Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Summary

The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.

Timeline

Start

2003-08

Primary completion

2006-08

Completion

2006-08

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. NCT00062647 ↗

registry further statistical evaluation is not warranted owing to the small sample size. NCT00062647 ↗

Publications

• Stryjewski ME, Lentnek A, O'Riordan W, Pullman J, Tambyah PA, Miro JM, Fowler VG Jr, Barriere SL, Kitt MM, Corey GR. A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study. BMC Infect Dis. 2014 May 23;14:289. doi: 10.1186/1471-2334-14-289.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Telavancin	Other / unclassified	10 mg/kg	Intravenous
Comparator	Vancomycin	Other / unclassified	1 g	Intravenous
Comparator	cloxacillin	Other / unclassified	2 g	Intravenous
Comparator	nafcillin	Small molecule	2 g	Intravenous
Comparator	oxacillin	Small molecule	2 g	Intravenous

Indications