Comparison of clindamycin phosphate vaginal cream with triple sulfonamide vaginal cream in the treatment of bacterial vaginosis.

BACKGROUND: Triple sulfonamide vaginal cream has been used to treat bacterial vaginosis for many years. There are few studies in which triple sulfonamide cream has been compared with newer regimens. GOAL: To compare the efficacy and safety of clindamycin phosphate vaginal cream with that of triple sulfonamide vaginal cream in the treatment of bacterial vaginosis. STUDY DESIGN: In this double-blind, randomized multicenter study, nonpregnant women 16 years of age or older with symptomatic bacterial vaginosis were assigned to receive either 2% clindamycin phosphate vaginal cream or triple sulfonamide vaginal cream for 7 days. Follow-up visits were conducted 5 to 10 days and 25 to 39 days after completion of treatment. RESULTS: Clinical cure or improvement at 25 to 39 days was noted in 55 (69.6%) of 79 assessable participants who received clindamycin vaginal cream and in 33 (41.8%) of 79 women who received triple sulfonamide vaginal cream (P < 0.0001). Most of the difference between the treatment groups was noted in women with a history of bacterial vaginosis. Among women without a history of bacterial vaginosis, clindamycin and triple sulfonamide creams had similar efficacy. Evaluation of Gram-stained vaginal smears correlated with clinical outcome. Most patients in both treatment groups reported an improvement in symptoms. No significant difference was observed between the treatment groups in the incidence of adverse events. CONCLUSION: Clindamycin 2% vaginal cream is more effective than triple sulfonamide vaginal cream in the treatment of bacterial vaginosis.

Susceptibility of isolates of Neisseria gonorrhoeae to penicillin and tetracycline in Brooklyn, 1988-1992.

BACKGROUND AND OBJECTIVES: The aim of this analysis was to determine the rate of resistance of Neisseria gonorrhoeae to penicillin and tetracycline over 5 years. STUDY DESIGN: The authors studied 500 isolates of N. gonorrhoeae. Minimum inhibitory concentrations of various antimicrobial agents, including penicillins, tetracyclines, quinolones, cephalosporins, spectinomycin, and trospectomycin, were determined using agar dilution. Organisms that produced beta-lactamase were classified as penicillinase-producing N. gonorrhoeae, and those with tetracycline minimum inhibitory concentrations > 16 micrograms/ml were considered presumptive high-level tetracycline resistant. Organisms with Minimum inhibitory concentrations > 2.0 micrograms/ml were presumptively considered to have chromosomally mediated resistance to penicillin or tetracycline. Isolates with none of these forms of resistance were considered susceptible to penicillin and tetracycline. RESULTS: Penicillinase-producing N. gonorrhoeae represented 34.7%, 40.7%, and 44.9% of gonococcal isolates in 1988, 1989, and 1990, respectively. Only 14.3% and 15.0% of the isolates in 1991 and 1992 were penicillinase-producing N. gonorrhoeae. In 1988, 1.0% of isolates were chromosomally mediated penicillin resistant. In contrast, chromosomally mediated penicillin resistant gonococci represented 7.5% to 22.4% of isolates from 1989 to 1992. In 1988, 26.0% of isolates were high-level tetracycline resistant. The prevalence of presumptive high-level tetracycline resistant organisms decreased after 1988. From 1989 to 1992, only 8.2% to 14.8% of gonococcal isolates were presumptive high-level tetracycline resistant. No chromosomally mediated tetracycline resistant isolates were identified in 1988. In 1989 and 1990, 11.6% and 10.2%, respectively, of isolates were chromosomally mediated tetracycline resistant. Chromosomally mediated tetracycline resistant N. gonorrhoeae represented 2.0% of isolates in 1991 and 25.0% of isolates in 1992. All isolates tested were susceptible to the other antibiotics. CONCLUSION: Continued surveillance of sensitivity of contemporary gonococci to antimicrobial agents is important.

Comparative evaluation of ofloxacin and metronidazole in the treatment of bacterial vaginosis.

BACKGROUND AND OBJECTIVES: The epidemiology and etiology of bacterial vaginosis is poorly understood. Many antimicrobial agents have been studied and suggested as treatment alternatives for this infection. Fluoroquinolones have in vitro activity against some of the organisms associated with bacterial vaginosis and may provide another treatment option. STUDY DESIGN: Women who presented with symptomatic bacterial vaginosis were randomly assigned to receive either oral ofloxacin 300 mg twice a day or oral metronidazole 500 mg twice a day for seven days. Twenty-seven of the 31 patients who were enrolled in this double-blinded study were evaluable. RESULTS: Fourteen women received ofloxacin. At follow-up, four had no residual symptoms, seven noted a reduction in symptoms, and three had no change in symptoms. Eight (57%) of the 14 women who received ofloxacin had secretions at follow-up that satisfied the criteria for the diagnosis of bacterial vaginosis. Thirteen women received metronidazole. Nine had no residual symptoms and four noted a reduction in symptoms. Eleven (85%) of the 13 women had normal vaginal secretions and two (15%) had secretions that were improved. None of the women who received metronidazole had secretions at follow-up that met the criteria for the diagnosis of bacterial vaginosis. CONCLUSION: We conclude that ofloxacin is less effective than metronidazole in the treatment of bacterial vaginosis.

Comparison of enoxacin and ceftriaxone in the treatment of uncomplicated gonorrhea.

BACKGROUND AND OBJECTIVES: The increasing prevalence of resistant strains of Neisseria gonorrhoeae has prompted investigation of new agents for the treatment of this sexually transmitted disease. GOAL OF THIS STUDY: This study compared the efficacy and safety of a single oral dose of enoxacin to intramuscular ceftriaxone in the treatment of uncomplicated anogenital infection with N. gonorrhoeae. STUDY DESIGN: A randomized open trial was conducted at a sexually transmitted diseases clinic in Brooklyn, New York. Adults with uncomplicated gonorrhea were randomly assigned to receive 400 mg of enoxacin or 250 mg of ceftriaxone. A follow-up examination was conducted 5 to 9 days later. RESULTS: 59 women and 23 men were enrolled; 40 women and 19 men were evaluable. Enoxacin eradicated 18 of 19 endocervical, 10 of 10 urethral, 5 of 5 anorectal, and 3 of 3 pharyngeal gonococcal infections. Ceftriaxone eradicated 20 of 21 pharyngeal gonococcal infections. Fifty-nine pretreatment isolates of N. gonorrhoeae were available for antimicrobial susceptibility testing. The geometric mean minimal inhibitory concentration was 0.03 mg/1 for enoxacin and 0.005 mg/l for ceftriaxone. There were few sides effects in either group, and both drugs were ineffective against concomitant infection with Chlamydia trachomatis. CONCLUSION: Oral enoxacin appears to be a safe and effective method of treatment for anogenital infections caused by N. gonorrhoeae.

Comparison of the Syva MicroTrak enzyme immunoassay and Gen-Probe PACE 2 with cell culture for diagnosis of cervical Chlamydia trachomatis infection in a high-prevalence female population.

Culture is currently considered the "gold standard" for detecting Chlamydia trachomatis infections. We evaluated the Syva MicroTrak enzyme immunoassay (EIA) and Gen-Probe PACE 2 tests, which detect chlamydial antigens and rRNA, respectively. These assays were compared with each other and with culture for the detection of C. trachomatis in cervical specimens obtained from 217 women attending a clinic for sexually transmitted diseases. The prevalence of infection was 22.1% by culture. The sensitivity, specificity, and positive and negative predictive values were 79.2, 98.2, 92.6, and 94.3%, respectively, for EIA. For PACE 2, the respective values were 77.1, 97.6, 90.1, and 93.7%. After corrections for two false-negative cultures, the sensitivities and specificities were 80 and 99.4%, respectively, for the EIA and 78 and 98.8%, respectively, for the probe assay. Quantitative evaluation of the results showed that false-negative results with either assay were associated with cultures that had low inclusion counts or were negative without subpassage. Analysis of nonculture results revealed that 2.3% of the EIA results and 4.6% of the probe assay results were within +/- 30% of the respective assay cutoff values. These included four false-negative (one EIA and three probe) and two false-positive (one EIA and one probe) results. The Syva MicroTrak EIA and the Gen-Probe PACE 2 assay are comparable to but significantly less sensitive than culture. Use of a grey zone may help identify the need for repeat or confirmatory testing.

A comparison of single-dose cefixime with ceftriaxone as treatment for uncomplicated gonorrhea. The Gonorrhea Treatment Study Group.

BACKGROUND: Because of the widespread existence of Neisseria gonorrhoeae resistant to penicillin or tetracycline, ceftriaxone is now recommended for the treatment of gonorrhea. There is, however, a need for effective antibiotics that can be administered orally as an alternative to ceftriaxone, which requires intramuscular administration. Cefixime is an orally absorbed cephalosporin that is active against resistant gonococci and has pharmacokinetic activity suitable for single-dose administration. METHODS AND RESULTS: In a randomized, unblinded multicenter study of 209 men and 124 women with uncomplicated gonorrhea, we compared three single-dose treatment regimens: 400 mg or 800 mg of cefixime, administered orally, and 250 mg of ceftriaxone administered intramuscularly. The overall cure rates were 96 percent for the 400-mg dose of cefixime (89 of 93 patients) (95 percent confidence interval, 93.5 percent to 97.8 percent); 98 percent for the 800-mg dose of cefixime (86 of 88 patients) (95 percent confidence interval, 94.6 percent to 100 percent); and 98 percent for ceftriaxone (92 of 94 patients) (95 percent confidence interval, 94.9 to 100 percent). The cure rates were similar in men and women, and pharyngeal infection was eradicated in 20 of 22 patients (91 percent). Thirty-nine percent of 303 pretreatment gonococcal isolates had one or more types of antimicrobial resistance; the efficacy of all three regimens was independent of the resistance pattern. Chlamydia trachomatis infection persisted in at least half the patients infected in each treatment group. All three regimens were well tolerated. CONCLUSIONS: In the treatment of uncomplicated gonorrhea, a single dose of cefixime (400 or 800 mg) given orally appears to be as effective as the currently recommended regimen of ceftriaxone (250 mg given intramuscularly).

Evaluation of ofloxacin in the treatment of uncomplicated gonorrhea.

In an open study, a single oral dose of 400 mg of ofloxacin was administered to 40 men and 20 women who required treatment for uncomplicated gonococcal infection. Thirty-six men and 13 women were evaluable. Ofloxacin eradicated 49 of 49 urethral or endocervical gonococcal infections and 1 of 1 pharyngeal infection. There were 55 pretreatment isolates of Neisseria gonorrhoeae available for antimicrobial susceptibility testing. Twenty-four (43.6%) produced penicillinase. Eighteen (32.7%) isolates that did not produce penicillinase had penicillin MICs greater than or equal to 1.0 micrograms/mL. Twelve (21.8%) isolates had tetracycline MICs greater than or equal to 16 micrograms/mL. The geometric mean minimal inhibitory concentrations (range) for 55 pretreatment N. gonorrhoeae isolates were: ofloxacin, 0.014 (.0078-.03) micrograms/mL; penicillin, 6.30 (.125-128) micrograms/mL; and tetracycline 1.61 (.03-128) micrograms/mL. There were few side effects. Ofloxacin appears to be an effective and safe oral therapy for the treatment of infections caused by N. gonorrhoeae including infections due to penicillin- and tetracycline-resistant strains.

Vulvar ulcer of unknown etiology in a human immunodeficiency virus-infected woman: response to treatment with zidovudine.

We report a woman who presented with an intractable vulvar ulcer of unknown etiology. Human immunodeficiency virus antibodies and a depressed CD4 lymphocyte count were the only remarkable findings. There was no evidence of syphilis, chancroid, or herpes simplex virus infection. The ulcer healed in association with treatment with zidovudine.

Comparison of ofloxacin and ceftriaxone in the treatment of uncomplicated gonorrhea caused by penicillinase-producing and non-penicillinase-producing strains.

Eighty-nine patients with uncomplicated gonorrhea, including 31 patients (34.8%) infected with penicillinase-producing strains of Neisseria gonorrhoeae, were treated with oral ofloxacin (single 400-mg dose) or intramuscular ceftriaxone (250-mg dose). All 47 patients who received ofloxacin and 41 of 42 patients who received ceftriaxone were cured.