Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study
Article first published online: 18 AUG 2010
© 2010 The Authors Journal compilation © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology
BJOG: An International Journal of Obstetrics & Gynaecology
Volume 117, Issue 12, pages 1475–1484, November 2010
How to Cite
Judlin, P., Liao, Q., Liu, Z., Reimnitz, P., Hampel, B. and Arvis, P. (2010), Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study. BJOG: An International Journal of Obstetrics & Gynaecology, 117: 1475–1484. doi: 10.1111/j.1471-0528.2010.02687.x
- Issue published online: 11 OCT 2010
- Article first published online: 18 AUG 2010
- Accepted 30 June 2010. Published Online 18 August 2010.
- uncomplicated pelvic inflammatory disease
Please cite this paper as: Judlin P, Liao Q, Liu Z, Reimnitz P, Hampel B, Arvis P. Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study. BJOG 2010;117:1475–1484.
Objective To evaluate the efficacy and safety of moxifloxacin versus levofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease (uPID) in Asia.
Design Prospective, randomised, double-blind, double-dummy, parallel-group study.
Setting Multicentre, multinational study in the inpatient and/or outpatient setting.
Population Women (aged ≥18 years) with uPID (defined as PID with no pelvic or tubo-ovarian abscess on pelvic ultrasonography and at laparoscopic examination) and not requiring intravenous treatment.
Methods Women received a 14-day course of either oral moxifloxacin, 400 mg once daily, or oral levofloxacin, 500 mg once daily, plus oral metronidazole, 500 mg twice daily. Additionally, a single dose of ceftriaxone, 250 mg intramuscularly, was administered to women who had a positive screening test for Neisseria gonorrhoeae.
Main outcome measures The primary measure of efficacy was clinical response at test-of-cure (TOC) (7–14 days after the last dose of study drug) in the per-protocol population. Noninferiority of moxifloxacin to the comparator regimen was demonstrated if lower limit of 95% CI was >−15%. Other measures were clinical response during therapy and at 4-week follow up, microbiological response at TOC, and safety.
Results A total of 460 women were randomised to the study. For the primary measure of efficacy (clinical cure at TOC), moxifloxacin was noninferior to levofloxacin plus metronidazole (moxifloxacin: 152/194, 78.4%; comparator 155/190, 81.6%; 95% CI −10.7 to +4.9). The most commonly isolated pathogens at baseline included Neisseria gonorrhoeae, Chlamydia trachomatis, Escherichia coli, Staphylococcus aureus, Peptostreptococcus spp., Proteus mirabilis, Streptococcus agalactiae and Klebsiella pneumoniae. Bacteriological success rates were high and comparable between treatment arms (microbiologically valid populations, moxifloxacin 27/30, 90.0%; comparator 22/26, 84.6%; 95% CI −12.7 to +20.3). Both treatments were well tolerated.
Conclusions Moxifloxacin monotherapy, 400 mg once daily for 14 days, is an effective and well-tolerated oral treatment for women with uPID.