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

Cumberland Pharmaceuticals761 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

761

Conditions

Bacterial Pneumonia

Interventions

TelavancinDRUG

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

VancomycinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Baystate Medical Center

Springfield, Massachusetts, United States

Outcomes

Primary Outcomes

Clinical Response

Clinical Response: Categorical (Cured, Failed or Indeterminate) * Failure is at least one of the following: Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy; Termination of study med due to "lack of efficacy"; Death on or after Day 3 attributable to primary infection * Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress. * Indeterminate: Inability to determine outcome

Time frame: 7 - 14 days following end of antibiotic treatment

Data from ClinicalTrials.gov

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