Treating diabetic foot infections with sequential intravenous to oral
moxifloxacin compared with piperacillin-tazobactam/amoxicillin-clavulanate.
Author(s): Lipsky BA, Giordano P, Choudhri S, Song J.
Affiliation(s): VA Puget Sound Health Care System and University of Washington, Seattle, WA, USA.
benjamin.lipsky@med.va.gov
Publication date & source: 2007, J Antimicrob Chemother. , 60(2):370-6
OBJECTIVES: Complicated skin and skin structure infections (cSSSIs), including
diabetic foot infections (DFIs), are often polymicrobial, requiring combination
or broad-spectrum therapy. Moxifloxacin, a broad-spectrum fluoroquinolone, is
approved for cSSSI and can be administered by either intravenous (iv) or oral
routes. To assess the efficacy of moxifloxacin for treating DFIs, we analysed a
subset of patients with these infections who were enrolled in a prospective,
double-blind study that compared the efficacy of moxifloxacin with
piperacillin-tazobactam and amoxicillin-clavulanate.
METHODS: Patients>or=18 years of age with a DFI requiring initial iv therapy were
randomized to either moxifloxacin (400 mg/day) or piperacillin-tazobactam
(3.0/0.375 g every 6 h) for at least 3 days followed by moxifloxacin (400 mg/day
orally) or amoxicillin-clavulanate (800 mg every 12 h orally), if appropriate,
for 7-14 days. DFI was usually defined as any foot infection plus a history of
diabetes. Our primary efficacy outcome was the clinical response of the infection
at test-of-cure (TOC), 10-42 days post-therapy.
RESULTS: Among 617 patients enrolled in the original study, 78 with DFIs were
evaluable for treatment efficacy. Clinical cure rates at TOC were similar for
moxifloxacin and piperacillin-tazobactam/amoxicillin-clavulanate (68% versus 61%)
for patients with investigator-defined infection (P=0.54). Overall pathogen
eradication rates in the microbiologically-valid population were 69% versus 66%
for moxifloxacin and comparator, respectively (P=1.00).
CONCLUSIONS: Intravenous+/-oral moxifloxacin was as effective as iv
piperacillin-tazobactam+/-amoxicillin-clavulanate in treating moderate-to-severe
DFIs. Moxifloxacin may have potential as a monotherapy regimen for DFIs.
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