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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075178

  Hide Study Locations
Locations
Austria
Site Reference ID/Investigator# 6263
Linz, Austria, 4020
Site Reference ID/Investigator# 7956
Vienna, Austria, 1090
Site Reference ID/Investigator# 9403
Vienna, Austria, 1100
Belgium
Site Reference ID/Investigator# 17821
Brussels, Belgium, 1200
Site Reference ID/Investigator# 18602
Gent, Belgium, 9000
Site Reference ID/Investigator# 18601
Leuven, Belgium, 3000
France
Site Reference ID/Investigator# 6244
Nantes, France, 44093
Site Reference ID/Investigator# 6261
Paris, France, 75019
Site Reference ID/Investigator# 6245
Paris, France, CEDEX 15
Site Reference ID/Investigator#6260
Reims, France, 51092
Germany
Site Reference ID/Investigator# 6280
Bad Oeynhausen, Germany, 32545
Site Reference ID/Investigator# 9621
Berlin, Germany, 10779
Site Reference ID/Investigator# 16361
Braunschweig, Germany, 38102
Site Reference ID/Investigator# 6283
Duisburg, Germany, 47137
Site Reference ID/Investigator# 6272
Essen, Germany, 45147
Site Reference ID/Investigator# 6271
Goettingen, Germany, 37075
Site Reference ID/Investigator# 8277
Munich, Germany, 81377
Site Reference ID/Investigator# 11182
Rostock, Germany, 18057
Site Reference ID/Investigator# 6249
St. Augustin, Germany, 53757
Italy
Site Reference ID/Investigator# 6274
Campobasso, Italy, 86100
Site Reference ID/Investigator# 6276
Florence, Italy, 50139
Site Reference ID/Investigator# 4703
Naples, Italy, 80100
Site Reference ID/Investigator# 4910
Padova, Italy, 35128
Site Reference ID/Investigator# 14681
Roma, Italy, 00165
Norway
Site Reference ID/Investigator# 14802
Trondheim, Norway, 7006
Poland
Site Reference ID/Investigator# 6275
Bydgoszcz, Poland, 85-168
Site Reference ID/Investigator# 13102
Katowice, Poland, 40-752
Site Reference ID/Investigator# 6270
Krakow, Poland, 3-663
Site Reference ID/Investigator# 12222
Warsaw, Poland, 04-730
Slovenia
Site Reference ID/Investigator# 14682
Ljubljana, Slovenia, 1525
Spain
Site Reference ID/Investigator# 5372
A Coruna, Spain, 15006
Site Reference ID/Investigator# 15381
Madrid, Spain, 28009
Site Reference ID/Investigator# 15702
Madrid, Spain, 28034
Site Reference ID/Investigator# 15261
Santiago de Compostela, Spain, 15706
United Kingdom
Site Reference ID/Investigator# 6282
Belfast, United Kingdom, BT12 6BE
Site Reference ID/Investigator# 13941
Bristol, United Kingdom, BS2 8BJ
Site Reference ID/Investigator# 5023
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Abbott
Investigators
Study Director: Andrew Campbell, MD Medical Director, Abbott Laboratories
  More Information

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

ClinicalTrials.gov processed this record on October 20, 2014