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.
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.
  
  
  CONCLUSIONS
  Moxifloxacin has shown favorable safety and efficacy profiles in DFI patients and could be an alternative antibiotic therapy in the management of DFI.
  
  
  BACKGROUND
  NCT00402727.
authors.affiliation: Department of Internal Medicine, Division of Endocrinology, CARIM and CAPHRI Institute, Maastricht University Medical Center+, P.O. Box 5800, 6202 AZ, Maastricht, The Netherlands. n.schaper@mumc.nl
authors.forename: N C
authors.initials: NC
authors.lastname: Schaper
authors.forename: M
authors.initials: M
authors.lastname: Dryden
authors.forename: P
authors.initials: P
authors.lastname: Kujath
authors.forename: D
authors.initials: D
authors.lastname: Nathwani
authors.forename: P
authors.initials: P
authors.lastname: Arvis
authors.forename: P
authors.initials: P
authors.lastname: Reimnitz
authors.forename: J
authors.initials: J
authors.lastname: Alder
authors.forename: I C
authors.initials: IC
authors.lastname: Gyssens
mesh_terms: D061605:Administration, Intravenous; D000284:Administration, Oral; D000368:Aged; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001372:Aza Compounds / Q000008:administration & dosage; D001419:Bacteria / Q000145:classification / Q000187:drug effects / Q000302:isolation & purification; D001424:Bacterial Infections / Q000150:complications* / Q000188:drug therapy*; D017719:Diabetic Foot / Q000150:complications*; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D000077266:Moxifloxacin; D010397:Penicillanic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D010878:Piperacillin / Q000008:administration & dosage; D011804:Quinolines / Q000008:administration & dosage; D000078142:Tazobactam; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D019980:Amoxicillin-Potassium Clavulanate Combination; D010397:Penicillanic Acid; D000078142:Tazobactam; D000077266:Moxifloxacin; D010878:Piperacillin