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: Infections, Gram-positive Bacterial
• Interventions: Drug: Telavancin; Drug: vancomycin or antistaphylococcal penicillin

• Registration Number: NCT00077675
• Lead Sponsor: Cumberland Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2004-02-10
• Study First Submitted QC: 2004-02-12
• Study First Posted: 2004-02-13
• Primary Completion: 2004-09
• Study Completion: 2004-09
• 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: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Paradise Valley Hospital, 2400 E. 4th Street; 🇺🇸 National City, California, United States