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      A randomized trial of the efficacy and safety of sequential intravenous/oral moxifloxacin monotherapy versus intravenous piperacillin/tazobactam followed by oral amoxicillin/clavulanate for complicated skin and skin structure infections

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          Abstract

          Objectives

          The primary aim of the RELIEF study was to evaluate the efficacy and safety of two sequential intravenous (iv)/oral regimens: moxifloxacin iv/oral versus piperacillin/tazobactam (TZP) iv followed by oral amoxicillin/clavulanate (AMC).

          Patients and methods

          The study had a prospective, randomized, double-dummy, double-blind, multicentre design. Patients ≥18 years were prospectively stratified according to complicated skin and skin structure infection (cSSSI) subtype/diagnosis (major abscess, diabetic foot infection, wound infection or infected ischaemic ulcer), surgical intervention and severity of illness. Diagnoses and disease severity were based on predetermined criteria, documented by repeated photographs, and confirmed by an independent data review committee. Patients were randomized to receive either 400 mg of moxifloxacin iv once daily followed by 400 mg of moxifloxacin orally once daily or 4.0/0.5 g of TZP iv thrice daily followed by 875/125 mg of AMC orally twice daily for 7–21 days. The primary efficacy variable was clinical response at test of cure (TOC) for the per-protocol (PP) population. Clinical efficacy was assessed by the data review committee based on repeated photographs and case descriptions. Clinical trials registry number: NCT 00402727.

          Results

          A total of 813 patients were randomized. Clinical success rates at TOC were similar for moxifloxacin and TZP–AMC in the PP [320/361 (88.6%) versus 275/307 (89.6%), respectively; P = 0.758] and intent-to-treat (ITT) [350/426 (82.2%) versus 305/377 (80.9%), respectively; P = 0.632] populations. Thus, moxifloxacin was non-inferior to TZP–AMC. Bacteriological success rates were high in both treatment arms [moxifloxacin: 432/497 (86.9%) versus TZP–AMC: 370/429 (86.2%), microbiologically valid (MBV) population]. Moxifloxacin was non-inferior to TZP–AMC at TOC in both the MBV and the ITT populations. Both treatments were well tolerated.

          Conclusions

          Once-daily iv/oral moxifloxacin monotherapy was clinically and bacteriologically non-inferior to iv TZP thrice daily followed by oral AMC twice daily in patients with cSSSIs.

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          Most cited references37

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          The dysvascular foot: a system for diagnosis and treatment.

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            Managing skin and soft tissue infections: expert panel recommendations on key decision points.

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              Ertapenem versus piperacillin/tazobactam for diabetic foot infections (SIDESTEP): prospective, randomised, controlled, double-blinded, multicentre trial.

              Diabetic foot infections are a common and serious problem, yet few randomised trials of adequate quality have compared the efficacy of the various antibiotic regimens available for their treatment. Our aim was to assess the efficacy and safety of ertapenem versus piperacillin/tazobactam for foot infections. We did a randomised, double-blinded, multicentre trial in adults (n=586) with diabetes and a foot infection classified as moderate-to-severe and requiring intravenous antibiotics. We assigned patients intravenous ertapenem (1 g daily; n=295) or piperacillin/tazobactam (3.375 g every 6 h; n=291) given for a minimum of 5 days, after which oral amoxicillin/clavulanic acid (875/125 mg every 12 h) could be given for up to 23 days. Investigators retained the option to administer vancomycin to patients in either group to ensure adequate coverage for potentially antibiotic resistant Enterococcus spp and meticillin-resistant Staphylococcus aureus (MRSA). Our primary outcome was the proportion of patients with a favourable clinical response (cure or improvement) on the day that intravenous antibiotic was discontinued. Analyses were by an evaluable-patient only approach. This study is registered with , number NCT00229112. Of the 576 patients treated, 445 were available for assessment at the end of intravenous therapy. Both baseline characteristics and favourable clinical response rates were similar for the 226 who received ertapenem and the 219 who received piperacillin/tazobactam (94%vs 92%, respectively; between treatment difference 1.9%, 95% CI -2.9 to 6.9). Rates of favourable microbiological responses (eradication rates and clinical outcomes, by pathogen) and adverse events did not differ between groups. Clinical and microbiological outcomes for patients treated with ertapenem were equivalent to those for patients treated with piperacillin/tazobactam, suggesting that this once-daily antibiotic should be considered for parenteral therapy of diabetic foot infections, when deemed appropriate.
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                Author and article information

                Journal
                J Antimicrob Chemother
                jac
                jac
                Journal of Antimicrobial Chemotherapy
                Oxford University Press
                0305-7453
                1460-2091
                November 2011
                6 September 2011
                6 September 2011
                : 66
                : 11
                : 2632-2642
                Affiliations
                [1 ]simpleRadboud University Nijmegen Medical Center , Nijmegen, The Netherlands
                [2 ]simpleCanisius Wilhelmina Hospital , Nijmegen, The Netherlands
                [3 ]simpleHasselt University , Diepenbeek, Belgium
                [4 ]simpleRoyal Hampshire County Hospital , Winchester, Hampshire, UK
                [5 ]simpleUniversity Clinic of Luebeck , Luebeck, Germany
                [6 ]simpleNinewells Hospital and Medical School , Dundee, UK
                [7 ]simpleUniversity Hospital Maastricht , Maastricht, The Netherlands
                [8 ]simpleBayer Healthcare Pharmaceuticals , Berlin, Germany
                [9 ]simpleBayer Healthcare Pharmaceuticals , Wuppertal, Germany
                [10 ]simpleBayer Healthcare , Montville, NJ, USA
                [11 ]simpleBayer Healthcare Pharmaceuticals , Loos, France
                Author notes
                [* ]Corresponding author. Department of Internal Medicine, AIG-463, Radboud University Nijmegen Medical Center, Geert Grooteplein 10, 6525 GA Nijmegen, The Netherlands. Tel: +31-24-3618819; Fax: +31-24-3541734; E-mail: i.gyssens@ 123456aig.umcn.nl
                Article
                dkr344
                10.1093/jac/dkr344
                3191944
                21896561
                db6b9e41-ae75-4e7b-8fe7-439322c5efec
                © The Author 2011. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/2.5), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited

                History
                : 22 February 2011
                : 3 April 2011
                : 22 July 2011
                : 26 July 2011
                Categories
                Original Research

                Oncology & Radiotherapy
                fluoroquinolones,randomized controlled trials,sequential therapy,soft tissue infections,β-lactams

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