Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
169
Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days
Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.
eStudy Site, 3450 Bonita Road, Ste 201
Chula Vista, California, United States
Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
* Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary. * Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to the Test-of-Cure (TOC) visit. * Indeterminate: Inability to determine outcome.
Time frame: 7-14 days following end of antibiotic treatment
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