Clin Infect Dis. 1992 Nov;15:S115-22. doi: 10.1093/clind/15.supplement_1.s115.

Evaluation of new anti-infective drugs for the treatment of vaginal infections. Infectious Diseases Society of America and the Food and Drug Administration.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

J A McCutchan, A R Ronald, L Corey, H H Handsfield

PMID: 1477218 DOI: 10.1093/clind/15.supplement_1.s115

Abstract

The three major vaginal infections are yeast vulvovaginitis, Trichomonas vaginalis vaginitis, and bacterial vaginosis. In terms of signs and symptoms, these disorders overlap substantially with one another and with other infections. Therefore, the diagnosis of candidiasis and trichomoniasis requires isolation of the responsible pathogen. For the diagnosis of bacterial vaginosis, all other potential causes of vaginal infection must be excluded and specified laboratory criteria must be met. Clinical trials must be carefully designed to control for coexisting pathogens, for potential efficacy of treatment against more than one microbe, and for variable end points used to define clinical response. Prospective, randomized, double-blind, active-control comparative studies are preferred. Follow-up evaluations 5-7 days and 4-6 weeks after the completion of therapy are required for the assessment of outcome. Laboratory studies of vaginal fluid (culture and/or microscopic examination) are paramount in the final appraisal of outcome.

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Substances

• Anti-Infective Agents

MeSH terms

• Anti-Infective Agents / therapeutic use
• Candidiasis, Vulvovaginal / drug therapy
• Clinical Trials as Topic / standards
• Clinical Trials, Phase II as Topic / standards
• Female
• Humans
• Research Design
• Trichomonas Vaginitis / drug therapy
• Vaginitis / drug therapy
• Vaginosis, Bacterial / drug therapy
• Vulvovaginitis / drug therapy

Publication Types

• Guideline
• Journal Article
• Research Support, U.S. Gov't, P.H.S.

Grant support

• HHS 223-88-1301/HS/AHRQ HHS/United States

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