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

Purpose

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

Condition	Intervention	Phase
Bacterial Pneumonia	Drug: Telavancin Drug: Vancomycin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Health Facilities MRSA Pneumonia

Drug Information available for: Vancomycin Vancomycin hydrochloride Telavancin Telavancin hydrochloride

U.S. FDA Resources

Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:

Clinical Response [ Time Frame: 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


Enrollment:	761
Study Start Date:	February 2005
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Telavancin	Drug: Telavancin Telavancin 10 mg/kg/day IV for up to 21 days. Other Names: TD-6424 VIBATIV
Active Comparator: Vancomycin	Drug: Vancomycin Vancomycin 1 Gm IV q 12 hrs for up to 21 days

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107952

Locations


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

Sponsors and Collaborators

Theravance Biopharma Antibiotics, Inc.

Investigators


Principal Investigator:	G. Ralph Corey, MD	Duke University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Smart JI, Corey GR, Stryjewski ME, Wang W, Barriere SL. Assessment of Minimum Inhibitory Concentrations of Telavancin by Revised Broth Microdilution Method in Phase 3 Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia Clinical Isolates. Infect Dis Ther. 2016 Dec;5(4):535-544. Epub 2016 Oct 7.

Barriere SL, Stryjewski ME, Corey GR, Genter FC, Rubinstein E. Effect of vancomycin serum trough levels on outcomes in patients with nosocomial pneumonia due to Staphylococcus aureus: a retrospective, post hoc, subgroup analysis of the Phase 3 ATTAIN studies. BMC Infect Dis. 2014 Apr 4;14:183. doi: 10.1186/1471-2334-14-183.


Responsible Party:	Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier:	NCT00107952 History of Changes
Other Study ID Numbers:	0015
Study First Received:	April 11, 2005
Results First Received:	November 3, 2009
Last Updated:	August 13, 2014

Keywords provided by Theravance Biopharma Antibiotics, Inc.:


Nosocomial pneumonia MRSA

Additional relevant MeSH terms:


Pneumonia Staphylococcal Infections Pneumonia, Bacterial Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Gram-Positive Bacterial Infections	Bacterial Infections Vancomycin Methicillin Telavancin Anti-Bacterial Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 21, 2017

Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (ATTAIN1)