Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

761 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-07-31

Brief Summary

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Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.

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Detailed Description

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Conditions

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Bacterial Pneumonia

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 21 days.

Vancomycin

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Vancomycin 1 Gm IV q 12 hrs for up to 21 days

Interventions

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Telavancin

Telavancin 10 mg/kg/day IV for up to 21 days.

Intervention Type DRUG

Vancomycin

Vancomycin 1 Gm IV q 12 hrs for up to 21 days

Intervention Type DRUG

Other Intervention Names

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TD-6424 VIBATIV

Eligibility Criteria

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Inclusion Criteria

* Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration.

Exclusion Criteria

* Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No