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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:
ClinicalTrials.gov Identifier:
NCT00107952
First Posted: April 12, 2005
Last Update Posted: August 18, 2014
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: 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 
Overall Participants Analyzed 
[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
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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
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


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 Submitted: April 11, 2005
First Posted: April 12, 2005
Results First Submitted: November 3, 2009
Results First Posted: December 8, 2009
Last Update Posted: August 18, 2014