A randomized double-blind comparison of moxifloxacin and doxycycline/metronidazole/ciprofloxacin in the treatment of acute, uncomplicated pelvic inflammatory disease.
This multicentre, double-blind study was undertaken to demonstrate non-inferiority of once-daily oral moxifloxacin compared with combination therapy in the management of acute, uncomplicated pelvic inflammatory disease (PID). Women aged >or=18 years with PID were randomized to receive moxifloxacin (400 mg once daily) for 14 days or comparator treatment (doxycycline [100 mg twice daily] plus metronidazole [400 mg three times daily] for 14 days, plus one single 500-mg ciprofloxacin dose). Of the 434 valid per protocol (PP) patients, the overall clinical success rates at 2-14 days post-therapy were 96.6% (moxifloxacin) and 98.0% (comparator); moxifloxacin was non-inferior to the comparator regimen both in the PP (95% confidence interval [CI]: -4.5, 1.6) and intent-to-treat (95% CI: -5.8, 6.9) populations. Clinical success rates at 21-35 days post-therapy were 93.8% (166/177; data missing for 47 patients) for moxifloxacin and 91.3% (147/161; data missing for 37 patients) for the comparator. Bacteriological success rates at 2-14 days post-therapy were 92.5% (moxifloxacin) and 88.2% (comparator). Once-daily dosing and proven efficacy suggest that moxifloxacin may be of value in acute, uncomplicated PID.
Heystek
M
M
Department of Family Medicine, University of Pretoria, Pretoria, South Africa.
Ross
J D C
JD
D000208:Acute Disease; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001372:Aza Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004318:Doxycycline / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008795:Metronidazole / Q000008:administration & dosage / Q000627:therapeutic use*; D000077266:Moxifloxacin; D000292:Pelvic Inflammatory Disease / Q000188:drug therapy*; D011804:Quinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D008795:Metronidazole; D002939:Ciprofloxacin; D004318:Doxycycline; D000077266:Moxifloxacin