Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections

Phase 3 Completed 120 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to provide data documenting the efficacy of daptomycin in elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.

Timeline

Start: 2010-03
Primary completion: 2011-03
Completion: 2011-03

Publications

Background Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI; Daptomycin 98-01 and 99-01 Investigators. The safety and efficacy of daptomycin for the treatment of complicated skin and skin-structure infections. Clin Infect Dis. 2004 Jun 15;38(12):1673-81. doi: 10.1086/420818. Epub 2004 May 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daptomycin	Other / unclassified	4 mg/kg	Intravenous
Subject	Daptomycin	Other / unclassified	6 mg/kg	Intravenous
Comparator	FLOXACILLIN	Small molecule	2 g	Intravenous
Comparator	Vancomycin	Other / unclassified	1 g	Intravenous
Comparator	cloxacillin	Other / unclassified	2 g	Intravenous
Comparator	oxacillin	Small molecule	2 g	Intravenous

Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections

Summary

Timeline

Publications

Drugs

Indications