Evaluation of ofloxacin in the treatment of laparoscopically documented acute pelvic inflammatory disease (salpingitis).

OBJECTIVE: To evaluate the safety and efficacy of intravenous and oral ofloxacin monotherapy in the treatment of laparoscopically documented acute pelvic inflammatory disease (PID). METHODS: This study was conducted as an open-label, phase-III, uncontrolled, multicenter study. Patients identified with laparoscopic findings of salpingitis were treated with 400 mg of intravenous ofloxacin every 12 hours followed by 400 mg of oral ofloxacin every 12 hours for 10 to 14 days. Patients were evaluated five times for clinical and microbial efficacy. Since laparoscopy was performed only at admission, pathogens identified laparoscopically were presumed eradicated if they were present on the laparoscopic culture and the patient was clinically cured or improved at final evaluation. RESULTS: Of the 70 patients evaluable for safety (intent-to-treat population), the mean age was 25.6 years. Sixty-one of 70 patients (87%) were cured, one improved, one did not improve, and seven were unevaluable because they discontinued study participation. Fifty-one were evaluable for clinical efficacy: 50 (98%) were cured and one did not improve. Sixteen were evaluable for expanded microbiological efficacy: three had documented Neisseria gonorrhoeae; 12, Chlamydia trachomatis; and one, a mixed infection of both organisms. All cervical, laparoscopic, and endometrial cultured pathogens, including N. gonorrhoeae and C. trachomatis, were eradicated or presumed eradicated at the posttherapy visit. No serious or unexpected adverse events occurred. CONCLUSIONS: Ofloxacin monotherapy was effective and well tolerated in the treatment of laparoscopically proven PID in a geographically diverse population. Future studies are necessary to evaluate long-term outcomes and sequelae of PID treatment with single agent therapy.