Randomized controlled trial of moxifloxacin compared with piperacillin-tazobactam and amoxicillin-clavulanate for the treatment of complicated intra-abdominal infections.
OBJECTIVE
To compare the safety and efficacy of sequential intravenous (IV) to oral (PO) moxifloxacin treatment against a standard antimicrobial regimen of IV piperacillin-tazobactam followed by PO amoxicillin-clavulanate for the treatment of adults with complicated intra-abdominal infection (cIAI).


BACKGROUND
cIAIs are commonly due to mixed aerobic and anaerobic bacteria and require both source control and broad-spectrum antibiotic therapy.


METHODS
A prospective, double-blind, randomized, phase III comparative trial. Patients with cIAI were stratified by disease severity (APACHE II score) and randomized to either IV/PO moxifloxacin (400 mg q24 hours) or comparator (IV piperacillin-tazobactam [3.0/0.375 g q6 hours] +/- PO amoxicillin-clavulanate [800 mg/114 mg q12 hours]), each for 5 to 14 days. The primary efficacy variable was clinical cure rate at the test-of-cure visit (days 25-50). Bacteriologic outcomes were also determined.


RESULTS
: Of 656 intent-to-treat patients, 379 (58%) were valid to assess efficacy (183 moxifloxacin, 196 comparator). Demographic and baseline medical characteristics were similar between the 2 groups. Clinical cure rates at test-of-cure were 80% (146 of 183) for moxifloxacin versus 78% (153 of 196) for comparator (95% confidence interval, -7.4%, 9.3%). The clinical cure rate at test-of-cure for hospital-acquired cIAI was higher with moxifloxacin (82%, 22 of 27) versus comparator (55%, 17 of 31; P = 0.05); rates were similar for community-acquired infections (80% [124 of 156] versus 82% [136 of 165], respectively). Bacterial eradication rates were 78% (117 of 150) with moxifloxacin versus 77% (126 of 163) in the comparator group (95% confidence interval, -9.9%, 8.7%).


CONCLUSIONS
Once daily IV/PO moxifloxacin monotherapy was as least as effective as standard IV piperacillin-tazobactam/PO amoxicillin-clavulanate dosed multiple times daily for the treatment of cIAIs.
Malangoni
Mark A
MA
Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH 44109-1998, USA. mmalangoni@metrohealth.org
Song
James
J
Herrington
Janet
J
Choudhri
Shurjeel
S
Pertel
Peter
P
D018784:Abdominal Abscess / Q000188:drug therapy* / Q000382:microbiology; D000284:Administration, Oral; D000328:Adult; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001064:Appendicitis / Q000150:complications; D001372:Aza Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D003428:Cross Infection / Q000188:drug therapy; D004311:Double-Blind Method; D005260:Female; D024841:Fluoroquinolones; D016905:Gram-Negative Bacterial Infections / Q000188:drug therapy; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy; D006801:Humans; D007275:Injections, Intravenous; D007416:Intestinal Perforation / Q000150:complications; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D010397:Penicillanic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D010878:Piperacillin / Q000627:therapeutic use; D000077725:Piperacillin, Tazobactam Drug Combination; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D012449:Safety; D013275:Stomach Rupture / Q000150:complications; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D000077725:Piperacillin, Tazobactam Drug Combination; D019980:Amoxicillin-Potassium Clavulanate Combination; D010397:Penicillanic Acid; D000077266:Moxifloxacin; D010878:Piperacillin