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Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (ATTAIN2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00124020
First Posted: July 26, 2005
Last Update Posted: May 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Theravance Biopharma Antibiotics, Inc.
Results First Submitted: November 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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: 23 January 2005 to 02 May 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
14 patients (9 telavancin and 5 vancomycin) enrolled in the study but never started study treatment

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 every 12 hrs.

Participant Flow:   Overall Study
    Telavancin   Vancomycin
STARTED   377   380 
COMPLETED   289   289 
NOT COMPLETED   88   91 
Death                67                71 
Withdrawal by Subject                13                11 
Lost to Follow-up                5                8 
Other                1                1 
Transfer to another hospital                2                0 



  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 every 12 hrs.
Total Total of all reporting groups

Baseline Measures
   Telavancin   Vancomycin   Total 
Overall Participants Analyzed 
[Units: Participants]
 377   380   757 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   182   184   366 
>=65 years   195   196   391 
Age 
[Units: Years]
Mean (Standard Deviation)
 61  (17.8)   62  (18.0)   62  (17.9) 
Gender 
[Units: Participants]
     
Female   125   124   249 
Male   252   256   508 
Region of Enrollment 
[Units: Participants]
     
Argentina   20   19   39 
Australia   9   14   23 
Brazil   17   16   33 
Bulgaria   20   20   40 
Canada   3   10   13 
Chile   0   5   5 
China   27   37   64 
Croatia   2   2   4 
Czech Republic   3   1   4 
Estonia   0   1   1 
France   1   1   2 
Georgia   17   13   30 
Greece   1   1   2 
Israel   38   38   76 
Korea, Republic of   23   30   53 
Lebanon   5   4   9 
Lithuania   7   10   17 
Mexico   31   29   60 
Philippines   8   9   17 
Poland   6   4   10 
Romania   4   3   7 
Russian Federation   21   29   50 
Serbia   7   10   17 
Slovakia   6   6   12 
South Africa   7   3   10 
Spain   0   2   2 
Thailand   22   11   33 
Ukraine   12   6   18 
United States   60   46   106 
Diabetes Status 
[Units: Participants]
     
Diabetic   69   65   134 
Non-Diabetic   308   315   623 
History of Pneumonia 
[Units: Participants]
     
Prior history of pneumonia   37   45   82 
No prior history of pneumonia   340   335   675 
Ventilator Status 
[Units: Participants]
     
Ventilated   175   175   350 
Non-ventilated   202   205   407 


  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
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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
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  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, Inc
phone: 650-808-6132
e-mail: sbarriere@theravance.com


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

Responsible Party: Steven L. Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier: NCT00124020     History of Changes
Other Study ID Numbers: 0019
First Submitted: July 22, 2005
First Posted: July 26, 2005
Results First Submitted: November 3, 2009
Results First Posted: February 1, 2010
Last Update Posted: May 18, 2010