ratio (specimen to control) used to define a positive test from 1.0 (the ratio suggested by the manufacturer) to 0.3 raised the sensitivity of Chlamydiazyme from 73 to 83%. Confirmation of those specimens having OD ratios of 0.3 to 0.99 by DFA testing increased the specificity of Chlamydiazyme from 95 to 100%. This strategy necessitated performance of the DFA test on 5% of the specimens. Lowering the cutoff OD ratio below 0.3 increased the sensitivity even further but required DFA testing on greater than 25% of the specimens. Use of an adjusted positive cutoff value for defining positive enzyme immunoassays followed by DFA confirmation for intermediate-zone readings may be a feasible approach for some laboratories that lack cell culture facilities.

To simplify the diagnosis of chlamydial genital infection, we used a fluorescein-conjugated monoclonal antibody in immunofluorescence tests on smears prepared from urethral or cervical secretions obtained directly from patients. This direct test, requiring less than 30 minutes to perform, was based on the detection of extracellular chlamydial elementary bodies. A comparison of the direct test with cultures stained with iodine on specimens from 926 patients demonstrated a sensitivity of 93 per cent and a specificity of 96 per cent. The direct test provides a rapid, simple, and sensitive method for the diagnosis of chlamydial infection, which can be performed in laboratories that do not have tissue-culture capability.

Background: Asymptomatic Chlamydia trachomatis (chlamydia) and Neisseria gonorrhoeae (gonorrhea) infections pose diagnostic and control problems in developing countries.Methods: Participants in China, India, Peru, Russia, and Zimbabwe were screened for C. trachomatis and N. gonorrhoeae infections and symptoms.Results: A total of 18,014 participants were evaluated at baseline, 15,054 at 12 months, and 14,243 at 24 months. The incidence of chlamydia in men was 2.0 per 100 person years both from baseline to 12 months and from 12 to 24 months, and in women, 4.6 from baseline to 12 months and 3.6 from 12 to 24 months; a range of 31.2% to 100% reported no symptoms across the 5 countries. The incidence of gonorrhea in men was 0.3 per 100 person years both from baseline to 12 months and from 12 to 24 months, and in women, 1.4 from baseline to 12 months and 1.1 from 12 to 24 months; a range of 66.7% to 100% reported no symptoms. Being female, aged 18 to 24 years, and having more than 1 partner were associated with both the infections. In addition, being divorced, separated, or widowed was associated with gonorrhea. Being male, having 6+ years of education, and reporting only 1 partner were associated with having no symptoms among those infected with chlamydia. No variables correlated with asymptomatic gonorrhea among those infected.Conclusion: A high prevalence and incidence of asymptomatic sexually transmitted infections was identified among men and women in a wide variety of settings. More effective programs are needed to identify and treat chlamydia and gonorrhea infections, especially among women, young adults, those with multiple partners, those repeatedly infected, and particularly those at risk without symptoms. The risk of transmission from persons with no symptoms requires further study. [ABSTRACT FROM AUTHOR]