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

Abstract

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.Keywords Levofloxacin, metronidazole, moxifloxacin, 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.

A review of antibiotic therapy for pelvic inflammatory disease

“…Although not included in the CDC recommendations, four large randomised controlled trials have demonstrated the effectiveness of moxifloxacin for the management of PID [41,42,50,51]. The total number of patients receiving moxifloxacin in clinical studies is larger than for any of the other recommended antibiotic regimens, the studies are amongst the most recent available for PID, and fulfil most of the CONSORT (Consolidated Standards of Reporting Trials) recommendations for reporting.…”

“…In one of the studies, 9/228 (3.9%) of the patients receiving moxifloxacin withdrew from treatment after experiencing a drugrelated side effect [51]. In the Ross et al study, 24/378 patients (6.3%) ceased moxifloxacin administration due to side effects [42], whilst 7/578 (1.2%) withdrew from treatment in the Aş icioglu et al trial [41].…”

Pelvic inflammatory disease in the adolescent

“…Recent studies [49,50] have concluded that the use of moxifloxacin (400 mg once daily for 14 days) is as effective as the combination of ofloxacin with metronidazole in uncomplicated PID.…”

Small pelvic inflammatory diseases: Diagnosis and patient management tactics

“…Эти данные уже нашли отражение в европейских (2007, 2012) и британских (2011) рекомендациях по ведению пациен-ток с ВЗОМТ, где единственный препарат -моксифлок-сацин -рекомендуется для амбулаторного лечения в ре-жиме монотерапии [7,13,[27][28][29].…”