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

Phase 3

Completed

• Conditions: Bacterial Pneumonia
• Interventions: Drug: Telavancin; Drug: Vancomycin

• Registration Number: NCT00107952
• Lead Sponsor: Cumberland Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-04-11
• Study First Submitted QC: 2005-04-11
• Study First Posted: 2005-04-12
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Results First Submitted: 2009-11-03
• Results First Submitted QC: 2009-11-03
• Results First Posted: 2009-12-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 761

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telavancin	Telavancin	-
Vancomycin	Vancomycin	-

Primary Outcome Measures

Name	Time	Method
Clinical Response	7 - 14 days following end of antibiotic treatment	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

Trial Locations

Locations (1)

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States