Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

March 18, 2011 updated by: Abbott

Palivizumab (Synagis®) Post-marketing Surveillance Cohort Study in Children < 24 Months of Age With Hemodynamically Significant Congenital Heart Disease

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2036

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
8-month chart review period in CASES and CONTROLS
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
The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event
8-month chart review period in CASES and CONTROLS
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
The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event
8-month chart review period in CASES and CONTROLS
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
The number of subjects who died
8-month chart review period in CASES and CONTROLS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Andrew Campbell, MD, Medical Director, Abbott Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2006

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M03-681

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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