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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
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease. This registry was designed as a post-marketing observational study, and conducted with the aim of collecting data on palivizumab administration, the risk factors for complicated RSV disease, frequency of hospitalizations, and drug adherence.

Condition or disease
Respiratory Syncytial Virus Infections

Detailed Description:

Each participant included in this study was observed during his/her palivizumab prophylaxis during the prevailing RSV season. According to the requirements for non-interventional or observational studies, no diagnostic or monitoring procedures were applied to the participants included in the study other than those which would ordinarily be applied in the course of the individual therapeutic strategy. Only data which were part of routine medical care were collected.

Data collection was conducted initially in season 2002/2003 using paper-based case report forms (CRFs); beginning in season 2008/2009 a protected internet-based data entry platform was used. Both the paper-based CRFs and the electronic system were subject to changes during the whole time of the registry.

Data collection for registry seasons 2002/2003 - 2006/2007 was conducted by use of paper-based CRFs and hospitalization forms. Corresponding results were published in 2011 and are hence depicted together and reported here as a separate reporting group.

Registry seasons 2007/2008 and 2008/2009 were considered transitional years in the process of switching the type of data collection to an electronic CRF (eCRF) system. Although data collection of registry 2007/2008 was still paper-based, it was not included in the original publication and hence, results are reported separately. In season 2008/2009 the mode of data collection was switched from paper-based CRFs to an eCRF system, however, several physicians still used the paper-based CRFs for documentation. In order to use all documentations and lose as few data as possible, results for 2008/2009 are based on a combination of paper-based CRF and eCRF data. Hence, it was decided to keep the results for 08/09 separate from the depiction of the homogenous, eCRF-based results of the following seasons.

Data collection for registry 09/10 - 15/16 was implemented by an eCRF system. Corresponding results are therefore depicted together in one reporting group.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 30804 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Months
Official Title: Prospective, Non-interventional Observation Study for the Use of Palivizumab in High-risk Children in Germany- SYNAGIS
Actual Study Start Date : September 1, 2002
Actual Primary Completion Date : July 31, 2016
Actual Study Completion Date : July 31, 2016


Group/Cohort
Palivizumab
Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season.



Primary Outcome Measures :
  1. Percentage of Participants With RSV-associated Hospitalization [ Time Frame: During RSV season (September to June) from 2002 to 2016 ]

Secondary Outcome Measures :
  1. Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 [ Time Frame: During RSV season (September to June) from 2002 to 2008 ]
    Hospitalization due to RSV was documented on a separate hospitalization form. The data below represent the number of hospitalizations documented on forms; some participants may have had more than one hospitalization. Multiple entries for discharge diagnosis were possible.

  2. Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 [ Time Frame: During RSV season (September to June) from 2008 to 2016 ]
    In the season 2008/09, the eCRF system for data collection was introduced. Hospitalization due to RSV infection was documented on a separate hospitalization form in the electronic case report form (eCRF). Physicians were asked to specify a primary diagnosis at hospital discharge.

  3. Presence of Complications During Hospitalization [ Time Frame: During RSV season (September to June) from 2002 to 2016 ]
  4. Parental Cooperation in Registries 02/03 - 06/07 and 07/08 [ Time Frame: During RSV season (September to June) from 2002 to 2008 ]
    Cooperation of parents with the prophylaxis regimen was categorized as very good, good, moderate, bad or very bad.

  5. Parental Cooperation for Registry 08/09 and 09/10 - 15/16 [ Time Frame: During RSV season (September to June) from 2008 to 2016 ]

    Cooperation of parents with the prophylaxis regimen was evaluated per injection in registry 08/09 and 09/10 - 15/16. The categories for cooperation ratings were changed to good, satisfying, or bad:

    Good: all palivizumab doses could be administered as planned; Satisfying: a single palivizumab dose was missed by the parents; Bad: more than one palivizumab doses was missed by the parents.


  6. Mean Number of Palivizumab Injections [ Time Frame: During RSV season (September to June) from 2002 to 2016 ]
    The mean number of palivizumab injections per participant, per season.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care pediatricians from hospital outpatient facilities and neonatologists from inpatient facilities were invited to participate in this study and enrolled subjects into the registry at their discretion.
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


Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
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Study Director: Sandra Bloch, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
Additional Information:
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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01155193    
Other Study ID Numbers: P10-410
First Posted: July 1, 2010    Key Record Dates
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018
Last Verified: July 2017
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Children
Pre-term infants
Congenital heart disease
Infection
Respiratory syncytial virus
Bronchopulmonary dysplasia (BPD)
Chronic lung disease (CLD)
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections