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JAC Advance Access originally published online on June 6, 2007
Journal of Antimicrobial Chemotherapy 2007 60(2):370-376; doi:10.1093/jac/dkm130
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Published by Oxford University Press 2007

Treating diabetic foot infections with sequential intravenous to oral moxifloxacin compared with piperacillin–tazobactam/amoxicillin–clavulanate

Benjamin A. Lipsky1,*, Philip Giordano2, Shurjeel Choudhri3 and James Song4

1 VA Puget Sound Health Care System and University of Washington, Seattle, WA, USA 2 Orlando Regional Medical Center, Orlando, FL, USA 3 Bayer Healthcare, West Haven, CT, USA 4 Replidyne, Milford, CT, USA

Received 23 February 2007; returned 21 March 2007; revised 28 March 2007; accepted 5 April 2007


* Corresponding author. Tel: +1-206-277-1640; E-mail: benjamin.lipsky{at}med.va.gov

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 ≥ 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.

Keywords: complicated skin and skin structure infections , fluoroquinolones , penicillins , ß-lactam inhibitors


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