Severe Respiratory Syncytial Virus InfectionNCT01075178

Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

An observational study of Severe Respiratory Syncytial Virus Infection, run by Abbott at 37 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages Up to 24 months
Conditions the study is for: Severe Respiratory Syncytial Virus Infection
How many people: 2,036 participants
Where: 37 sitesin 10 countries
Study dates: Jul 2006to Jan 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 24 months
All sexes
No healthy volunteers
Child

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

Who may be able to join

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).
Subject must have unoperated or partially corrected congenital heart disease.
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).
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).
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.

Who cannot join

Subject was contraindicated for treatment with palivizumab according to the current European product label.
Subject had full correction of Congenital Heart Disease.
Subject received palivizumab before approval for use in Congenital Heart Disease (CASES), or subject received palivizumab at any time (CONTROLS).
Subject has already been included in this study in a prior Respiratory Syncytial Virus season.

Trial locations and contacts

37 sites in 10 countries.

Country

City, postcode or hospital

37 sites in 10 countries

Germany9 sites

Site Reference ID/Investigator# 6280
Bad Oeynhausen, 32545
Site Reference ID/Investigator# 9621
Berlin, 10779
Site Reference ID/Investigator# 16361
Braunschweig, 38102
Site Reference ID/Investigator# 6283
Duisburg, 47137
Site Reference ID/Investigator# 6272
Essen, 45147
Site Reference ID/Investigator# 6271
Göttingen, 37075
Site Reference ID/Investigator# 8277
Munich, 81377
Site Reference ID/Investigator# 11182
Rostock, 18057
Site Reference ID/Investigator# 6249
Sankt Augustin, 53757

Other trials in Germany

Italy5 sites

Site Reference ID/Investigator# 6274
Campobasso, 86100
Site Reference ID/Investigator# 6276
Florence, 50139
Site Reference ID/Investigator# 4703
Naples, 80100
Site Reference ID/Investigator# 4910
Padova, 35128
Site Reference ID/Investigator# 14681
Roma, 00165

Other trials in Italy

France4 sites

Site Reference ID/Investigator# 6244
Nantes, 44093
Site Reference ID/Investigator# 6261
Paris, 75019
Site Reference ID/Investigator# 6245
Paris, CEDEX 15
Site Reference ID/Investigator#6260
Reims, 51092

Other trials in France

Poland4 sites

Site Reference ID/Investigator# 6275
Bydgoszcz, 85-168
Site Reference ID/Investigator# 13102
Katowice, 40-752
Site Reference ID/Investigator# 6270
Krakow, 3-663
Site Reference ID/Investigator# 12222
Warsaw, 04-730

Other trials in Poland

Spain4 sites

Site Reference ID/Investigator# 5372
A Coruña, 15006
Site Reference ID/Investigator# 15381
Madrid, 28009
Site Reference ID/Investigator# 15702
Madrid, 28034
Site Reference ID/Investigator# 15261
Santiago de Compostela, 15706

Other trials in Spain

Austria3 sites

Site Reference ID/Investigator# 6263
Linz, 4020
Site Reference ID/Investigator# 7956
Vienna, 1090
Site Reference ID/Investigator# 9403
Vienna, 1100

Other trials in Austria

Belgium3 sites

Site Reference ID/Investigator# 17821
Brussels, 1200
Site Reference ID/Investigator# 18602
Ghent, 9000
Site Reference ID/Investigator# 18601
Leuven, 3000

Other trials in Belgium

United Kingdom3 sites

Site Reference ID/Investigator# 6282
Belfast, BT12 6BE
Site Reference ID/Investigator# 13941
Bristol, BS2 8BJ
Site Reference ID/Investigator# 5023
London, SW3 6NP

Other trials in United Kingdom

Norway1 site

Site Reference ID/Investigator# 14802
Trondheim, 7006

Other trials in Norway

Slovenia1 site

Site Reference ID/Investigator# 14682
Ljubljana, 1525

Other trials in Slovenia

About this study

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

Read the 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.

Conditions: Severe Respiratory Syncytial Virus Infection
Keywords: Infection, Arrhythmia, Death, Palivizumab, Safety, Hemodynamically Significant Congenital Heart Disease, Pediatric, Observational
Medical subject headings: Respiratory Syncytial Virus Infections, Infections, Arrhythmias, Cardiac, Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01075178
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death
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
Measured: 8-month chart review period in CASES and CONTROLS
Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection.
The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event
Measured: 8-month chart review period in CASES and CONTROLS
Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia
The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event
Measured: 8-month chart review period in CASES and CONTROLS
Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death
The number of subjects who died
Measured: 8-month chart review period in CASES and CONTROLS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2006Jan 2010

First posted25 Feb 2010 (estimated)
Study startJul 2006
Primary completionJan 2010
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Severe Respiratory Syncytial Virus InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 2,036 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01075178
Sponsor's protocol ID: M03-681
Status last verified: Mar 2011
First submitted: 23 Feb 2010
Last updated: 23 Mar 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease
RSV
Not yet recruitingObservational study
Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
RecruitingPhase 2
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
Respiratory Syncytial Virus Infections
Active, not recruitingObservational study
RSV, Influenza, and SARS-CoV-2 Outcomes in Severely Immunosuppressed Adults
Respiratory Syncytial Virus Infections, Immunocompromised Host
Not yet recruitingObservational study
ELderly REspiratory VIral Cohort
Influenza Viruses, Respiratory Syncytial Virus (RSV)

All Severe Respiratory Syncytial Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Palivizumab (Synagis®) Post-marketing Surveillance Cohort Study in Children < 24 Months of Age With Hemodynamically Significant Congenital Heart Disease
ClinicalTrials.gov ID: NCT01075178
Acronym / sponsor ID: M03-681
Conditions: Severe Respiratory Syncytial Virus Infection
Keywords: Infection, Arrhythmia, Death, Palivizumab, Safety, Hemodynamically Significant Congenital Heart Disease, Pediatric, Observational
Study type: Observational
Recruitment status: Completed
Enrolment: 2,036 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Jul 2006
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 25 Feb 2010 (estimated)
Results: Posted 24 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: Up to 24 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Children less than 24 months of age with hemodynamically significant congenital heart disease

Key inclusion criteria (5 listed)

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).
Subject must have unoperated or partially corrected congenital heart disease.
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).
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).
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.

Key exclusion criteria (4 listed)

Subject was contraindicated for treatment with palivizumab according to the current European product label.
Subject had full correction of Congenital Heart Disease.
Subject received palivizumab before approval for use in Congenital Heart Disease (CASES), or subject received palivizumab at any time (CONTROLS).
Subject has already been included in this study in a prior Respiratory Syncytial Virus season.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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
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
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
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

Results and safety

Results posted to the registry on 24 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Palivizumab-treated Subjects (CASES)	1,148	1,018
Non-palivizumab-treated Subjects (CONTROLS)	1,421	1,018

Primary outcome: 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. Number. Unit: participants

Measure	Palivizumab-treated Subjects (CASES) n = 1009	Non-palivizumab-treated Subjects (CONTROLS) n = 1009
Value	303	349

Palivizumab-treated Subjects (CASES) vs Non-palivizumab-treated Subjects (CONTROLS): Observed odds ratio: 0.81, exact binomial

Population analysed: The population analyzed included the full analysis set.

Primary outcome: 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. Number. Unit: participants

Measure	Palivizumab-treated Subjects (CASES) n = 1009	Non-palivizumab-treated Subjects (CONTROLS) n = 1009
Value	281	329

Palivizumab-treated Subjects (CASES) vs Non-palivizumab-treated Subjects (CONTROLS): Observed odds ratio: 0.80, exact binomial

Population analysed: The population analyzed included the full analysis set.

Primary outcome: 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. Number. Unit: participants

Measure	Palivizumab-treated Subjects (CASES) n = 1009	Non-palivizumab-treated Subjects (CONTROLS) n = 1009
Value	41	39

Palivizumab-treated Subjects (CASES) vs Non-palivizumab-treated Subjects (CONTROLS): Observed odds ratio: 1.05, exact binomial

Population analysed: The population analyzed included the full analysis set.

Primary outcome: 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. Number. Unit: participants

Measure	Palivizumab-treated Subjects (CASES) n = 1009	Non-palivizumab-treated Subjects (CONTROLS) n = 1009
Value	9	10

Palivizumab-treated Subjects (CASES) vs Non-palivizumab-treated Subjects (CONTROLS): Observed odds ratio: 0.90, exact binomial

Population analysed: The population analyzed included the full analysis set.

Adverse events

Time frame: 8-month chart review period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Palivizumab-treated Subjects (CASES)	303 of 1,009 (30%)	0 of 0	Not reported
Non-palivizumab-treated Subjects (CONTROLS)	349 of 1,009 (34.6%)	0 of 0	Not reported

Limitations and caveats (from the sponsor): Only serious adverse events of infection and arrhythmia as well as deaths were collected in this study. The criterion for non-inferiority was not met for death, most likely because the reported mortality rates were lower than expected in both groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Severe Respiratory Syncytial Virus Infection

RecruitingPhase 2/3
A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease
RSV
Not yet recruitingObservational study
Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
RecruitingPhase 2
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
Respiratory Syncytial Virus Infections
Active, not recruitingObservational study
RSV, Influenza, and SARS-CoV-2 Outcomes in Severely Immunosuppressed Adults
Respiratory Syncytial Virus Infections, Immunocompromised Host
Not yet recruitingObservational study
ELderly REspiratory VIral Cohort
Influenza Viruses, Respiratory Syncytial Virus (RSV)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Campbell, MD study director

Medical Director, Abbott Laboratories

37 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Respiratory Syncytial Virus Infection, run by Abbott at 37 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Germany, Italy, France, Poland, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01075178.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2011.