title: Single daily dose of moxifloxacin versus ofloxacin plus metronidazole as a new treatment approach to uncomplicated pelvic inflammatory disease: a multicentre prospective randomized trial.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of moxifloxacin versus ofloxacin plus metronidazole in patients with uncomplicated pelvic inflammatory disease (uPID; defined as PID symptoms and signs, but no complications such as septicemia, perihepatitis, and tubo-ovarian abscess) in Turkey.
  
  
  METHODS
  This was a multicenter, prospective, randomized, parallel-group study conducted between June 2010 and March 2013 in four hospitals in Turkey. Women received a 14-day course of either oral moxifloxacin at 400mg once daily (n = 560) or oral ofloxacin at 400mg twice daily plus oral metronidazole at 500 mg twice daily (n = 543).
  
  
  RESULTS
  A total of 1156 women were randomized to the study. Total compliance was achieved in 1103 patients. For the primary measure of efficacy (clinical cure), moxifloxacin showed no difference compared with ofloxacin plus metronidazole (445/560 [79.5%] vs. 449/543 [82.7%]; p = 0.172). Bacteriological cure rates were high and comparable between treatment arms (99/119 [83.2%] vs. 93/110 [84.5%]; p = 0.781). Drug-related adverse events occurred less frequently with moxifloxacin than with ofloxacin plus metronidazole (210/560 [37.5%] vs. 252/543 [46.4%]; p = 0.003). Furthermore, moxifloxacin treatment was lower in cost and achieved higher patient compliance compared with ofloxacin plus metronidazole (31.4 Euros vs. 23.4 Euros and 7/578 (1.2%) vs. 22/578 (3.8%), respectively; p = 0.005).
  
  
  CONCLUSIONS
  In patients with uPID, once-daily moxifloxacin monotherapy was clinically and microbiologically as efficacious as twice-daily ofloxacin plus metronidazole therapy and was associated with fewer drug-related adverse events, lower patient non-compliance, and a lower treatment cost.
authors.affiliation: Şişli Etfal Training and Research Hospital, Department of Obstetrics and Gynecology, İstanbul, Turkey. Electronic address: oasicioglu@yahoo.com.tr.
authors.forename: Osman
authors.initials: O
authors.lastname: Aşicioğlu
authors.forename: Kemal
authors.initials: K
authors.lastname: Gungorduk
authors.forename: Aykut
authors.initials: A
authors.lastname: Ozdemir
authors.forename: Ibrahim Egemen
authors.initials: IE
authors.lastname: Ertas
authors.forename: Gökhan
authors.initials: G
authors.lastname: Yildirim
authors.forename: Muzaffer
authors.initials: M
authors.lastname: Sanci
authors.forename: Cemal
authors.initials: C
authors.lastname: Ark
mesh_terms: D000293:Adolescent; D000328:Adult; D001372:Aza Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D004359:Drug Therapy, Combination; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008795:Metronidazole / Q000008:administration & dosage* / Q000009:adverse effects; D000077266:Moxifloxacin; D015242:Ofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D010349:Patient Compliance; D000292:Pelvic Inflammatory Disease / Q000188:drug therapy* / Q000382:microbiology; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics
chemical_list: D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D008795:Metronidazole; D015242:Ofloxacin; D000077266:Moxifloxacin
keywords: Moxifloxacin; Pelvic inflammatory disease; Randomized trial