Status:
COMPLETED
Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Lead Sponsor:
Cumberland Pharmaceuticals
Conditions:
Infections, Gram-positive Bacterial
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT00077675
Start Date
February 1 2004
End Date
September 1 2004
Last Update
January 16 2019
Active Locations (1)
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1
Paradise Valley Hospital, 2400 E. 4th Street
National City, California, United States, 91950