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Antimicrobial Agents and Chemotherapy, July 2009, p. 2834-2840, Vol. 53, No. 7
0066-4804/09/$08.00+0     doi:10.1128/AAC.01383-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Multicenter, Randomized Study of the Efficacy and Safety of Intravenous Iclaprim in Complicated Skin and Skin Structure Infections{triangledown}

D. Krievins,1 R. Brandt,2 S. Hawser,2,{dagger} P. Hadvary,2 and K. Islam2*,{ddagger}

Stradini Clinical University Hospital, Riga, Latvia,1 Arpida Ltd., Reinach, Switzerland2

Received 15 October 2008/ Returned for modification 29 December 2008/ Accepted 29 April 2009

Iclaprim is a novel antibacterial agent that is currently in development for the treatment of complicated skin and skin structure infections (cSSSI). Iclaprim specifically and selectively inhibits bacterial dihydrofolate reductase, a critical enzyme in the bacterial folate pathway, and exhibits an extended spectrum of activity against various resistant pathogens, including methicillin (meticillin)-resistant Staphylococcus aureus (MRSA). The objective of this randomized, double-blind phase II study was to compare the efficacy and safety of iclaprim to those of vancomycin in patients with cSSSI. Patients were randomized to receive 0.8 mg iclaprim/kg of body weight, 1.6 mg/kg iclaprim, or 1 g vancomycin twice a day for 10 days. Clinical cure rates for the 0.8- and 1.6-mg/kg-iclaprim treatment groups were comparable to that for the vancomycin treatment group (26/28 patients [92.9%], 28/31 patients [90.3%], and 26/28 patients [92.9%], respectively). Iclaprim also showed high microbiological eradication rates. Iclaprim exhibited an eradication rate of 80% and 72% versus 59% observed with vancomycin for S. aureus, the pathogen most frequently isolated at baseline. Five MRSA cases were observed, four in the 0.8-mg/kg-iclaprim arm and one in the vancomycin arm, and all were both clinically and microbiologically cured. Iclaprim exhibited a safety profile similar to that of vancomycin, an established drug for the treatment of cSSSI. Results from this study indicate that iclaprim is a promising new therapy for the treatment of cSSSI, in particular those caused by S. aureus, including MRSA.

* Corresponding author. Mailing address: Arpida Ltd., Duggingerstrasse 23, 4153 Reinach, Switzerland. Phone: 41 (0)61 417 9660. Fax: 41 (0)61 417 9661. E-mail: khalid.islam{at}kiconsulting.ch

{triangledown} Published ahead of print on 4 May 2009.

{dagger} Present address: IHMA Europe Sàrl, Epalinges, Switzerland.

{ddagger} Present address: Ki Consulting AG, Reinach, Switzerland.

Antimicrobial Agents and Chemotherapy, July 2009, p. 2834-2840, Vol. 53, No. 7
0066-4804/09/$08.00+0     doi:10.1128/AAC.01383-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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