Respiratory Syncytial Virus InfectionsNCT01155193
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
An observational study of Respiratory Syncytial Virus Infections, run by AbbVie (prior sponsor, Abbott).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- How many people
- 30,804 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2002to 31 Jul 2016
- How long will I take part?
- 10 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Children with known hypersensitivity to palivizumab or any component of the formulation, or other humanized monoclonal antibodies
About this study
Official title: Prospective, Non-interventional Observation Study for the Use of Palivizumab in High-risk Children in Germany- SYNAGIS
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.
Read the 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.
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Children, Pre-term infants, Congenital heart disease, Infection, Respiratory syncytial virus, Bronchopulmonary dysplasia (BPD), Chronic lung disease (CLD)
- Medical subject headings
- Respiratory Syncytial Virus Infections, Heart Defects, Congenital, Infections, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With RSV-associated Hospitalization
Measured: During RSV season (September to June) from 2002 to 2016
Secondary outcomes (6)
Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08
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.
Measured: During RSV season (September to June) from 2002 to 2008
Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16
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.
Measured: During RSV season (September to June) from 2008 to 2016
Presence of Complications During Hospitalization
Measured: During RSV season (September to June) from 2002 to 2016
Parental Cooperation in Registries 02/03 - 06/07 and 07/08
Cooperation of parents with the prophylaxis regimen was categorized as very good, good, moderate, bad or very bad.
Measured: During RSV season (September to June) from 2002 to 2008
Parental Cooperation for Registry 08/09 and 09/10 - 15/16
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.
Measured: During RSV season (September to June) from 2008 to 2016
Mean Number of Palivizumab Injections
The mean number of palivizumab injections per participant, per season.
Measured: During RSV season (September to June) from 2002 to 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study start1 Sep 2002
- Primary completion31 Jul 2016
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,804 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra Bloch, MD, Study director, AbbVie Deutschland GmbH & Co. KG, Medical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155193
- Sponsor's protocol ID
- P10-410
- Status last verified
- Jul 2017
- First submitted
- 2 Mar 2010
- Last updated
- 29 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-interventional Observation Study for the Use of Palivizumab in High-risk Children in Germany- SYNAGIS
- ClinicalTrials.gov ID
- NCT01155193
- Acronym / sponsor ID
- P10-410
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Children, Pre-term infants, Congenital heart disease, Infection, Respiratory syncytial virus, Bronchopulmonary dysplasia (BPD), Chronic lung disease (CLD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,804 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2002 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 29 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Children with known hypersensitivity to palivizumab or any component of the formulation, or other humanized monoclonal antibodies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With RSV-associated Hospitalization
Time frame: During RSV season (September to June) from 2002 to 2016
6 secondary outcomes
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
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
Presence of Complications During Hospitalization
Time frame: During RSV season (September to June) from 2002 to 2016
Parental Cooperation in Registries 02/03 - 06/07 and 07/08
Time frame: During RSV season (September to June) from 2002 to 2008
Parental Cooperation for Registry 08/09 and 09/10 - 15/16
Time frame: During RSV season (September to June) from 2008 to 2016
Mean Number of Palivizumab Injections
Time frame: During RSV season (September to June) from 2002 to 2016
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Bloch, MD study director
AbbVie Deutschland GmbH & Co. KG, Medical Department
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infections, run by AbbVie (prior sponsor, Abbott).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With RSV-associated Hospitalization (time frame: During RSV season (September to June) from 2002 to 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.