Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (ATTAIN1)
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ClinicalTrials.gov Identifier: NCT00107952 |
Recruitment Status
:
Completed
First Posted
: April 12, 2005
Results First Posted
: December 8, 2009
Last Update Posted
: August 18, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bacterial Pneumonia | Drug: Telavancin Drug: Vancomycin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 761 participants |
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 |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | July 2007 |
Actual Study Completion Date : | July 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Telavancin |
Drug: Telavancin
Telavancin 10 mg/kg/day IV for up to 21 days.
Other Names:
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Active Comparator: Vancomycin |
Drug: Vancomycin
Vancomycin 1 Gm IV q 12 hrs for up to 21 days
|
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107952
United States, Massachusetts | |
Baystate Medical Center | |
Springfield, Massachusetts, United States, 01199 |
Principal Investigator: | G. Ralph Corey, MD | Duke University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
First Posted: | April 12, 2005 Key Record Dates |
Results First Posted: | December 8, 2009 |
Last Update Posted: | August 18, 2014 |
Last Verified: | August 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 |