Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (FAST2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00077675|
Recruitment Status : Completed
First Posted : February 13, 2004
Results First Posted : January 11, 2010
Last Update Posted : May 18, 2010
|Condition or disease||Intervention/treatment||Phase|
|Infections, Gram-Positive Bacterial||Drug: Telavancin Drug: vancomycin or antistaphylococcal penicillin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram-Positive Skin and Skin Structure Infections (Gram Positive cSSSI)|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||September 2004|
|Actual Study Completion Date :||September 2004|
Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days
Active Comparator: Standard of care for cSSSI
cSSSI - comlicated skin and skin structure infections
Drug: vancomycin or antistaphylococcal penicillin
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.
- Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population [ Time Frame: 7 to 14 days following completion of antibiotic treatment ]
- 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 Test-of-Cure (TOC) visit
- Indeterminate: Inability to determine outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077675
|United States, California|
|Paradise Valley Hospital, 2400 E. 4th Street|
|National City, California, United States, 91950|
|Principal Investigator:||G. Ralph Corey, MD||Duke University|