Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (FAST2)

• ClinicalTrials.gov Identifier: NCT00077675
• Recruitment Status: Completed
• First Posted: February 13, 2004
• Results First Posted: January 11, 2010
• Last Update Posted: January 16, 2019
• Sponsor: Cumberland Pharmaceuticals
• Information provided by: Cumberland Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infections, Gram-positive Bacterial	Drug: Telavancin; Drug: vancomycin or antistaphylococcal penicillin	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Study Start Date: February 2004
• Actual Primary Completion Date: September 2004
• Actual Study Completion Date: September 2004

Arms and Interventions

Arm	Intervention/treatment
Experimental: Telavancin	Drug: Telavancin; Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days; Other Names: TD-6424; VIBATIV
Active Comparator: Standard of care for cSSSI; cSSSI - comlicated skin and skin structure infections	Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Paradise Valley Hospital, 2400 E. 4th Street

National City, California, United States, 91950

Sponsors and Collaborators

Cumberland Pharmaceuticals

Investigators

• Principal Investigator: G. Ralph Corey, MD; Duke University

More Information

• Responsible Party: Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
• ClinicalTrials.gov Identifier: NCT00077675
• Other Study ID Numbers: I6424-202b
• First Posted: February 13, 2004
• Results First Posted: January 11, 2010
• Last Update Posted: January 16, 2019
• Last Verified: January 2019

Keywords provided by Cumberland Pharmaceuticals:

Abscess; Burns; Cellulitis; Ulcer; Wound infections

Additional relevant MeSH terms:

Infections; Communicable Diseases; Gram-Positive Bacterial Infections; Disease Attributes; Pathologic Processes; Bacterial Infections; Bacterial Infections and Mycoses; Vancomycin; Penicillins; Telavancin; Anti-Bacterial Agents; Anti-Infective Agents