Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study

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.