Efficacy and safety of moxifloxacin in hospitalized patients with secondary
peritonitis: pooled analysis of four randomized phase III trials.
Author(s): De Waele JJ(1), Tellado JM, Weiss G, Alder J, Kruesmann F, Arvis P, Hussain T,
Solomkin JS.
Affiliation(s): Author information:
(1)1 Department of Critical Care Medicine, Ghent University Hospital , Ghent,
Belgium .
Publication date & source: 2014, Surg Infect (Larchmt). , 15(5):567-75
BACKGROUND: Secondary peritonitis is an advanced form of complicated
intra-abdominal infection (cIAI) requiring hospitalization, surgical source
control, and empiric antibiotic therapy against causative aerobic and anaerobic
bacteria.
METHODS: This pooled analysis of four prospective, active-controlled randomized
clinical trials compared the efficacy and safety of moxifloxacin with that of
comparator antibiotics in patients with confirmed secondary peritonitis. The
primary efficacy endpoint was clinical success rate at test-of-cure (TOC) between
day 10 and 45 post-therapy in the per-protocol (PP) population. Safety and
clinical efficacy were assessed also in the intent-to-treat population (ITT).
Bacteriological success was assessed at TOC in the microbiologically-valid
population as a secondary efficacy endpoint.
RESULTS: Overall clinical success rates at TOC were 85.3% (431 of 505 patients)
in the moxifloxacin and 88.4% (459 of 519 patients) in the comparator treatment
groups (PP population, point estimate for the difference in success rates: -3.0%;
95% CI -7.06%, 1.05%), respectively. Similar clinical success rates between
moxifloxacin and comparators were observed by anatomical site of infection, and
ranged from 80.6% to 100% for moxifloxacin and from 71.4% to 96.6% for
comparators, respectively. Bacteriologic success rates were similar with
moxifloxacin (82.4%) and comparators (86.8%), respectively. The proportion of
patients experiencing any treatment-emergent adverse events was slightly higher
with moxifloxacin (67.3%) versus comparators (59.8%). Rates of drug-related
adverse events (20.9% versus 20.0%) and deaths (4.3% versus 3.4%) were similar in
moxifloxacin and comparator groups; none of the deaths were drug-related.
CONCLUSIONS: The data suggests that once-daily IV (or IV/PO) moxifloxacin has a
comparable efficacy and safety profile to antibiotic regimens approved previously
in the subgroup of patients with secondary peritonitis of mild-to-moderate
severity.
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