L-1512. Clinical Efficacy of Iclaprim in Complicated Skin and Skin Structure Infection (cSSSI): Results of Combined ASSIST Phase III Studies
Session: Poster Session: New Treatment Options in Skin and Soft Tissue Infections
Sunday, October 26, 2008: 12:00 AM
Room: Hall C
Background: The clinical efficacy of iclaprim (ICL) vs linezolid (LZD) was evaluated at the test-of-cure (TOC) visit using the combined data set of two essentially identical randomized, multicenter, double-blind Phase III clinical trials. Methods: Patients with cSSSI were treated for 10-14 days with IV ICL 0.8 mg/kg q 12 hours or IV linezolid (LZD) 600 mg q 12 hours.The efficacy endpoint was clinical cure rate at the TOC visit (7-14 days post-treatment) in the intent-to-treat (ITT), the per protocol (PP) and modified clinically evaluable (MCE) populations. Results: The ITT, PP and MCE populations comprised 991 (ICL: 500; LZD: 491), 823 (ICL: 415; LZD: 408) and 885 (ICL: 440; LZD: 445) patients, respectively. The distribution of the infection types was very similar in both treatment groups and encompassed: wound infections (19%), cellulitis (38%), major abscesses (25%), infected ulcers (11%) and first- or second-degree burns (10%).
Staphylococcus aureus (591 isolates) accounted for 69.9% of all Gram-positive pathogens and 39.9% were methicillin-resistant S. aureus (MRSA).
High clinical cure rates were observed in the ITT, PP and MCE populations and were 82.2% (95% CI = 78.6-85.5%), 92.3% (95% CI = 89.3-94.7%) and 87.0% (95% CI = 83.5-90.0%) respectively for ICL and 85.3% (95% CI = 81.9-88.4%), 97.8% (95% CI = 95.9-99.0%) and 89.7% (95% CI = 86.5-92.3%) respectively for LZD. Conclusions: ICL showed high efficacy in patients with cSSSI which was comparable to LZD. ICL could be an important new therapeutic option for treatment of cSSSI, especially those caused by MRSA.
Anthony Leighton1, Dan Sahm, PhD2, Dennis Stevens, MD, PhD, FIDSA3, Khalid Islam, PhD4, Maria Solonets4, Mark Jones, PhD5, Matthew Dryden6, Miriam O'Hare7, Paul Hadváry, PhD4, Wayne Dankner, MD, PhD8 and  M. Solonets,
Arpida AG Role(s): Employee, Received: Salary., (1)Arpida AG, (2)Focus Bio-Nova, Herndon, VA, (3)VA Medical Center, Boise, ID, (4)Arpida AG, Reinach, Switzerland, (5)Focus Bio-Inova, Inc., Herndon, VA, (6)Royal Hampshire County Hospital, (7)Micron Group Ltd, (8)PAREXEL International, Durham, NC