Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Completed · Phase 2
Conditions studied: Infections, Gram-Positive Bacterial, Abscess, Burns, Cellulitis, Ulcer, Wound Infections
In brief
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.
Key facts
- Study ID
- NCT00061633
- Run by
- Cumberland Pharmaceuticals
- People needed
- 169
- Starts
- 2003-06-01
- Expected to finish
- 2004-01-01
- Last updated by the study team
- 2019-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have a diagnosis of one of the following complicated skin and skin structure infections with either a suspected or confirmed Gram positive organism as the major cause of the infection:
- 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 infections
- Patients must be expected to require at least 4 days of intravenous antibiotic treatment
You may not qualify if…
- Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for > 24 hours within 7 days prior to the first dose of study medication 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.
Where it is running
- eStudy Site, 3450 Bonita Road, Ste 201 — Chula Vista, California, United States
Full record on ClinicalTrials.gov
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