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

This study has been completed.
Sponsor:
Information provided by:
Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier:
NCT00107952
First received: April 11, 2005
Last updated: August 13, 2014
Last verified: August 2014
Results First Received: November 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bacterial Pneumonia
Interventions: Drug: Telavancin
Drug: Vancomycin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment Period: 08Feb05 to 11Jul07

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Telavancin Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
Vancomycin Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.

Participant Flow:   Overall Study
    Telavancin     Vancomycin  
STARTED     381     380  
COMPLETED     286     299  
NOT COMPLETED     95     81  
Death                 75                 61  
Lost to Follow-up                 0                 3  
Withdrawal by Subject                 9                 6  
Other                 2                 5  
Never received study treatment                 9                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telavancin Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
Vancomycin Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
Total Total of all reporting groups

Baseline Measures
    Telavancin     Vancomycin     Total  
Number of Participants  
[units: participants]
  372     374     746  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     170     162     332  
>=65 years     202     212     414  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 19.2     64  ± 17.3     64  ± 18.3  
Gender  
[units: participants]
     
Female     137     161     298  
Male     235     213     448  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     78     66     144  
Not Hispanic or Latino     294     308     602  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     2     0     2  
Asian     91     87     178  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     10     14     24  
White     267     272     539  
More than one race     1     1     2  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
Argentina     24     24     48  
Australia     20     25     45  
Belgium     3     5     8  
Brazil     12     14     26  
Canada     14     10     24  
Chile     9     5     14  
Croatia     28     31     59  
Czech Republic     0     1     1  
France     15     17     32  
Greece     4     8     12  
India     44     41     85  
Israel     25     24     49  
Italy     3     4     7  
Malaysia     13     7     20  
Malta     2     1     3  
Peru     2     3     5  
Poland     0     2     2  
South Africa     2     2     4  
Taiwan     29     34     63  
Turkey     2     1     3  
United Kingdom     4     2     6  
United States     117     113     230  
Diabetes Status  
[units: Participants]
     
Diabetic     100     100     200  
Non-Diabetic     272     274     546  
History of Pneumonia  
[units: participants]
     
Prior history of pneumonia     62     53     115  
No prior history of pneumonia     310     321     631  
Ventilator Status  
[units: Participants]
     
Ventilated     170     171     341  
Non-ventilated     202     203     405  



  Outcome Measures

1.  Primary:   Clinical Response   [ Time Frame: 7 - 14 days following end of antibiotic treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs
Organization: Theravance Biopharma Antibiotics, Inc.
phone: 650-808-6132
e-mail: sbarriere@theravance.com


No publications provided by Theravance Biopharma Antibiotics, Inc.

Publications automatically indexed to this study:

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
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Belgium: Ministry of Social Affairs, Public Health and the Environment
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Chile: Instituto de Salud Pública de Chile
Croatia: Agency for Medicinal Product and Medical Devices
Croatia: Ethics Committee
Croatia: Ministry of Health and Social Care
Croatia: Ministry of Science, Education and Sports
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Haute Autorité de Santé Transparency Commission
France: Institutional Ethical Committee
France: Ministry of Health
France: National Consultative Ethics Committee for Health and Life Sciences
Greece: Ethics Committee
Greece: Ministry of Health and Welfare
Greece: National Organization of Medicines
India: Indian Council of Medical Research
Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Israel: Ministry of Health
Israel: The Israel National Institute for Health Policy Research and Health Services Research
Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Malaysia: Ministry of Health
Malta: Medicines Authority
Peru: Ethics Committee
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Ministry of Health
Poland: Ethics Committee
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Africa: Department of Health
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs
Turkey: Ministry of Health
United Kingdom: Department of Health
United Kingdom: Food Standards Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration