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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
History of Changes
  Purpose

Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that did not receive palivizumab


Condition
Severe Respiratory Syncytial Virus Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Palivizumab (Synagis®) Post-marketing Surveillance Cohort Study in Children < 24 Months of Age With Hemodynamically Significant Congenital Heart Disease

Resource links provided by NLM:

Drug Information available for: Palivizumab
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    The number of subjects who experienced at least 1 event of infection, arrhythmia, or death meeting any of the criteria for a serious adverse event

  • 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 ] [ Designated as safety issue: Yes ]
    The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event

  • 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 ] [ Designated as safety issue: Yes ]
    The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event

  • 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 ] [ Designated as safety issue: Yes ]
    The number of subjects who died


Enrollment: 2036
Study Start Date: July 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

This is an observational, non-interventional, retrospective cohort study of infants with hemodynamically significant congenital heart disease (HSCHD) who were less than 24 months of age when the first dose of palivizumab was administered (CASES), and infants who were diagnosed with hemodynamically significant congenital heart disease but did not receive palivizumab in a historical respiratory syncytial virus (RSV) season during the first 24 months of life (CONTROLS). CASES are matched to CONTROLS based on RSV season, age, type of cardiac lesion, and type of prior corrective cardiac surgery. Subject medical records are reviewed for occurrences of the clinical end points of infection, arrhythmia, and/or death that meet criteria for serious adverse events. The groups will be compared for number and percent of subjects who experience these primary serious adverse events (both individually and collectively) during a defined 8-month chart review period.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children less than 24 months of age with hemodynamically significant congenital heart disease

Criteria

Inclusion Criteria:

  1. Subject must have documented hemodynamically significant congenital heart disease (Note: Children with uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus are not eligible).
  2. Subject must have unoperated or partially corrected congenital heart disease.
  3. Subject must have received at least one dose of palivizumab for prophylaxis during the Respiratory Syncytial Virus season - September 1 through April 30 (CASES), or would have been considered eligible for palivizumab prophylaxis (CONTROLS).
  4. Subject must be < 24 months of age at the time of the first dose of palivizumab prophylaxis (CASES) or < 32 months of age at the end of the assigned Respiratory Syncytial Virus season in which they would have been eligible to receive palivizumab if the drug had been approved in the European Union (CONTROLS).
  5. Subject's parent, guardian, or legal representative has voluntarily signed and dated a Release of Information Form to allow the review of medical records and collection of pertinent study data.

Exclusion Criteria:

  1. Subject was contraindicated for treatment with palivizumab according to the current European product label.
  2. Subject had full correction of Congenital Heart Disease.
  3. Subject received palivizumab before approval for use in Congenital Heart Disease (CASES), or subject received palivizumab at any time (CONTROLS).
  4. Subject has already been included in this study in a prior Respiratory Syncytial Virus season.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075178

  Show 37 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Andrew Campbell, MD Medical Director, Abbott Laboratories
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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

Keywords provided by Abbott:
Infection
Arrhythmia
Death
Palivizumab
 Safety
Hemodynamically Significant Congenital Heart Disease
Pediatric
Observational

Additional relevant MeSH terms:
Heart Diseases
Respiratory Syncytial Virus Infections
Virus Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
 RNA Virus Infections
Cardiovascular Abnormalities
Congenital Abnormalities
Palivizumab
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013