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|Title: ||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|
|Authors: ||Schaper, N. C.|
Gyssens, I. C.
|Issue Date: ||2013|
|Publisher: ||SPRINGER HEIDELBERG|
|Citation: ||INFECTION, 41 (1), p. 175-186|
|Abstract: ||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.|
|Notes: ||[Schaper, N. C.] Maastricht Univ, Med Ctr, CARIM, Dept Internal Med,Div Endocrinol, NL-6202 AZ Maastricht, Netherlands. [Schaper, N. C.] Maastricht Univ, Med Ctr, CAPHRI Inst, NL-6202 AZ Maastricht, Netherlands. [Dryden, M.] Royal Hampshire Cty Hosp, Winchester, Hants, England. [Kujath, P.] Univ Clin Luebeck, Lubeck, Germany. [Nathwani, D.] Univ Dundee, Ninewells Hosp & Med Sch, Infect Unit, Dundee DD1 9SY, Scotland. [Arvis, P.] Bayer HealthCare, Loos, France. [Reimnitz, P.] Bayer Pharma AG, Wuppertal, Germany. [Alder, J.] Bayer HealthCare, Montville, NJ USA. [Gyssens, I. C.] Radboud Univ Nijmegen, Med Ctr, Nijmegen Inst Infect Inflammat & Immun N4i, Dept Med, NL-6525 ED Nijmegen, Netherlands. [Gyssens, I. C.] Canisius Wilhelmina Hosp, Dept Med Microbiol & Infect Dis, Nijmegen, Netherlands. [Gyssens, I. C.] Hasselt Univ, Diepenbeek, Belgium.|
|ISI #: ||000315756200023|
|Type: ||Journal Contribution|
|Validation: ||ecoom, 2014|
|Appears in Collections: ||Research publications|
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