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Prospective, Study for the Use of Palivizumab (Synagis) in High Risk Children in Germany

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01155193
First received: March 2, 2010
Last updated: August 18, 2014
Last verified: August 2014
  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
Respiratory Syncytial Virus Infections

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: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155193

Contacts
Contact: Susanne Gehrmann #49 6122581168 gehrmann.susanne@abbvie.com
Contact: Elisabeth Glaser-Caldow #49 6122 581235 elisabeth.glaser@abbvie.com

  Show 1551 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Bianca Wittig, 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: August 18, 2014
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:
Infection
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on September 18, 2014