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Moxifloxacin versus ofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease: results of a multicentre, double blind, randomised trial
  1. J D C Ross1,
  2. H S Cronjé2,
  3. T Paszkowski3,
  4. I Rakoczi4,
  5. D Vildaite5,
  6. A Kureishi6,
  7. M Alefelder7,
  8. P Arvis8,
  9. P Reimnitz7,
  10. on behalf of the MAIDEN Study Group*
  1. 1Whittall Street Clinic, Birmingham, UK
  2. 2Department of Obstetrics and Gynaecology, University of the Free State, Bloemfontein, South Africa
  3. 3Department of Gynecology, Medical University of Lublin, Lublin, Poland
  4. 4Department of Obstetrics and Gynecology, St Imre Teaching Hospital, Budapest, Hungary
  5. 5Department of Gynecology, Vilnius Hospital of Emergency Care, Vilnius, Lithuania
  6. 6Bayer Healthcare Group, Wuppertal, Germany
  7. 7Bayer Vital, Leverkusen, Germany
  8. 8Bayer Pharma, Puteaux, France
  1. Correspondence to:
 J D C Ross
 Whittall Street Clinic, Whittall Street, Birmingham B4 6DH, UK; jonathan.ross{at}hobtpct.nhs.uk

Abstract

Objective: This multinational, multicentre, prospective, randomised, double blind, parallel group, non-inferiority study compared the efficacy and safety of moxifloxacin monotherapy with ofloxacin plus metronidazole in women with uncomplicated pelvic inflammatory disease.

Methods: Women from hospitals throughout 13 countries received a 14 day course of either oral moxifloxacin, 400 mg once daily (n = 384), or oral ofloxacin, 400 mg twice daily plus oral metronidazole, 500 mg twice daily (n = 365).

Results: Of the 741 patients in the intent to treat (ITT) population, 564 (74.2%) were valid for the per protocol (PP) analyses; 112 (19.9%) of these were included in the microbiologically valid population (MBV). Clinical resolution rates in the PP population at the test of cure visit (TOC, 5–24 days post-therapy, primary efficacy end point) were 90.2% (248/275) for moxifloxacin and 90.7% (262/289) for ofloxacin plus metronidazole (95% CI: −5.7% to 4.0%). At follow up (28–42 days post-therapy), resolution rates in the PP population were 85.8% (236/275) and 87.9% (254/289) for moxifloxacin and comparator, respectively (95% CI: −8.0% to 3.1%). Bacteriological success rates in the MBV population at TOC were 87.5% (49/56) for moxifloxacin and 82.1% (46/56) for comparator (95% CI: −8.3% to 18.8%). Against Chlamydia trachomatis and Neisseria gonorrhoeae, bacteriological success rates with moxifloxacin were 88.5% (23/26) and 100% (13/13) and for comparator 85.7% (18/21) and 81.8% (18/22), respectively. Drug related adverse events occurred less frequently with moxifloxacin (22.5% (85/378)) versus the comparator (30.9% (112/363)) (p = 0.01).

Conclusion: In uncomplicated PID, once daily moxifloxacin monotherapy was clinically and bacteriologically as efficacious as twice daily ofloxacin plus metronidazole therapy and was associated with fewer drug related adverse events.

  • CMV, cytomegalovirus
  • ITT, intent to treat
  • IUD, intrauterine device
  • MBV, microbiologically valid population
  • PCR, polymerase chain reaction
  • PID, pelvic inflammatory disease
  • PP, per protocol
  • STD, sexually transmitted diseases
  • TOC, test of cure
  • antimicrobial therapy
  • fluoroquinolone monotherapy
  • moxifloxacin
  • ofloxacin/metronidazole
  • pelvic inflammatory disease

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Footnotes

  • * See end of text for a full list of the MAIDEN Study Group.

  • This study was supported by a grant from Bayer HealthCare.

  • Competing interests: No competing interests are declared for HC, TP, IR, or DV. JR has received payment as a consultant and lecturer, and sponsorship to attend medical conferences from Bayer HealthCare. JR is an associate editor of Sexually Transmitted Infections. AK, MA, PA, and PR are employees of Bayer HealthCare.

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