Clinical efficacy of iclaprim in complicated skin and skin structure infection: preliminary results from the ASSIST-2 clinical trial

Abstract number: P545

Dryden M., O'Hare O., Sidarous E., Hadvary P., Islam K.

Objective: To compare the clinical efficacy of iclaprim (ICL) with that of linezolid (LZD) at the test-of-cure (TOC) visit in the ASSIST-2 (Arpida's Skin and Skin Structure Infection Study-2), randomised, multicentre, double-blind, Phase III clinical trial.

Methods: Patients with complicated skin and skin structure infection (cSSSI) were randomised to one of two treatment arms: intravenous ICL 0.8 mg/kg q 12 hours or intravenous linezolid (LZD) 600 mg q 12 hours and received 10–14 days treatment. Clinical cure rate at the TOC visit in the intent-to-treat (ITT) and the per protocol (PP) populations was the primary efficacy endpoint for this study. The non-inferiority margin assigned was <12.5% for the 95% confidence interval (CI) for treatment difference.

Results: The ITT population comprised 494 patients (ICL: 251; LZD: 243), with 404 of these patients eligible for the per-protocol (PP) population (ICL: 205; LZD: 195). The distribution of cSSSIs at baseline was: wound infection (45%), major abscess (30%), cellulitis (28%), infected ulcers (8%), and infected burns (7%), with little variation between the treatment groups. The most commonly isolated baseline pathogen was Staphylococcus aureus (309 isolates), accounting for 63% of all Gram-positive pathogens (ICL: 59%; LZD: 66%). Meticillin-resistant S. aureus (MRSA) represented 50% of all S. aureus strains (ICL: 50%; LZD: 50%). Clinical cure rates were comparable between treatment groups in the ITT population (ICL: 81.3%, 95% CI = 75.9%-85.9%; LZD: 81.9%, 95% CI = 76.5%-86.5%). In the PP population there was a small numerical difference between the two groups (ICL: 90.0%; LZD: 96.9%).However, the number of patients receiving prohibited antibiotics and being therefore excluded from the PP population was much higher in the linezolid group. In a clinically evaluable population including the patients taking prohibited antibacterial agents during the trial, the clinical cure rates were comparable (ICL: 84.7%, 95% CI = 79.3%-89.2%; LZD: 86.6%, 95% CI = 81.4%-90.9%). The 95% CI for treatment difference was -8.83% to 4.95% in the population.

Conclusions: ICL shows high efficacy in patients with cSSSI as evidenced by the high cure rates. ICL achieved the pre-specfified primary endpoint of non-inferior clinical cure rate when compared with LZD. ICL could be a useful addition to the antibacterial armamentarium for cSSSI.

Session Details

Date: 19/04/2008
Time: 00:00-00:00
Session name: 18th European Congress of Clinical Microbiology and Infectious Diseases
Location: Barcelona, Spain
Presentation type:
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