Prospective, Study for the Use of Palivizumab (Synagis) in High Risk Children in Germany
This study is currently recruiting participants.
Verified February 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01155193
First received: March 2, 2010
Last updated: March 6, 2013
Last verified: February 2013
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Purpose
Evaluation of Respiratory Syncytial Virus (RSV) Hospitalization and the impact of risk factors on preterm infants, infants with congenital heart disease and infants with bronchopulmonary abnormality of development immunized with Synagis.
| Condition | Intervention |
|---|---|
|
Respiratory Syncytial Virus Infections |
Drug: palivizumab (Synagis) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Documentation of Safety and Efficacy of Synagis in Preterm Infants |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Determination of Synagis usage patterns in infants under risk of RSV (when [which month] and where [hospital or community based pediatrician] drug is administered [ Time Frame: Once per month during Respiratory Syncytial Virus-season ] [ Designated as safety issue: No ]
- Determination of RSV hospitalization rates among Synagis infants (for any reason and RSV-related) [ Time Frame: Once per month during Respiratory Syncytial Virus-season ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determination and evaluation of risk factors of the individual patient for complicated RSV disease [ Time Frame: Once per month during Respiratory Syncytial Virus-season ] [ Designated as safety issue: No ]
- Determination of parental compliance with the palivizumab administration schedule [ Time Frame: Once per month during Respiratory Syncytial Virus-season ] [ Designated as safety issue: No ]
- Determination of the Synagis usage in the german health care system [ Time Frame: Once per month during Respiratory Syncytial Virus-season ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20000 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Children with risk for Respiratory Syncytial Virus Infection
The study population will consist of preterm infants and children born with hemodynamically significant congenital heart disease
|
Drug: palivizumab (Synagis)
15 mg palivizumab / kg body weight once a month during the period of an increased risk for respiratory syncytial virus infections.
|
Detailed Description:
The Synagis Post-Marketing Observational Study (PMOS) will provide information:
- when and where the drug is administered
- how the risk factors are distributed in the investigated population
- how often RSV-related hospitalization and ICU admission occur
- on the compliance rate among parents of Synagis® infants
Eligibility| Ages Eligible for Study: | up to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Each community Pediatrician in care of preterm infants and/or children with congenital heart disease can participate in this study.
Criteria
Inclusion Criteria:
- Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the Respiratory syncytial virus season
- Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
- Children less than 2 years of age and with hemodynamically significant congenital heart disease.
Exclusion Criteria:
- Children with known hypersensitivity to Palivizumab or any component of the formulation, or other humanized monoclonal antibodies
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155193
Show 1063 Study Locations
Contacts
| Contact: Susanne Germann | #49 6122581168 | gehrmann.susanne@abbvie.com |
| Contact: Elisabeth Glaser-Caldow | #49 6122 581235 | elisabeth.glaser@abbvie.com |
Show 1063 Study LocationsSponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Stefan Simianer, MD | AbbVie Deutschland GmbH & Co. KG, Medical Department |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01155193 History of Changes |
| Other Study ID Numbers: | P10-410 |
| Study First Received: | March 2, 2010 |
| Last Updated: | March 6, 2013 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Keywords provided by AbbVie:
|
Respiratory syncytial virus Congenital heart disease Pre-term infants Children Infection |
Additional relevant MeSH terms:
|
Respiratory Syncytial Virus Infections Virus Diseases Pneumovirus Infections Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections |
Palivizumab Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013