Abstract
ObjectiveThe aim was to compare the efficacy and safety of two antibiotic regimens in patients with diabetic foot infections (DFIs).MethodsData 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).ResultsThere 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.ConclusionMoxifloxacin 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.
Highlights
Diabetic foot infections (DFIs) are the most common cause of hospitalization in people with diabetes, accounting for more hospital bed days than any other diabetic complication [1]
There were no significant differences between the demographic characteristics of PP patients in either treatment group
The rationale of the RELIEF study was to provide additional data on the efficacy and safety of MXF in four specific complicated skin and skin structure infections (cSSSIs) diagnoses [22]; the present paper reports on the efficacy and safety of MXF versus a b-lactam/b-lactamase inhibitor combination in the subgroup of patients with diabetic foot infections (DFIs)
Summary
Diabetic foot infections (DFIs) are the most common cause of hospitalization in people with diabetes, accounting for more hospital bed days than any other diabetic complication [1]. Peripheral arterial disease (PAD) is common in patients with DFI, and is an important predictor of outcome [7]. For this reason, the Infectious Diseases Society of America (IDSA) has recommended the inclusion of PAD patients in order to improve the quality of clinical trials evaluating antimicrobial therapy in skin and soft tissue infection. The Infectious Diseases Society of America (IDSA) has recommended the inclusion of PAD patients in order to improve the quality of clinical trials evaluating antimicrobial therapy in skin and soft tissue infection Despite this recommendation, few patients with PAD have been included in DFI trials to date [8] and outcome data in this population are lacking
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