Efficacy of IV/oral moxifloxacin and IV piperacillin/tazobactam followed by oral amoxicillin-clavulanic acid in the treatment of major abscess: results of the RELIEF study
Abstract number: P1786
Gyssens I.C., Dryden M., Kujath P., Nathwani D., Schaper N., Arvis P., Reimnitz P., Alder J., Hampel B.
Objectives: Major abscesses often need significant surgical intervention and antimicrobial therapy. Depending on their location, bacterial aetiology is variable or polymicrobial. Fluoroquinolones such as moxifloxacin (MXF) may offer advantages over other antimicrobial classes due to their broad spectrum and pharmacodynamic properties. MXF is approved in some European countries for the treatment of complicated skin and skin structure infections (cSSSIs) but due to limited data the approval does not include major abscesses. The RELIEF study was conducted to provide further data on the efficacy of MXF in specific cSSSI diagnoses. Data on major abscesses are presented.
Methods: This was a double-dummy, double-blind, randomised, controlled trial. Patients with a major abscess associated with extensive cellulitis and requiring antimicrobial therapy in addition to surgical incision and drainage, were stratified according to infection severity and randomised to IV/PO MXF 400 mg qd or IV piperacillin/tazobactam 4.0/0.5 g tds followed by PO amoxicillin/clavulanic acid (PIP/TAZ-AMC) 875/125 mg bd, for 721 days. The diagnosis of major abscess was documented by repeated pictures and confirmed by an independent data review committee. The primary efficacy variable was clinical response 1428 days after completion of therapy (test-of-cure, TOC). Non-inferiority of MXF to PIP/TAZ-AMC was demonstrated if the lower limit of the 95% CI was >-10%.
Results: A total of 354 patients (MXF=184, PIP/TAZ-AMC=170) with an abscess were randomised and 352 (MXF=183, PIP/TAZ-AMC=169) were valid for ITT/safety analyses. In the PP population (MXF=167, PIP/TAZ-AMC=153), 94 (56.3%) MXF- and 93 (60.8%) PIP/TAZ-AMC-treated patients had involvement of fascia, muscle or deeper tissues; fat was the deepest tissue involved in the remaining patients (MXF: 73, 43.7%; PIP/TAZ-AMC: 60, 39.2%). Among PP patients, 111 (34.7%) required local or extensive debridement in addition to surgical drainage. Mean (SD) lesion area was (MXF) 111 (141) cm2 and (PIP/TAZ-AMC) 110 (161) cm2. Abscesses of the rectal area (64.2%) and of the buttocks (36.1%) were most frequent. MXF was non-inferior to PIP/TAZ-AMC with respect to clinical response at TOC (Table). Bacteriological success rates were also comparable.
Conclusion: IV/PO MXF was non-inferior to IV PIP/TAZ-AMC in the patients with major abscesses. Based on these results, MXF can be considered a valuable option for the treatment of major abscesses.
Table: Clinical and bacteriological responses at TOC
|Session name:||19th European Congress of Clinical Microbiology and Infectious Diseases|
|Location:||Helsinki, Finland, 16 - 19 May 2009|
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