Therapeutic trial and pharmacokinetics of sulbactam for uncomplicated gonorrhea in men.

The efficacy of intramuscular sulbactam for uncomplicated gonorrhea was assessed in 20 men infected with beta-lactamase-negative Neisseria gonorrhoeae. Ten subjects received 2.0 g of sulbactam given in a single intramuscular dose with 1.0 g of probenecid orally; 4 of 10 urethral infections persisted, as did one rectal infection. Ten subjects were treated with 0.5 g of intramuscular sulbactam given twice, 4 h apart; 3 of 10 urethral infections and 2 of 2 rectal infections persisted. The geometric mean MIC of sulbactam for 20 pretreatment isolates of N. gonorrhoeae was 1.37 microgram/ml (range, 0.25 to 8.0 micrograms/ml). Serum levels of sulbactam, determined for nine subjects in the two treatment groups, fell below the MIC of some gonococci after less than 6 h with both regimens. In the regimens studied, sulbactam alone is not suitable as therapy for uncomplicated gonorrhea. determined for nine subjects in the two treatment groups, fell below the MIC of some gonococci after less than 6 h with both regimens. In the regimens studied, sulbactam alone is not suitable as therapy for uncomplicated gonorrhea.

Diagnosis of mucopurulent cervicitis among women at risk for Chlamydia trachomatis infection.

The present study was undertaken to evaluate the utility of a gram stain of endocervical secretions in the prediction of endocervical infection with Chlamydia trachomatis. Endocervical examinations, Gram stains and chlamydial cultures were performed on 214 women who were attending a sexually transmitted diseases clinic and were at increased risk for chlamydial infection. Almost 24% of the Gram stains were judged inadequate because of the presence of ectocervical material. However, significantly higher isolation rates for C. trachomatis were found for those women with valid smears and 10 or more polymorphonuclear cells on their smear (44% vs 19%, P = .0008). This relationship was independent of the presence of gonococcal infection. Based on the results of this study, endocervical Gram stains appear to be a valuable screening tool for chlamydial infection, particularly among those without mucopurulent discharge.

Evaluation of field follow-up in a sexually transmitted disease clinic for patients at risk for infection with Neisseria gonorrhoeae and Chlamydia trachomatis.

Field follow-up to locate and treat partners of patients with syphilis and gonorrhea is standard procedure in the United States. The present study utilized 12,732 heterosexual index patients with gonococcal infection, chlamydial infection, and related syndromes to evaluate the effectiveness of field follow-up over a 6-year period. Field follow-up located 82% of the 13,845 partners identified by the index patients. Of those partners who were located, 36% had a documented infection with either chlamydia or gonorrhea. An average of only 1.09 partners per index patient was named, however, indicating that all partners may not have been reported. The largest number of infected partners was located for all index patients with gonorrhea and for men with chlamydia. Contact tracing was also effective for women with chlamydia, although less so. Field follow-up, as conducted in this study, is effective in locating the partners who are reported by the index patients.

Compliance with antibiotic therapy for Chlamydia trachomatis and Neisseria gonorrhoeae.

Control of bacterial sexually transmitted diseases (STD) depends on adequate antibiotic therapy. During a 4-week period, a survey concerning compliance was administered to all patients attending an STD clinic who were being treated with one of the standard antibiotic regimens for presumed gonococcal or chlamydial infections. Of the 497 eligible patients, 406 (81.7%) were surveyed between 24 hours and 72 hours after the end of treatment. Of those being treated with the standard 7-day regimen of tetracycline or erythromycin, 63.4% complied. Compliance was not associated with race, gender, symptoms, or antibiotic regimen. Those who were younger, were sexual contacts of an infected partner, or had gastrointestinal side effects were more likely not to comply with treatment.

A randomized trial to compare 7- and 21-day tetracycline regimens in the prevention of recurrence of infection with Chlamydia trachomatis.

Standard therapy for Chlamydia trachomatis in the United States consists of a 7-day course of tetracycline administration. Recurrent infections are frequent, however, in circumstances in which reinfection seems unlikely, suggesting that the standard regimen may be insufficient to cure the infection. It may reduce the number of organisms, however, below a detectable level at a test-of-cure visit. To evaluate recurrent infection, the authors studied patients with chlamydia who were treated with standard therapy, and they found a recurrence rate of 29% among 2,983 patients who returned to the clinic during a 2-year follow-up period. Recurrent infection was associated with younger age but was not related to either race or gender. To test the hypothesis that a longer treatment course might be more effective in preventing recurrent infection, the authors conducted a randomized trial that compared 7- and 21-day regimens of tetracycline administration. Of the 918 subjects enrolled in the trial, 220 were infected with C. trachomatis. The overall recurrence rate among patients who were infected and returned was 18.4% (9/49) in the 21-day group and 13.8% (8/58) in the 7-day group (P = .60). Similar results were obtained using survival analysis methods. Given the number of subjects who returned, this study had approximately a 65% statistical power to detect a reduction in recurrence rate, from 20% to 5%. Because of the similarity of the results in the two groups, it was concluded that 21 days of tetracycline administration is no more effective in preventing recurrence than 7 days of administration.

Behavioral intervention to increase condom use among high-risk female adolescents.

OBJECTIVE: To determine whether condom use among high-risk female adolescents could be increased by a behavioral intervention, with the use of infection with Chlamydia trachomatis as a biomarker of condom practices. DESIGN: Prospective, randomized, controlled intervention. SETTING: Urban family planning and sexually transmitted disease clinics. PARTICIPANTS: Two hundred nine female adolescents, aged 15 through 19 years, who were treated for C. trachomatis genitourinary infection, were randomly assigned to standard (control) or experimental (behavioral intervention) groups. One hundred twelve subjects returned for follow-up 5 to 7 months after enrollment and comprise the study subjects. MEASUREMENTS: Subjects completed a multiinstrument questionnaire measuring sexual behavior, condom practices, attitudes and beliefs, cognitive complexity, sociodemographics, and motivation at enrollment and follow-up. Endourethral and endocervical sites were sampled for C. trachomatis. RESULTS: Among the 112 subjects who returned for repeated examination, those who had received the experimental intervention reported increased use of condoms by their sexual partners for protection against sexually transmitted diseases (odds ratio = 2.4; p = 0.02) and for vaginal intercourse (odds ratio = 3.1; p = 0.005) at the 6-month follow-up. Multivariable logistic regression analysis controlling for condom use at enrollment demonstrated that the experimental intervention (odds ratio = 2.8; p = 0.03) and the higher cognitive complexity (odds ratio = 4.6; p = 0.02) independently contributed to greater condom use at follow-up. Despite greater use of condoms among the group who had received the intervention, use remained inconsistent and rates of reinfection with C. trachomatis were not significantly different (26% vs 17%; p = 0.3). CONCLUSION: Although a brief behavioral intervention among high-risk female adolescents can increase condom use by their sexual partners, incident infection does not appear to be reduced, because condom use remained inconsistent.

PIP: In Indianapolis, Indiana, health workers randomly assigned 209 female adolescents, 15-19 years old, all of whom were sexually active and had Chlamydia trachomatis infection, to either the standard education group or to the behavioral intervention group to determine whether a behavioral intervention could increase condom use among this high-risk group. Researchers used infection with C. trachomatis as a biomarker of condom practices. The standard intervention was an individual discussion with the clinic nurse about sexually transmitted diseases (STDs) (e.g., importance of partner treatment and condom use) using the normal clinic procedure and printed material on chlamydia infection. The behavioral intervention included a discussion of chlamydia infection using the printed pamphlet as a guide, demonstration of how to use a condom correctly using a plastic banana, encouragement to practice putting a condom on the proxy phallus during the visit, and providing skills to negotiate condom use with sexual partners. 54% (112) of the adolescents returned for follow-up 5-7 months after enrollment. Adolescents in the intervention group were much more likely to use condoms for protection against STDs at follow-up than at baseline (odds ratio [OR] = 2.4; p = 0.02) and for vaginal intercourse (OR = 3.1; p = 0.005). They were not more likely to use condoms during last intercourse, however. When the researchers controlled for the frequency of use of condoms for vaginal intercourse at enrollment, adolescents in the intervention group were significantly more likely to use condoms during vaginal intercourse at follow-up than at baseline (p = 0.01). The multivariable logistic regression revealed that the experimental intervention and higher cognitive complexity among some adolescents had an independent positive influence on condom use at follow-up (OR = 2.8, p = 0.03 and OR = 4.6, p = 0.02, respectively). Despite higher condom use rates in the intervention group, the rate of reinfection with C. trachomatis was not significantly different than the control group (26% vs. 17%; p = 0.3). In conclusion, the intervention did not achieve consistent condom use.

Interferon-gamma in endocervical secretions of women infected with Chlamydia trachomatis.

Although interferon-gamma has been associated with control of chlamydial infections in mice, no direct evidence links it to human chlamydial infections. Therefore, interferon-gamma was assayed by ELISA in endocervical secretions and plasma of women cultured for Chlamydia trachomatis. Women with positive endocervical chlamydial cultures had increased levels of interferon-gamma in endocervical secretions (6.7 +/- 2.8, mean +/- SE, n = 47) compared with uninfected women (1.4 +/- 0.4, n = 52) (P = .002). Interferon was also present in secretions of women with gonorrhea. Higher levels were seen in secretions from older women with positive chlamydial cultures. Interferon levels in secretions did not correlate with simultaneous plasma levels, the number of organisms recovered in tissue culture, or clinical correlates of inflammation. These data suggest that interferon-gamma is present at the site of chlamydial infection; however, further experiments are needed to determine whether interferon is specifically involved in protection or is a nonspecific indicator of inflammation.

Historical and clinical factors associated with Chlamydia trachomatis genitourinary infection in female adolescents.

Five hundred sixty-eight adolescent female patients receiving routine gynecologic care at urban clinics were screened by culture for Chlamydia trachomatis infection at both the urethra and endocervix. Culture results for 562 were available from either or both sites. Positive cultures were obtained from 139 (25%). Urethral infection was not associated with either urinary tract symptoms or sterile pyuria, but urethral or endocervical infection was associated with cervical friability (P = less than 0.0001), endocervical mucopus (P = 0.0001), cervical erythema (P = 0.0002), and cervical ectopy or erosion (P = 0.01). Increased chlamydial infection rates were associated with older age (P = 0.01), history of more frequent intercourse (P = 0.01), and history of more than one lifetime partner (P = 0.023), with a marginal association for being black (P = 0.05). Method of contraception, reason for attending clinic, age at menarche, age at first intercourse, years sexually active, number of sexual partners in preceding 6 months, parity, and prior history of sexually transmitted disease were not associated with having chlamydial genitourinary infection.

Efficacy of 250 mg trospectomycin sulfate i.m. vs. 250 mg ceftriaxone i.m. for treatment of uncomplicated gonorrhea.

BACKGROUND AND OBJECTIVES: Due to the steadily progressive development of resistance to the drugs used for treatment, Neisseria gonorrhoeae remains a medical concern. Trospectomycin sulfate is a 6' propyl analogue of spectinomycin with potent activity against penicillin sensitive and resistant strains of N. gonorrhoeae. GOAL OF THIS STUDY: To compare the efficacy of 250 mg trospectomycin sulfate i.m. versus 250 mg ceftriaxone i.m. for single dose therapy for men and women with uncomplicated gonorrhea. STUDY DESIGN: Dual-center, randomized comparative trial. RESULTS: Among evaluable male patients with urethral gonorrhea, 36 of 40 (90%, 95% confidence interval [95%CI] 76%-97%) who were treated with trospectomycin sulfate were cured, and 22 of 22 patients (100%, [85%-100%]) treated with ceftriaxone were cured. Among evaluable female patients with cervical gonorrhea all were cured following trospectomycin sulfate (23 of 23) and following ceftriaxone therapy (13 of 13). The cure rates for pharyngeal gonorrhea were 67% (8 of 12 patients, 35%-90%) for trospectomycin sulfate therapy, and 100% (2 of 2) with ceftriaxone therapy. CONCLUSIONS: Trospectomycin sulfate, 250 mg i.m., is effective, and well tolerated. However, for treatment of uncomplicated genital and pharyngeal gonorrhea, it is not as reliable for therapy as other recommended regimens.

Cytomegalovirus infection in sex partners: evidence for sexual transmission.

To examine the hypothesis that cytomegalovirus (CMV) is sexually transmitted, we determined the prevalences of antibody to CMV and viral shedding in 63 male sex partners of women with or without CMV infection, and CMV isolates from infected couples were compared by DNA restriction enzyme analysis. The prevalence of seropositivity by enzyme-linked immunosorbent assay was 31 (74%) of 42 men whose female partners were seropositive compared with five (31%) of 16 men whose partners were seronegative (P = .008). CMV was isolated from the semen or urine of four (22%) of 18 men whose female partners shed CMV from the cervix or urine compared with none of 42 whose partners were culture negative (P = .013). DNA restriction enzyme typing of CMV isolates from three pairs of sex partners showed that two of the couples were infected with common strains; epidemiologically unrelated isolates gave distinct patterns. Heterosexual contact is a major mode of transmission of CMV among some young adults.

Age and clinical immunity to infections with Chlamydia trachomatis.

BACKGROUND AND OBJECTIVES: The prevalence of chlamydial infection decreases with age possibly in part because of increasing immunity. GOAL OF THIS STUDY: To determine whether increased age is an independent predictor of decreased chlamydial infection and whether chlamydia-specific antibody titer and blastogenesis increase with age. STUDY DESIGN: Data from all patients cultured for Chlamydia trachomatis between January 1984 and August 1989 were examined and multiple logistic regression models were used to identify the independent predictors of culture positivity. Antichlamydial antibody titer and chlamydia-specific blastogenesis were examined for a subset of patients for correlation with age. RESULTS: Young age was found to be predictive of chlamydial infection independent of all factors examined in men and women. Antibody titers had no relation to age (n = 245) whereas the level of blastogenesis correlated only weakly with age (n = 155). CONCLUSIONS: Assays of systemic immunity do not reflect the protection from chlamydial infection associated with age.

Factors associated with condom use among sexually active female adolescents.

A health belief model of condom use was used to identify factors associated with condom use in 390 sexually active female adolescents, aged 12 through 19 years, recruited at the time of a visit for reproductive health care. Fifty-six percent were white and the remainder black. Nineteen percent had genitourinary infections with Chlamydia trachomatis. Forty-six percent reported having had more than one sexual partner in the preceding year. Reported condom use for at least one specific reason (prevention of pregnancy, sexually transmitted disease, or acquired immunodeficiency syndrome) increased as behavioral, emotional, and sexually transmitted disease risk decreased, and as cognitive maturity and positive condom attitudes increased. Although uses of condoms to prevent pregnancy, sexually transmitted disease, and acquired immunodeficiency syndrome were positively intercorrelated, each made a contribution to explaining condom use at most recent coitus (odds ratios 2.95, 3.96, and 2.81, respectively). After statistical adjustment for the reported reasons for previous condom use, behavioral risk was the only additional factor associated with condom use at the most recent sexual encounter; women who participated in more risk behaviors (substance and alcohol use and minor delinquency) were less likely to have used a condom (odds ratio 0.61). Knowledge about sexually transmitted disease and acquired immunodeficiency syndrome, and concurrent use of contraceptive pills, were not related to condom practices. The data suggest that adolescents' perceptions about condoms, including the individual functions of condoms for contraception and for prevention of sexually transmitted disease, may be important in determining their use. Engaging in unprotected intercourse may be part of a larger behavioral domain that includes other unhealthy behaviors.

Effect of blind passage and multiple sampling on recovery of Chlamydia trachomatis from urogenital specimens.

Detection of chlamydial infections depends on the sensitivity of the techniques used. Variables include the number of body sites sampled, the number of samples obtained, and the number of passages in tissue culture. To assess these factors, microdilution plate cultures with a single blind passage were performed on specimens from 10,291 men and women attending a sexually transmitted disease clinic. Overall, 21% of the men and 30% of the women were culture positive. However, 18% of endocervical, 28% of female urethral, and 29% of male urethral cultures that were positive became so only after a single passage. Of culture-positive women, 23% were positive at the urethra only. Pooled urethral and endocervical specimens were positive more often than an endocervical specimen alone but less often than separately cultured endocervical and urethral specimens. A total of 221 specimens from 92 men and 66 women were subjected to five serial blind passages. Of 83 positive specimens, 29 (35%) were positive only after two or more passages. A total of 37 (46%) women were culture-positive, but only 12 (33%) of those who were positive and had an endocervical culture would have been detected by a single endocervical culture that was not passaged. The sensitivity of chlamydial culture is substantially less than 100% but can be improved by culturing samples from both the urethra and endocervix in women and by serial passage in tissue culture.