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

NCT ID: NCT00077675

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2004-09-30

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.

Conditions

Infections, Gram-positive Bacterial

Study Design

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

Study Groups

Telavancin

Group Type: EXPERIMENTAL

Telavancin

Intervention Type: DRUG

Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days

Standard of care for cSSSI

cSSSI - comlicated 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, amended to 10 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

TD-6424; VIBATIV

Eligibility 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

Exclusion Criteria

• deep/extensive cellulitis
• wound infection
• Patients must be expected to require at least 4 days of intravenous (IV) 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 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

• 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

Paradise Valley Hospital, 2400 E. 4th Street

National City, California, United States

Countries

United States

Other Identifiers

I6424-202b

Identifier Type: -

Identifier Source: org_study_id