An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PriCara, Unit of Ortho-McNeil, Inc.
ClinicalTrials.gov Identifier:
NCT00502801
First received: July 16, 2007
Last updated: September 19, 2013
Last verified: September 2013
Results First Received: February 13, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pneumonia
Bacterial Pneumonia
Ventilator-Associated Pneumonia
Infections, Nosocomial
Intervention: Drug: doripenem

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two enrolled subjects didn’t take study medication and weren’t qualified for safety population.

Reporting Groups
  Description
Doripenem 1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment

Participant Flow for 2 periods

Period 1:   Treatment Period
    Doripenem  
STARTED     183  
COMPLETED     129  
NOT COMPLETED     54  
Withdrawal by Subject                 3  
Adverse Event                 7  
Death                 14  
OTHER                 30  

Period 2:   End of Therapy to Test of Cure
    Doripenem  
STARTED     129  
COMPLETED     121  
NOT COMPLETED     8  
Withdrawal by Subject                 1  
Lost to Follow-up                 2  
Death                 3  
OTHER                 2  



  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
Doripenem 1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment

Baseline Measures
    Doripenem  
Number of Participants  
[units: participants]
  183  
Age  
[units: years]
Mean ± Standard Deviation
  56  ± 20.23  
Gender  
[units: participants]
 
Female     71  
Male     112  
Region of Enrollment  
[units: participants]
 
ARGENTINA     4  
CANADA     6  
CHILE     9  
CROATIA     21  
FRANCE     6  
INDIA     10  
RUSSIA     2  
UKRAINE     5  
USA     120  
race  
[units: participants]
 
AMERICAN INDIAN OR ALASKA     2  
ASIAN     14  
BLACK OR AFRICAN AMERICAN     14  
OTHER, SPECIFY     2  
WHITE     151  
ethnicity  
[units: participants]
 
HISPANIC OR LATINO     20  
NOT HISPANIC OR LATINO     158  
OTHER     5  
BMI  
[units: kg/m^2]
Mean ± Standard Deviation
  27.4  ± 8.63  



  Outcome Measures
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1.  Primary:   Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.   [ Time Frame: 5 to 21 days after the last dose of study therapy, or at early termination. ]

2.  Secondary:   Clinical Response Rates at the Late Follow-up Assessment.   [ Time Frame: 28 to 35 days after last dose of study therapy ]


  Serious Adverse Events


  Other Adverse Events


  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 less than or equal to 60 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.


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.  


Results Point of Contact:  
Name/Title: Vice President, Data Generation
Organization: Janssen Scientific Affairs, LLC
phone: 908 927-2943


No publications provided


Responsible Party: PriCara, Unit of Ortho-McNeil, Inc.
ClinicalTrials.gov Identifier: NCT00502801     History of Changes
Other Study ID Numbers: CR012931, DORIINI2002
Study First Received: July 16, 2007
Results First Received: February 13, 2013
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration