Clinical trial NCT01075178: Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
Official title: Palivizumab (Synagis®) Post-marketing Surveillance Cohort Study in Children < 24 Months of Age With Hemodynamically Significant Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Respiratory Syncytial Virus Infection
Keywords: Infection
Arrhythmia
Death
Palivizumab
Safety
Hemodynamically Significant Congenital Heart Disease
Pediatric
Observational
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 2036
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children less than 24 months of age with hemodynamically significant congenital heart disease

Brief summary: 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

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 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.

Primary outcomes:
measure: Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death
timeFrame: 8-month chart review period in CASES and CONTROLS
measure: Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection.
timeFrame: 8-month chart review period in CASES and CONTROLS
measure: Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia
timeFrame: 8-month chart review period in CASES and CONTROLS
measure: Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death
timeFrame: 8-month chart review period in CASES and CONTROLS
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 6263
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 7956
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 9403
city: Brussels
country: Belgium
facility: Site Reference ID/Investigator# 17821
city: Gent
country: Belgium
facility: Site Reference ID/Investigator# 18602
city: Leuven
country: Belgium
facility: Site Reference ID/Investigator# 18601
city: Nantes
country: France
facility: Site Reference ID/Investigator# 6244
city: Paris
country: France
facility: Site Reference ID/Investigator# 6261
city: Paris
country: France
facility: Site Reference ID/Investigator# 6245
city: Reims
country: France
facility: Site Reference ID/Investigator#6260
city: Bad Oeynhausen
country: Germany
facility: Site Reference ID/Investigator# 6280
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 9621
city: Braunschweig
country: Germany
facility: Site Reference ID/Investigator# 16361
city: Duisburg
country: Germany
facility: Site Reference ID/Investigator# 6283
city: Essen
country: Germany
facility: Site Reference ID/Investigator# 6272
city: Goettingen
country: Germany
facility: Site Reference ID/Investigator# 6271
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 8277
city: Rostock
country: Germany
facility: Site Reference ID/Investigator# 11182
city: St. Augustin
country: Germany
facility: Site Reference ID/Investigator# 6249
city: Campobasso
country: Italy
facility: Site Reference ID/Investigator# 6274
city: Florence
country: Italy
facility: Site Reference ID/Investigator# 6276
city: Naples
country: Italy
facility: Site Reference ID/Investigator# 4703
city: Padova
country: Italy
facility: Site Reference ID/Investigator# 4910
city: Roma
country: Italy
facility: Site Reference ID/Investigator# 14681
city: Trondheim
country: Norway
facility: Site Reference ID/Investigator# 14802
city: Bydgoszcz
country: Poland
facility: Site Reference ID/Investigator# 6275
city: Katowice
country: Poland
facility: Site Reference ID/Investigator# 13102
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 6270
city: Warsaw
country: Poland
facility: Site Reference ID/Investigator# 12222
city: Ljubljana
country: Slovenia
facility: Site Reference ID/Investigator# 14682
city: A Coruna
country: Spain
facility: Site Reference ID/Investigator# 5372
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 15381
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 15702
city: Santiago de Compostela
country: Spain
facility: Site Reference ID/Investigator# 15261
city: Belfast
country: United Kingdom
facility: Site Reference ID/Investigator# 6282
city: Bristol
country: United Kingdom
facility: Site Reference ID/Investigator# 13941
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 5023
Study officials:
affiliation: Medical Director, Abbott Laboratories
name: Andrew Campbell, MD
role: STUDY_DIRECTOR
References: