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

Cumberland Pharmaceuticals771 enrolled

Overview

Study 0019 (NCT00124020) 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

771

Conditions

Bacterial Pneumonia

Interventions

TelavancinDRUG

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

VancomycinDRUG

Vancomycin 1 Gm administered every 12 hrs IV 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)

Sheba Medical Center, Infectious Disease Unit

Tel Litwinsky, Israel

Outcomes

Primary Outcomes

Clinical Response

Clinical Response: Categorical (Cured, Failed or Indeterminate) * Failure - 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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