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

NCT ID: NCT00061633

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2004-01-31

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.

Conditions

Infections, Gram-Positive Bacterial; Abscess; Burns; Cellulitis; Ulcer; Wound Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Telavancin

Group Type: EXPERIMENTAL

Telavancin

Intervention Type: DRUG

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

Standard of care for cSSSI

cSSSI - complicated skin and skin structure infections

Group Type: ACTIVE_COMPARATOR

Vancomycin or antistaphylococcal penicillin

Intervention Type: 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.

Interventions

Telavancin

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

VIBATIV; TD-6424

Eligibility Criteria

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

Exclusion Criteria

• deep/extensive cellulitis
• wound infections
• Patients must be expected to require at least 4 days of intravenous antibiotic treatment

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Theravance, Inc.

Principal Investigators

G. Ralph Corey, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

eStudy Site, 3450 Bonita Road, Ste 201

Chula Vista, California, United States

Countries

United States

Other Identifiers

I6424-202a

Identifier Type: -

Identifier Source: org_study_id