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

In brief

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.

Key facts

Study ID: NCT00077675
Run by: Cumberland Pharmaceuticals
People needed: 201
Starts: 2004-02-01
Expected to finish: 2004-09-01
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 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

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 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

Where it is running

Paradise Valley Hospital, 2400 E. 4th Street — National City, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.