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Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01075178
First received: February 23, 2010
Last updated: March 18, 2011
Last verified: March 2011
Results First Received: January 28, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Severe Respiratory Syncytial Virus Infection

  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
Infants diagnosed with hemodynamically significant congenital heart disease who were less than 24 months of age when first dosed with palivizumab (CASES) were compared for the occurrence of serious adverse events over an 8-month chart review period with matched infants who did not receive palivizumab during the first 24 months of life (CONTROLS).

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
Palivizumab-treated Subjects (CASES) HSCHD infants, <2 yrs old at first dose of palivizumab
Non-palivizumab-treated Subjects (CONTROLS) HSCHD infants, <2 yrs old that did not receive palivizumab

Participant Flow for 2 periods

Period 1:   Subject Matching
    Palivizumab-treated Subjects (CASES)   Non-palivizumab-treated Subjects (CONTROLS)
STARTED   1148 [1]   1421 [1] 
COMPLETED   1018 [2]   1018 [2] 
NOT COMPLETED   130   403 
eligible but not matched                130                403 
[1] eligible for matching
[2] subjects matched

Period 2:   Subject Chart Review
    Palivizumab-treated Subjects (CASES)   Non-palivizumab-treated Subjects (CONTROLS)
STARTED   1018 [1]   1018 [1] 
COMPLETED   1009 [2]   1009 [2] 
NOT COMPLETED   9   9 
died before chart review period                0                2 
no data collected due to site closure                3                4 
matched partner excluded (reasons above)                6                3 
[1] subjects matched
[2] subjects in full analysis set



  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
Palivizumab-treated Subjects (CASES) HSCHD infants, <2 yrs old at first dose of palivizumab
Non-palivizumab-treated Subjects (CONTROLS) HSCHD infants, <2 yrs old that did not receive palivizumab
Total Total of all reporting groups

Baseline Measures
   Palivizumab-treated Subjects (CASES)   Non-palivizumab-treated Subjects (CONTROLS)   Total 
Overall Participants Analyzed 
[Units: Participants]
 1009   1009   2018 
Age 
[Units: Participants]
     
<=6 months   651   656   1307 
>6 months   358   353   711 
Age 
[Units: Months]
Mean (Standard Deviation)
 5.4  (4.91)   5.4  (5.05)   5.4  (4.98) 
Gender 
[Units: Participants]
     
Female   437   462   899 
Male   572   547   1119 
Region of Enrollment 
[Units: Participants]
     
France   188   211   399 
Slovenia   16   20   36 
Spain   284   170   454 
Poland   36   242   278 
Belgium   77   115   192 
Austria   96   53   149 
Norway   12   7   19 
Germany   97   90   187 
United Kingdom   92   59   151 
Italy   111   42   153 
Cardiac lesion 
[Units: Participants]
     
Cyanotic   488   487   975 
Acyanotic   521   522   1043 
Corrective cardiac surgery 
[Units: Participants]
     
None   484   485   969 
Partially corrected congenital heart disease   525   521   1046 
Fully corrected congenital heart disease   0   3   3 


  Outcome Measures
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1.  Primary:   Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death   [ Time Frame: 8-month chart review period in CASES and CONTROLS ]

2.  Primary:   Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection.   [ Time Frame: 8-month chart review period in CASES and CONTROLS ]

3.  Primary:   Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia   [ Time Frame: 8-month chart review period in CASES and CONTROLS ]

4.  Primary:   Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death   [ Time Frame: 8-month chart review period in CASES and CONTROLS ]


  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
Only serious adverse events of infection and arrhythmia as well as deaths were collected in this study. The criterion for non-inferiority was not met for death, most likely because the reported mortality rates were lower than expected in both groups.


  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 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.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110



Responsible Party: Andrew L. Campbell, M.D., Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT01075178     History of Changes
Other Study ID Numbers: M03-681
Study First Received: February 23, 2010
Results First Received: January 28, 2011
Last Updated: March 18, 2011
Health Authority: European Union: European Medicines Agency