Severe Respiratory Syncytial Virus Infection Clinical Trial
Official title:
Palivizumab (Synagis®) Post-marketing Surveillance Cohort Study in Children < 24 Months of Age With Hemodynamically Significant Congenital Heart Disease
| Verified date | March 2011 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | European Union: European Medicines Agency |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 2036 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 24 Months |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | Site Reference ID/Investigator# 6263 | Linz | |
| Austria | Site Reference ID/Investigator# 7956 | Vienna | |
| Austria | Site Reference ID/Investigator# 9403 | Vienna | |
| Belgium | Site Reference ID/Investigator# 17821 | Brussels | |
| Belgium | Site Reference ID/Investigator# 18602 | Gent | |
| Belgium | Site Reference ID/Investigator# 18601 | Leuven | |
| France | Site Reference ID/Investigator# 6244 | Nantes | |
| France | Site Reference ID/Investigator# 6245 | Paris | |
| France | Site Reference ID/Investigator# 6261 | Paris | |
| France | Site Reference ID/Investigator#6260 | Reims | |
| Germany | Site Reference ID/Investigator# 6280 | Bad Oeynhausen | |
| Germany | Site Reference ID/Investigator# 9621 | Berlin | |
| Germany | Site Reference ID/Investigator# 16361 | Braunschweig | |
| Germany | Site Reference ID/Investigator# 6283 | Duisburg | |
| Germany | Site Reference ID/Investigator# 6272 | Essen | |
| Germany | Site Reference ID/Investigator# 6271 | Goettingen | |
| Germany | Site Reference ID/Investigator# 8277 | Munich | |
| Germany | Site Reference ID/Investigator# 11182 | Rostock | |
| Germany | Site Reference ID/Investigator# 6249 | St. Augustin | |
| Italy | Site Reference ID/Investigator# 6274 | Campobasso | |
| Italy | Site Reference ID/Investigator# 6276 | Florence | |
| Italy | Site Reference ID/Investigator# 4703 | Naples | |
| Italy | Site Reference ID/Investigator# 4910 | Padova | |
| Italy | Site Reference ID/Investigator# 14681 | Roma | |
| Norway | Site Reference ID/Investigator# 14802 | Trondheim | |
| Poland | Site Reference ID/Investigator# 6275 | Bydgoszcz | |
| Poland | Site Reference ID/Investigator# 13102 | Katowice | |
| Poland | Site Reference ID/Investigator# 6270 | Krakow | |
| Poland | Site Reference ID/Investigator# 12222 | Warsaw | |
| Slovenia | Site Reference ID/Investigator# 14682 | Ljubljana | |
| Spain | Site Reference ID/Investigator# 5372 | A Coruna | |
| Spain | Site Reference ID/Investigator# 15381 | Madrid | |
| Spain | Site Reference ID/Investigator# 15702 | Madrid | |
| Spain | Site Reference ID/Investigator# 15261 | Santiago de Compostela | |
| United Kingdom | Site Reference ID/Investigator# 6282 | Belfast | |
| United Kingdom | Site Reference ID/Investigator# 13941 | Bristol | |
| United Kingdom | Site Reference ID/Investigator# 5023 | London |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
Austria, Belgium, France, Germany, Italy, Norway, Poland, Slovenia, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 8-month chart review period in CASES and CONTROLS | Yes |
| Primary | 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 | 8-month chart review period in CASES and CONTROLS | Yes |
| Primary | 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 | 8-month chart review period in CASES and CONTROLS | Yes |
| Primary | Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death | The number of subjects who died | 8-month chart review period in CASES and CONTROLS | Yes |