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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Show All Outcome Measures

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
  Hide 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
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
  Hide More Information

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


No publications provided


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