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)
Overview
- Phase
- Phase 2
- Intervention
- Telavancin
- Conditions
- Infections, Gram-positive Bacterial
- Sponsor
- Cumberland Pharmaceuticals
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism
- •major abscess requiring surgical incision and drainage
- •infected burn (see exclusion criteria for important qualifications)
- •deep/extensive cellulitis
- •infected ulcer (see exclusion criteria for important qualifications)
- •wound infection
- •Patients must be expected to require at least 4 days of intravenous (IV) antibiotic treatment
Exclusion Criteria
- •Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for \> 24 hours within 7 days prior to the first dose of study drug unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days)
- •Burns involving \> 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis
Arms & Interventions
Telavancin
Intervention: Telavancin
Standard of care for cSSSI
cSSSI - comlicated skin and skin structure infections
Intervention: vancomycin or antistaphylococcal penicillin
Outcomes
Primary Outcomes
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.