Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (FAST)

Cumberland Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Infections, Gram-Positive Bacterial

Ulcer

Cellulitis

Wound Infections

Burns

Abscess

Treatments

Drug: Vancomycin or antistaphylococcal penicillin

Drug: Telavancin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00061633

I6424-202a

Details and patient eligibility

About

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.

Enrollment

169 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.