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

Phase 2

Completed

• Conditions: Cellulitis; Abscess; Burns; Infections, Gram-Positive Bacterial; Ulcer; Wound Infections
• Interventions: Drug: Vancomycin or antistaphylococcal penicillin; Drug: Telavancin

• Registration Number: NCT00061633
• Lead Sponsor: Cumberland Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-05-30
• Study First Submitted QC: 2003-05-30
• Study Start: 2003-06
• Study First Posted: 2003-06-02
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Results First Submitted: 2009-12-02
• Results First Submitted QC: 2009-12-02
• Results First Posted: 2010-01-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care for cSSSI	Vancomycin or antistaphylococcal penicillin	cSSSI - complicated skin and skin structure infections
Telavancin	Telavancin	-

Primary Outcome Measures

Name	Time	Method
Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population	7-14 days following end 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 the Test-of-Cure (TOC) visit.; * Indeterminate: Inability to determine outcome.

Trial Locations

Locations (1)

eStudy Site, 3450 Bonita Road, Ste 201; 🇺🇸 Chula Vista, California, United States