Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed
by PO amoxicillin/clavulanic acid in the treatment of diabetic foot infections:
results of the RELIEF study.
Author(s): Schaper NC(1), Dryden M, Kujath P, Nathwani D, Arvis P, Reimnitz P, Alder J,
Gyssens IC.
Affiliation(s): Author information:
(1)Department of Internal Medicine, Division of Endocrinology, CARIM and CAPHRI
Institute, Maastricht University Medical Center+, P.O. Box 5800, 6202 AZ,
Maastricht, The Netherlands. n.schaper@mumc.nl
Publication date & source: 2013, Infection. , 41(1):175-86
OBJECTIVE: The aim was to compare the efficacy and safety of two antibiotic
regimens in patients with diabetic foot infections (DFIs).
METHODS: Data of a subset of patients enrolled in the RELIEF trial with DFIs
requiring surgery and antibiotics were evaluated retrospectively. DFI was
diagnosed on the basis of the modified Wagner, University of Texas, and PEDIS
classification systems. Patients were randomized to receive either
intravenous/oral moxifloxacin (MXF, N = 110) 400 mg q.d. or intravenous
piperacillin/tazobactam 4.0/0.5 g t.d.s. followed by oral amoxicillin/clavulanate
875/125 mg b.d. (PIP/TAZ-AMC, N = 96), for 7-21 days until the end of treatment
(EOT). The primary endpoint was clinical cure rates in the per-protocol (PP)
population at the test-of-cure visit (TOC, 14-28 days after EOT).
RESULTS: There were no significant differences between the demographic
characteristics of PP patients in either treatment group. At TOC, MXF and
PIP/TAZ-AMC had similar efficacy in both the PP and intent-to-treat (ITT)
populations: MXF: 76.4 % versus PIP/TAZ-AMC: 78.1 %; 95 % confidence interval
(CI) -14.5 %, 9.0 % in the PP population; MXF: 69.9 % versus PIP/TAZ-AMC: 69.1 %;
95 % CI -12.4 %, 12.1 % in the ITT population. The overall bacteriological
success rates were similar in both treatment groups (MXF: 71.7 % versus
PIP/TAZ-AMC: 71.8 %; 95 % CI -16.9 %, 10.7 %). A similar proportion of patients
(ITT population) experienced any adverse events in both treatment groups (MXF:
30.9 % versus PIP/TAZ-AMC: 31.8 %, respectively). Death occurred in three
MXF-treated patients and one PIP/TAZ-AMC-treated patient; these were unrelated to
the study drugs.
CONCLUSION: Moxifloxacin has shown favorable safety and efficacy profiles in DFI
patients and could be an alternative antibiotic therapy in the management of DFI.
CLINICAL TRIAL: NCT00402727.
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