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Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

NCT ID: NCT01075178

Last Updated: 2011-03-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2036 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-01-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Severe Respiratory Syncytial Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Palivizumab-treated subjects (CASES)

HSCHD infants, \<2 yrs old at first dose of palivizumab

No interventions assigned to this group

Non-palivizumab-treated subjects (CONTROLS)

HSCHD infants, \<2 yrs old that did not receive palivizumab

No interventions assigned to this group

Eligibility Criteria

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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.
Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Andrew Campbell, MD

Role: STUDY_DIRECTOR

Medical Director, Abbott Laboratories

Locations

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Site Reference ID/Investigator# 6263

Linz, , Austria

Site Status

Site Reference ID/Investigator# 7956

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 9403

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 17821

Brussels, , Belgium

Site Status

Site Reference ID/Investigator# 18602

Ghent, , Belgium

Site Status

Site Reference ID/Investigator# 18601

Leuven, , Belgium

Site Status

Site Reference ID/Investigator# 6244

Nantes, , France

Site Status

Site Reference ID/Investigator# 6261

Paris, , France

Site Status

Site Reference ID/Investigator# 6245

Paris, , France

Site Status

Site Reference ID/Investigator#6260

Reims, , France

Site Status

Site Reference ID/Investigator# 6280

Bad Oeynhausen, , Germany

Site Status

Site Reference ID/Investigator# 9621

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 16361

Braunschweig, , Germany

Site Status

Site Reference ID/Investigator# 6283

Duisburg, , Germany

Site Status

Site Reference ID/Investigator# 6272

Essen, , Germany

Site Status

Site Reference ID/Investigator# 6271

Göttingen, , Germany

Site Status

Site Reference ID/Investigator# 8277

Munich, , Germany

Site Status

Site Reference ID/Investigator# 11182

Rostock, , Germany

Site Status

Site Reference ID/Investigator# 6249

Sankt Augustin, , Germany

Site Status

Site Reference ID/Investigator# 6274

Campobasso, , Italy

Site Status

Site Reference ID/Investigator# 6276

Florence, , Italy

Site Status

Site Reference ID/Investigator# 4703

Naples, , Italy

Site Status

Site Reference ID/Investigator# 4910

Padua, , Italy

Site Status

Site Reference ID/Investigator# 14681

Roma, , Italy

Site Status

Site Reference ID/Investigator# 14802

Trondheim, , Norway

Site Status

Site Reference ID/Investigator# 6275

Bydgoszcz, , Poland

Site Status

Site Reference ID/Investigator# 13102

Katowice, , Poland

Site Status

Site Reference ID/Investigator# 6270

Krakow, , Poland

Site Status

Site Reference ID/Investigator# 12222

Warsaw, , Poland

Site Status

Site Reference ID/Investigator# 14682

Ljubljana, , Slovenia

Site Status

Site Reference ID/Investigator# 5372

A Coruña, , Spain

Site Status

Site Reference ID/Investigator# 15381

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 15702

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 15261

Santiago de Compostela, , Spain

Site Status

Site Reference ID/Investigator# 6282

Belfast, , United Kingdom

Site Status

Site Reference ID/Investigator# 13941

Bristol, , United Kingdom

Site Status

Site Reference ID/Investigator# 5023

London, , United Kingdom

Site Status

Countries

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Austria Belgium France Germany Italy Norway Poland Slovenia Spain United Kingdom

Related Links

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http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=23151&CFID

Related Info

Other Identifiers

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M03-681

Identifier Type: -

Identifier Source: org_study_id

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