Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in t
- PDF / 306,405 Bytes
- 12 Pages / 595.276 x 790.866 pts Page_size
- 32 Downloads / 169 Views
CLINICAL AND EPIDEMIOLOGICAL STUDY
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 N. C. Schaper • M. Dryden • P. Kujath D. Nathwani • P. Arvis • P. Reimnitz • J. Alder • I. C. Gyssens
•
Received: 9 August 2012 / Accepted: 6 November 2012 / Published online: 23 November 2012 Ó The Author(s) 2012. This article is published with open access at Springerlink.com
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 MXFtreated 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.
N. C. Schaper (&) Department of Internal Medicine, Division of Endocrinology, CARIM and CAPHRI Institute, Maastricht University Medical Center?, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands e-mail: [email protected]
P. Reimnitz Bayer Pharma AG, Wuppertal, Germany
M. Dryden Royal Hampshire County Hospital, Winchester, Hampshire, UK
I. C. Gyssens Department of Medicine, Nijmegen Institute for Infection, Inflammation and Immunity (N4i), Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
P. Kujath University Clinic of Luebeck, Ratzeburger Allee 160, Luebeck, Germany D. Nathwani Infection Unit, Ninewells Hospital and Medical School, Dundee, UK P. Arvis Bayer HealthCa
Data Loading...
