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To Compare Safety and Efficacy of Doripenem Versus Imipenem-Cilastatin in Patients With Ventilator-Associated Pneumonia

This study has been terminated.
(Observed lower cure rates and higher mortality rates in one of the treatment groups.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00589693
First Posted: January 10, 2008
Last Update Posted: December 28, 2012
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 (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Results First Submitted: June 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ventilator-Associated Pneumonia
Interventions: Drug: Doripenem
Drug: Imipenem-Cilastatin
Drug: Placebo

  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
274 enrolled patients were randomnly assigned to the 127 study centers. 524 patients were to be enrolled, however as the study was terminated early only 274 patients were actually enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 274 randomized patients, 41 patients were excluded (as their sites were GCP Non-Compliant) and 6 patients were not treated. Treated patients=227 (115 doripenem and 112 imipenem-cilastatin).

Reporting Groups
  Description
Doripenem 1 g 4-hour infusion intravenously every 8 hour for 7 days
Imipenem-cilastatin 1 g 1-hour infusion intravenously every 8 hour for 10 days

Participant Flow:   Overall Study
    Doripenem   Imipenem-cilastatin
STARTED   115   112 
COMPLETED   71   83 
NOT COMPLETED   44   29 
randomized in error                12                6 
Adverse Event                4                4 
Death                26                16 
Lack of Efficacy                0                1 
Lost to Follow-up                1                0 
Physician Decision                0                1 
Protocol Violation                1                1 



  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 1 g 4-hour infusion intravenously every 8 hour for 7 days
Imipenem-cilastatin 1 g 1-hour infusion intravenously every 8 hour for 10 days
Total Total of all reporting groups

Baseline Measures
   Doripenem   Imipenem-cilastatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 115   112   227 
Age 
[Units: Participants]
     
<=18 years   0   1   1 
Between 18 and 65 years   72   72   144 
>=65 years   43   39   82 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.5  (16.53)   54.6  (18.46)   56.1  (17.53) 
Gender 
[Units: Participants]
     
Female   43   37   80 
Male   72   75   147 
Region Enroll 
[Units: Participants]
     
EUROPE   69   71   140 
NORTH AMERICA   16   12   28 
REST OF WORLD   9   6   15 
SOUTH AMERICA   21   23   44 


  Outcome Measures
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1.  Primary:   Clinical Cure Rate at the End-of-treatment (EOT) Visit   [ Time Frame: End-of-treatment (Day 10 or Day 11) ]

2.  Secondary:   Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline   [ Time Frame: End-of-treatment (Day 10 or Day 11) ]

3.  Secondary:   Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline   [ Time Frame: End-of-treatment (Day 10 or Day 11) ]

4.  Secondary:   Number of Patients Who Had Emergence of P. Aeruginosa Resistance   [ Time Frame: Up to 6 weeks ]

5.  Secondary:   28-day All-cause Mortality Rate   [ Time Frame: Up to 28 days ]


  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
41 patients (21 doripenem, 20 imipenem-cilastatin) were enrolled at 5 sites that were found to be Good Clinical Practice non-compliant and were excluded from the primary efficacy and safety analyses.


  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.


Results Point of Contact:  
Name/Title: Sr Director Clinical Development
Organization: Janssen R&D US
phone: 1 510 248-2310


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

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00589693     History of Changes
Other Study ID Numbers: CR014038
DORINOS3008 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
2007-004646-33 ( EudraCT Number )
First Submitted: December 21, 2007
First Posted: January 10, 2008
Results First Submitted: June 13, 2012
Results First Posted: July 18, 2012
Last Update Posted: December 28, 2012