A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America

This study has been completed.
Sponsor:
Collaborator:
Fundasamin (Argentina)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01297504
First received: February 15, 2011
Last updated: September 19, 2014
Last verified: September 2014
Results First Received: August 22, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Palivizumab Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.

Participant Flow:   Overall Study
    Palivizumab  
STARTED     464  
Participants Studied     458 [1]
COMPLETED     397  
NOT COMPLETED     67  
Invalid Consent                 1  
Received Palivizumab in Previous Season                 1  
No Study Visits                 4  
Death                 3  
Lost to Follow-up                 43  
Withdrawal by Subject                 9  
Site Closure                 3  
Protocol Violation                 3  
[1] Six participants were eliminated due to invalid consent, previous palivizumab or no study visits



  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.
Participants Studied

Reporting Groups
  Description
Palivizumab Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.

Baseline Measures
    Palivizumab  
Number of Participants  
[units: participants]
  458  
Age  
[units: days]
Median ( Inter-Quartile Range )
  55  
  ( 31 to 99 )  
Gender  
[units: participants]
 
Female     219  
Male     239  
Region of Enrollment  
[units: participants]
 
Mexico     100  
Ecuador     7  
Argentina     149  
Uruguay     10  
Peru     13  
Chile     32  
Colombia     147  
Study-Specific Measure  
[units: g]
Mean ± Standard Deviation
  1344.6  ± 460.5  



  Outcome Measures
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1.  Primary:   Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection   [ Time Frame: Baseline ]

2.  Primary:   Distribution of Comorbidities in Study Participants   [ Time Frame: Baseline ]

3.  Secondary:   Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV   [ Time Frame: 12 months ]

4.  Secondary:   Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV   [ Time Frame: 12 months ]

5.  Secondary:   Risk Factors for Hospitalization   [ Time Frame: Baseline and 12 months ]

6.  Secondary:   Compliance to Prescribed Palivizumab   [ Time Frame: 12 months ]

7.  Secondary:   Mean Number of Doses of Palivizumab Administered   [ Time Frame: 12 months ]


  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
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  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: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01297504     History of Changes
Other Study ID Numbers: P10-129
Study First Received: February 15, 2011
Results First Received: August 22, 2014
Last Updated: September 19, 2014
Health Authority: Uruguay: Comite de Etica
Colombia: Institutional Review Board
Peru: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Ecuador: Public Health Ministry
Argentina: Human Research Bioethics Committee
Chile: Institutional Review Board