Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Infectious Disease, Hospital, Cosmetic, Gastrointestinal |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Gastroenterology, Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/18/2019 |
| Start Date: | June 2003 |
| End Date: | January 2004 |
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)
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.
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.
Inclusion Criteria:
- 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
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
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.
We found this trial at
1
site
Click here to add this to my saved trials
