Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1035 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-05-31

Brief Summary

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Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.

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Detailed Description

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Conditions

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Staphylococcal Skin Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Telavancin

Group Type EXPERIMENTAL

Telavancin

Intervention Type DRUG

Telavancin 10 mg/kg/day, IV for up to 14 days.

Vancomycin

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.

Interventions

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Telavancin

Telavancin 10 mg/kg/day, IV for up to 14 days.

Intervention Type DRUG

Vancomycin

Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.

Intervention Type DRUG

Other Intervention Names

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VIBATIV TD-6424

Eligibility Criteria

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Inclusion Criteria

* Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either suspected or confirmed 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 7 days of intravenous antibiotic treatment.

* Received more than 24 hours of potentially effective systemic (IV/IM or PO) antibiotic therapy
* 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