A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia

This study has been terminated.
(Trial terminated early per business decision)
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01110421
First received: April 15, 2010
Last updated: July 2, 2014
Last verified: July 2014
Results First Received: May 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Pneumonia, Bacterial
Community-Acquired Infections
Nosocomial Infection
Pneumonia, Ventilator-Associated
Interventions: Drug: Cefepime placebo
Drug: Cefepime
Drug: Doripenem
Drug: Doripenem placebo
Drug: Amoxicillin/clavulanate potassium

  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
No text entered.

Reporting Groups
  Description
Doripenem Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
Cefepime Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.

Participant Flow:   Overall Study
    Doripenem     Cefepime  
STARTED     5     2  
COMPLETED     5 [1]   2  
NOT COMPLETED     0     0  
[1] Includes 1 participant who discontinued study drug due to an adverse event of empyema on Days 9-13.



  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 Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
Cefepime Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
Total Total of all reporting groups

Baseline Measures
    Doripenem     Cefepime     Total  
Number of Participants  
[units: participants]
  5     2     7  
Age  
[units: participants]
     
<=18 years     5     2     7  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  5.2  ± 2.49     4.5  ± 0.71     5  ± 2.08  
Age, Customized  
[units: participants]
     
3 months to <2 years     0     0     0  
2 to <6 years     3     2     5  
6 to <12 years     2     0     2  
12 to <18 years     0     0     0  
Gender  
[units: participants]
     
Female     0     1     1  
Male     5     1     6  



  Outcome Measures
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1.  Primary:   The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit   [ Time Frame: TOC (7 to 14 days after the last dose of study medication therapy) ]

2.  Secondary:   The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit   [ Time Frame: EIV (within 24 hours after completion of the last dose of IV study medication therapy) ]

3.  Secondary:   The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit   [ Time Frame: LFU (28 to 42 days after the last dose of study medication therapy) ]

4.  Secondary:   The Number of Participants With Favorable Per-participant Microbiological Response Rate   [ Time Frame: EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy) ]

5.  Secondary:   Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit   [ Time Frame: EIV (within 24 hours after completion of the last dose of IV study medication therapy) ]

6.  Secondary:   Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit   [ Time Frame: TOC (7 to 14 days after the last dose of study medication therapy) ]

7.  Secondary:   Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit   [ Time Frame: LFU (28 to 42 days after the last dose of study medication therapy) ]


  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
This study was terminated early due to business reasons and not related to safety concerns or issues. As such, the limited enrollment precludes a meaningful conclusion about the efficacy and safety of doripenem compared with cefepime.


  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: Therapeutic Areas Director
Organization: Janssen R&D US
e-mail: ClinicalTrialDisclosure@its.jnj.com


No publications provided


Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01110421     History of Changes
Other Study ID Numbers: CR016975, DORIPED3003, 2009-016069-27
Study First Received: April 15, 2010
Results First Received: May 30, 2014
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Latvia: State Agency of Medicines
Ukraine: State Pharmacological Center - Ministry of Health
United States: Federal Government