Respiratory Syncytial Virus (RSV)SUNRISENCT02282982
Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis
An observational study of Respiratory Syncytial Virus (RSV), run by AbbVie.
Trial summary
This was a non-interventional, prospective, multi-center study with no control group designed to assess the effectiveness of palivizumab in a population of infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary… Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- How many people
- 359 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to May 2015
- 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 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)) who received immunoprophylaxis during the RSV season defined as October 2014 through April 2015 in routine clinical settings in the Russian Federation.
Who may be able to join
- Planned prescription of palivizumab for immunoprophylaxis during RSV season or participants for whom palivizumab was prescribed and who received the first dose of palivizumab no later than 60 days before enrollment in the study
- Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:
- Infants born ≤35 weeks gestational age AND are ≤6 months of age at the onset of the RSV season;
- Infants ≤24 months of age AND with a diagnosis of BPD (defined as oxygen requirement at a corrected gestational age of 36 weeks);
- Infants ≤24 months of age with hemodynamically significant CHD, unoperated or partially corrected.
- Written authorization to use individual data signed by parents or child representative
Who cannot join
- Major congenital malformation aside from CHD
- Chronic pulmonary disease other than BPD
- Acute period of any infection
- Contraindication to palivizumab prescription according to local label
- Administration of a product possibly containing RSV-neutralizing antibody within 30 days prior to enrollment or current administration (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin)
About this study
Official title: Prospective, Multi-Center, Observational Program to Assess RSV Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis in Routine Clinical Setting in the Russian Federation
This was a non-interventional, prospective, multi-center study with no control group designed to assess the effectiveness of palivizumab in a population of infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)). Participants received immunoprophylaxis during the RSV season, defined as October 2014 through April 2015, in routine clinical settings throughout the Russian Federation.
Read the detailed description
Participants received intramuscular injections of palivizumab according to physicians' prescription and the local label. The local label recommended 1 month injection intervals between 5 sequential injections at a dose of 15 mg/kg. Participants could have received from 3 to 5 monthly injections of palivizumab during the 2014 - 2015 RSV season and the duration of this study.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- Immunoprophylaxis, Palivizumab
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 |
|---|---|---|
| Infants at high-risk of serious RSV illness | Infants who received immunoprophylaxis during the RSV season |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test
Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits.
Measured: Approximately 7 months
Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection
Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests.
Measured: Approximately 7 months
Secondary outcomes (10)
Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test
The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented.
Measured: Approximately 7 months
Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants
The number of hospitalized participants admitted to the Intensive Care Unit was documented.
Measured: Approximately 7 months
Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)
The median length of stay of hospitalized participants in the Intensive Care Unit was calculated.
Measured: Approximately 7 months
Proportion of Participants Who Received Supplemental Oxygen While Hospitalized
The proportion of participants who received supplemental oxygen while hospitalized was documented.
Measured: Approximately 7 months
Proportion of Participants Who Received Mechanical Ventilation While Hospitalized
The proportion of participants who received mechanical ventilation while hospitalized was documented.
Measured: Approximately 7 months
Proportion of Participants With Missed Doses of Palivizumab
The proportion of participants with missed or delayed doses of palivizumab was documented.
Measured: Approximately 7 months
Proportion of Participants With Co-morbidities During Hospitalizations
The proportion of participants with co-morbidities during hospitalizations was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).
Measured: Approximately 7 months
Median Duration of Mechanical Ventilation Administration During Hospitalizations
The median duration of mechanical ventilation administration during hospitalizations was calculated.
Measured: Approximately 7 months
Median Duration of Oxygen Administration During Hospitalizations
The median duration of mechanical oxygen administration during hospitalizations was calculated.
Measured: Approximately 7 months
Proportion of Participants With a Particular Co-morbidity
The proportion of participants with co-morbidities was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).
Measured: Approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionMay 2015
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 (RSV)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrey Strugovschikov, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282982
- Sponsor's protocol ID
- P14-579
- Acronym
- SUNRISE
- Status last verified
- Jun 2016
- First submitted
- 3 Nov 2014
- Last updated
- 29 Jul 2016
- 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 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center, Observational Program to Assess RSV Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis in Routine Clinical Setting in the Russian Federation
- ClinicalTrials.gov ID
- NCT02282982
- Acronym / sponsor ID
- SUNRISE / P14-579
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- Immunoprophylaxis, Palivizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Posted 28 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a non-interventional, prospective, multi-center study with no control group designed to assess the effectiveness of palivizumab in a population of infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)). Participants received immunoprophylaxis during the RSV season, defined as October 2014 through April 2015, in routine clinical settings throughout the Russian Federation.
Detailed description
Participants received intramuscular injections of palivizumab according to physicians' prescription and the local label. The local label recommended 1 month injection intervals between 5 sequential injections at a dose of 15 mg/kg. Participants could have received from 3 to 5 monthly injections of palivizumab during the 2014 - 2015 RSV season and the duration of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants at high-risk of serious RSV illness | – | –Infants who received immunoprophylaxis during the RSV season |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)) who received immunoprophylaxis during the RSV season defined as October 2014 through April 2015 in routine clinical settings in the Russian Federation.
Key inclusion criteria (6 listed)
- Planned prescription of palivizumab for immunoprophylaxis during RSV season or participants for whom palivizumab was prescribed and who received the first dose of palivizumab no later than 60 days before enrollment in the study
- Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:
- Written authorization to use individual data signed by parents or child representative
Key exclusion criteria (5 listed)
- Major congenital malformation aside from CHD
- Chronic pulmonary disease other than BPD
- Acute period of any infection
- Contraindication to palivizumab prescription according to local label
- Administration of a product possibly containing RSV-neutralizing antibody within 30 days prior to enrollment or current administration (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin)
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
Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test
Time frame: Approximately 7 months
Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits.
Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection
Time frame: Approximately 7 months
Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests.
10 secondary outcomes
Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test
Time frame: Approximately 7 months
Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants
Time frame: Approximately 7 months
Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)
Time frame: Approximately 7 months
Proportion of Participants Who Received Supplemental Oxygen While Hospitalized
Time frame: Approximately 7 months
Proportion of Participants Who Received Mechanical Ventilation While Hospitalized
Time frame: Approximately 7 months
Proportion of Participants With Missed Doses of Palivizumab
Time frame: Approximately 7 months
Proportion of Participants With Co-morbidities During Hospitalizations
Time frame: Approximately 7 months
Median Duration of Mechanical Ventilation Administration During Hospitalizations
Time frame: Approximately 7 months
Median Duration of Oxygen Administration During Hospitalizations
Time frame: Approximately 7 months
Proportion of Participants With a Particular Co-morbidity
Time frame: Approximately 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- 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.
Andrey Strugovschikov, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus (RSV), run by AbbVie.
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 6 inclusion and 5 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 Jul 2016. 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 28 Jun 2016). 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?
Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test (time frame: Approximately 7 months). The study lists 2 primary outcomes in all. 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 Jul 2016.