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

Infections, Gram-positive Bacterial Clinical Trial

— FAST2  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077675
• Other study ID #: I6424-202b
• Status: Completed
• Phase: Phase 2
• Start date: February 2004
• Est. completion date: September 2004

Study information

• Verified date: January 2019
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Gram-Positive Bacterial Infections
• Infection
• Infections, Gram-positive Bacterial

Intervention

Drug:
• Telavancin
Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days
• vancomycin or antistaphylococcal penicillin
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.

Locations

Country	Name	City	State
United States	Paradise Valley Hospital, 2400 E. 4th Street	National City	California

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population	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.	7 to 14 days following completion of antibiotic treatment