Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections

Summary

multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.

Timeline

Start

2007-01

Primary completion

2007-09

Completion

2007-09

Outcome

Missed primary endpoint

paper Overall, clinical success rates were 75.0% (36/48) for daptomycin and 87.5% (42/48) for comparator (95% confidence interval for the difference: -27.9, 2.9). PMID 18662172 ↗

paper Although the differences were not statistically significant, clinical success rates for comparator were higher than for daptomycin. PMID 18662172 ↗

Publications

• Katz DE, Lindfield KC, Steenbergen JN, Benziger DP, Blackerby KJ, Knapp AG, Martone WJ. A pilot study of high-dose short duration daptomycin for the treatment of patients with complicated skin and skin structure infections caused by gram-positive bacteria. Int J Clin Pract. 2008 Sep;62(9):1455-64. doi: 10.1111/j.1742-1241.2008.01854.x. Epub 2008 Jul 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daptomycin	Other / unclassified	10 mg/kg	Intravenous
Subject	Vancomycin	Other / unclassified	1 g	—

Indications

No indication recorded.