Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (FAST)
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|ClinicalTrials.gov Identifier: NCT00061633|
Recruitment Status : Completed
First Posted : June 2, 2003
Results First Posted : January 11, 2010
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infections, Gram-Positive Bacterial Abscess Burns Cellulitis Ulcer Wound Infections||Drug: Telavancin Drug: Vancomycin or antistaphylococcal penicillin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||169 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, 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 :||June 2003|
|Actual Primary Completion Date :||January 2004|
|Actual Study Completion Date :||January 2004|
Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days
Active Comparator: Standard of care for cSSSI
cSSSI - complicated 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: 7-14 days following end 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 the 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): NCT00061633
|United States, California|
|eStudy Site, 3450 Bonita Road, Ste 201|
|Chula Vista, California, United States, 91910|
|Principal Investigator:||G. Ralph Corey, MD||Duke University|