Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for 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. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients.

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Key information

Conditions

Infections, Gram-Positive Bacterial Abscess Bacterial Infections Bacterial Infections and Mycoses Burns Cellulitis Connective Tissue Diseases Gram-Positive Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Ulcer Wound Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Paradise Valley Hospital, 2400 E. 4th Street

National City, California, 91950, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 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 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

Treatment and study plan

Telavancin

Drug

Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days

Other names: TD-6424, VIBATIV

Vancomycin or antistaphylococcal penicillin

Drug

Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.

Primary outcomes

Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population

Time frame: 7 to 14 days following completion of antibiotic treatment
- Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary.
- Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit
- Indeterminate: Inability to determine outcome.

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study title

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)

Acronym: FAST2

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2004
First posted: Feb 13, 2004
Registry last updated: Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed