Efficacy of IV/PO moxifloxacin and IV piperacillintazobactam followed by PO amoxicillinclavulanate in the treatment of diabetic foot infections: results of the RELIEF study

Abstract number: P1550

Schaper N., Dryden M., Kujath P., Nathwani D., Arvis P., Reimnitz P., Alder J., Hampel B., Gyssens I.

Objectives: Diabetic foot infections (DFIs) cause substantial morbidity and are a leading cause of lower-extremity amputations. As DFIs are usually polymicrobial, broad-spectrum antibiotics – as well as proper wound care – play an important role. Due to their broad spectrum of activity and pharmacodynamic properties, fluoroquinolones, such as moxifloxacin (MXF), have several potential advantages over other antimicrobial classes. The RELIEF study was conducted to provide further data on the efficacy of MXF in specific complicated skin and skin structure diagnoses. Data on DFIs are presented.

Methods: This was a double-dummy, double-blind, randomised, controlled, multinational trial. Patients with a DFI requiring antimicrobials were stratified according to infection severity and the requirement for surgery, and received either IV/PO MXF 400 mg qd or IV piperacillin/tazobactam 4.0/0.5g tds followed by PO amoxicillin/clavulanate 875/125 mg bd (PIP/TAZ-AMC), for 7–21 days. The DFI diagnosis was based on predetermined criteria, documented by repeated photographs and confirmed by an independent data review committee (DRC). The primary efficacy variable was clinical response 14–28 days after completion of therapy (test-of-cure, TOC) as determined by the DRC.

Results: A total of 206 patients were valid for the PP analysis (MXF=110, PIP/TAZ-AMC=96). There were fewer men in the MXF vs the PIP/TAZ-AMC arm (55.5% vs 71.9%; P = 0.02) and mean HbA1c levels were higher in the MXF vs the PIP/TAZ-AMC arm (9.7% vs 9.0%; P = 0.04). Most patients had moderate-to-severe DFIs with a PEDIS score of 3 (MXF 87/107, 81.3%; PIP/TAZ-AMC 81/94, 86.2%). In the MBV population, polymicrobial infections were common (MXF: 56/92, 60.9%; PIP/TAZ-AMC: 53/85, 62.3%); the most frequently isolated organism overall was S. aureus (MXF 64/92, 69.6%; PIP/TAZ-AMC 69/85, 81.2%). MRSA was isolated from relatively few patients overall (23/206; 11.1%). Initial surgeries were carried out on 150 patients (MXF 78/110, 70.9%; PIP/TAZ 72/96, 75.0%). A total of 23/110 (20.9%) MXF- and 24/96 (25.0%) PIP/TAZ-AMC-treated patients had additional surgeries after the start of therapy. MXF and PIP/TAZ-AMC had similar efficacy with respect to clinical cure at TOC (Table). Bacteriological success rates were also comparable (Table).

Conclusion: In this large randomised trial IV/PO MXF had similar efficacy to IV PIP/TAZ-AMC in the subset of patients with DFI. MXF can be considered a valuable option for the treatment of DFI.

Table 1. Clinical and bacteriological success rates at TOC

 MXF n/N (%)PIP/TAZ-AMC n/N (%)P-value
Clinical cure
PP84/110 (76.4)75/96 (78.1)0.65
MBV69/92 (75.0)64/85 (75.3)0.70
ITT86/123 (69.9)76/110 (69.1)0.98
ITT with organisms71/102 (69.6)65/96 (67.7)0.93
Bacteriological success§
MBV66/92 (71.7)61/85 (71.8)
ITT with organisms69/102 (67.6)62/96 (64.5) 
Bacteriological success by key organism (MBV population)§
Staphylococcus aureus
  Methicillin-susceptible43/53 (81.1)39/57 (68.4) 
  Methicillin-resistant8/11 (72.7)10/12 (83.3) 
Streptococcus pyogenes3/3 (100)2/2 (100)
Enterococcus faecalis19/30 (63.3)20/29 (69.0)
Escherichia coli
  ESBL-producing1/1 (100)1/1 (100) 
  Non ESBL-producing6/8 (75.0)8/11 (72.7) 
Bacteroides fragilis3/3 (100)3/4 (75.0)
Cochran–Mantel–Haenszel test. §n/N = number of patients experiencing eradication or presumed eradication/number of patients with pathogen isolated. ITT: intent-to-treat; PP: per-protocol; MBV: microbiologically valid.

Session Details

Date: 10/04/2010
Time: 00:00-00:00
Session name: Abstracts 20th European Congress of Clinical Microbiology and Infectious Diseases
Location: Vienna, Austria, 10 - 13 April 2010
Presentation type:
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