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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 7–21 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 14–28 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

 MXFPIP/TAZ95% CI
 n/N (%)n/N (%) 
Clinical response
Per-protocol160/167 (95.8)147/153 (96.1)-4.2, 4.5
MBV119/125 (95.2)113/117 (96.6)-5.5, 4.3
ITT163/183 (89.1)151/169 (89.3)-5.6, 7.2
ITT with organisms122/135 (90.4)114/125 (91.2)-5.6, 8.1
Bacteriological response
MBV117/125 (93.6)113/117 (96.6)-7.5, 3.1
ITT with organisms119/135 (88.1)114/125 (91.2)-8.0, 6.3
Bacteriological response by key organism
Staphylococcus aureus   
  Methicillin-susceptible65/69 (94.2)66/67 (98.5)0.366
  Methicillin-resistant4/4 (100)2/2 (100)-
Escherichia coli   
  non-ESBL28/31 (90.3)22/23 (95.7)0.628
  ESBL3/3 (100)0-
Enterococcus faecalis13/14 (92.9)9/10 (90.0)1.000
Streptococcus pyogenes23/23 (100)15/17 (88.2)0.174
Bacteroides fragilis16/20 (80.0)9/11 (81.8)1.000
Fisher's exact test. MBV: microbiologically valid.

Session Details

Date: 16/05/2009
Time: 00:00-00:00
Session name: 19th European Congress of Clinical Microbiology and Infectious Diseases
Subject:
Location: Helsinki, Finland, 16 - 19 May 2009
Presentation type:
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