DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Pneumonia

Intervention: Telavancin (Drug); Vancomycin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Theravance Biopharma Antibiotics, Inc.

Official(s) and/or principal investigator(s):
G. Ralph Corey, MD, Principal Investigator, Affiliation: Duke University

Summary

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

Clinical Details

Official title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia With a Focus on Patients With Infections Due to Methicillin-Resistant Staphylococcus Aureus

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical Response

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Baystate Medical Center, Springfield, Massachusetts 01199, United States
Additional Information

Starting date: February 2005
Last updated: August 13, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017