Evaluation of new anti-infective drugs for the treatment of acute pelvic infections in hospitalized women. Infectious Diseases Society of America and the Food and Drug Administration.

Abstract

This set of guidelines deals with evaluation of anti-infective drugs for treatment of acute pelvic infections in hospitalized women. The clinical entities include infectious complications of cesarean section; elective hysterectomy; and septic, incomplete abortion. Conditions including endomyometritis, cuff cellulitis, pelvic cellulitis, parametritis, phlegmon, and pelvic abscesses may arise due to a variety of bacterial species, both aerobic and anaerobic, that comprise the endogenous flora of the lower reproductive tract. Anaerobic bacteria have assumed particular importance, and therapy should be directed against such organisms. The roles of enterococci, chlamydiae, and mycoplasmas remain uncertain. Culture samples must be obtained under conditions assuring minimal vaginal contamination. Before a new drug may be used for treatment of human pelvic infections, considerable information is necessary about its antimicrobial spectrum as well as its safety and efficacy. Placebo-controlled trials are considered unethical. Historical controls may be used, but concurrent active control comparative trials are preferred. Parenteral administration is recommended for at least the initial 4 days of therapy, but orally administered drugs may be evaluated for completion of longer courses. The expected cure rate is approximately 90%. Uncomplicated infections should be treated for at least 4 days; more complicated infections may require prolonged therapy. Although clinical cure is paramount, microbiologic response must also be taken into account. In the final assessment, outcome will be classified as cure, failure, or indeterminate.