Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study.
OBJECTIVE
To evaluate the efficacy and safety of moxifloxacin versus levofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease (uPID) in Asia.


METHODS
Prospective, randomised, double-blind, double-dummy, parallel-group study.


METHODS
Multicentre, multinational study in the inpatient and/or outpatient setting.


METHODS
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.


METHODS
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. Non-inferiority 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.
Judlin
P
P
Pôle de Gynécologie, Obstétrique et Reproduction, Maternité Régionale Universitaire de Nancy, Université Henri-Poincaré, 10 rue du Dr Heydenreich, Nancy, France. p.judlin@maternite.chu-nancy.fr
Liao
Q
Q
Liu
Z
Z
Reimnitz
P
P
Hampel
B
B
Arvis
P
P
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001372:Aza Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D064704:Levofloxacin; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D000077266:Moxifloxacin; D015242:Ofloxacin / Q000008:administration & dosage / Q000009:adverse effects; D000292:Pelvic Inflammatory Disease / Q000188:drug therapy*; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
D000900:Anti-Bacterial Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D008795:Metronidazole; D064704:Levofloxacin; D015242:Ofloxacin; D000077266:Moxifloxacin