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

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ClinicalTrials.gov Identifier: NCT01155193
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
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 or disease
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

Study Type : Observational
Actual Enrollment : 15446 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Documentation of Safety and Efficacy of Synagis in Preterm Infants
Study Start Date : November 2007
Primary Completion Date : July 2016
Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Palivizumab
U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  1. 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 ]
  2. Determination of RSV hospitalization rates among Synagis infants (for any reason and RSV-related) [ Time Frame: Once per month during Respiratory Syncytial Virus-season ]

Secondary Outcome Measures :
  1. Determination and evaluation of risk factors of the individual patient for complicated RSV disease [ Time Frame: Once per month during Respiratory Syncytial Virus-season ]
  2. Determination of parental compliance with the palivizumab administration schedule [ Time Frame: Once per month during Respiratory Syncytial Virus-season ]
  3. Determination of the Synagis usage in the german health care system [ Time Frame: Once per month during Respiratory Syncytial Virus-season ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155193


  Show 1218 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Sandra Bloch, MD AbbVie Deutschland GmbH & Co. KG, Medical Department

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01155193     History of Changes
Other Study ID Numbers: P10-410
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Children
Pre-term infants
Congenital heart disease
Infection
Respiratory syncytial virus

Additional relevant MeSH terms:
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Palivizumab
Antiviral Agents
Anti-Infective Agents