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 (SUNRISE)

June 29, 2016 updated by: AbbVie

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.

Study Overview

Status

Completed

Conditions

Respiratory Syncytial Virus (RSV)

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 Type

Observational

Enrollment (Actual)

359

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Infants at high-risk of serious RSV illness Infants who received immunoprophylaxis during the RSV season

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 7 months
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.	Approximately 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented.	Approximately 7 months
Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants Time Frame: Approximately 7 months	The number of hospitalized participants admitted to the Intensive Care Unit was documented.	Approximately 7 months
Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU) Time Frame: Approximately 7 months	The median length of stay of hospitalized participants in the Intensive Care Unit was calculated.	Approximately 7 months
Proportion of Participants Who Received Supplemental Oxygen While Hospitalized Time Frame: Approximately 7 months	The proportion of participants who received supplemental oxygen while hospitalized was documented.	Approximately 7 months
Proportion of Participants Who Received Mechanical Ventilation While Hospitalized Time Frame: Approximately 7 months	The proportion of participants who received mechanical ventilation while hospitalized was documented.	Approximately 7 months
Proportion of Participants With Missed Doses of Palivizumab Time Frame: Approximately 7 months	The proportion of participants with missed or delayed doses of palivizumab was documented.	Approximately 7 months
Proportion of Participants With Co-morbidities During Hospitalizations Time Frame: Approximately 7 months	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).	Approximately 7 months
Median Duration of Mechanical Ventilation Administration During Hospitalizations Time Frame: Approximately 7 months	The median duration of mechanical ventilation administration during hospitalizations was calculated.	Approximately 7 months
Median Duration of Oxygen Administration During Hospitalizations Time Frame: Approximately 7 months	The median duration of mechanical oxygen administration during hospitalizations was calculated.	Approximately 7 months
Proportion of Participants With a Particular Co-morbidity Time Frame: Approximately 7 months	The proportion of participants with co-morbidities was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).	Approximately 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

Study Director: Andrey Strugovschikov, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria