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

Respiratory Syncytial Virus (RSV) Clinical Trial

— SUNRISE  

Official title:

Prospective, Multi-Center, Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Prescribed for Palivizumab Immunoprophylaxis in Routine Clinical Setting in the Russian Federation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282982
• Other study ID #: P14-579
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: June 4, 2015
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This is a non-interventional, prospective, multi-center study with no control group designed to access 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)). The patient population received immunoprophylaxis during the RSV season, defined as October 2014 through April 2015, in routine clinical settings throughout the Russian Federation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

• Planned prescription of palivizumab for immunoprophylaxis during RSV season or patients to whom palivizumab was prescribed and who received the first dose of palivizumab no later than 60 day before enrolment 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Syncytial Virus (RSV)

Intervention

Drug:
• Palivizumab
Palivizumab is a humanized IgG1 monoclonal antibody specific for the F-glycoprotein on the RSV surface.

Locations

Country	Name	City	State
Russian Federation	Site Reference ID/Investigator# 132560	Cheboksary
Russian Federation	Site Reference ID/Investigator# 132564	Chelyabinsk
Russian Federation	Site Reference ID/Investigator# 132565	Irkutsk
Russian Federation	Site Reference ID/Investigator# 132569	Kaliningrad
Russian Federation	Site Reference ID/Investigator# 132570	Kazan
Russian Federation	Site Reference ID/Investigator# 132554	Moscow
Russian Federation	Site Reference ID/Investigator# 132555	Moscow
Russian Federation	Site Reference ID/Investigator# 132556	Moscow
Russian Federation	Site Reference ID/Investigator# 132557	Moscow
Russian Federation	Site Reference ID/Investigator# 132558	Moscow
Russian Federation	Site Reference ID/Investigator# 134428	Moscow
Russian Federation	Site Reference ID/Investigator# 132559	Mytischi
Russian Federation	Site Reference ID/Investigator# 132566	Omsk
Russian Federation	Site Reference ID/Investigator# 132571	Orenburg
Russian Federation	Site Reference ID/Investigator# 132568	Ufa

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of infants hospitalized for lower Respiratory Tract Infection (LRTI)		Approximately 7 months	No
Secondary	Median length of Stay (LOS) of LRTI hospitalization		Approximately 7 months	No
Secondary	Proportion of patients with Intensive Care Unit (ICU) admission among hospitalized patients		Approximately 7 months	No
Secondary	Median length of Stay (LOS) of patients in the Intensive Care Unit (ICU)		Approximately 7 months	No
Secondary	Proportion of patients who received supplemental oxygen while hospitalized		Approximately 7 months	No
Secondary	Proportion of patients who received mechanical ventilation		Approximately 7 months	No
Secondary	Proportion of patients who missed 1 dose, 2 doses, = 3 doses		Approximately 7 months	No
Secondary	Proportion of patients with all co-morbidities within hospitalizations	Co-morbidities defined by International Statistical Classification of Diseases 10 revision (ICD-10)	Approximately 7 months	No
Secondary	Median duration of mechanical ventilation administration		Approximately 7 months	No
Secondary	Median duration of oxygen administration while hospitalized		Approximately 7 months	No
Secondary	Proportion of patients with a particular co-morbidity	Co-morbidities defined by International Statistical Classification of Diseases 10 revision (ICD-10)	Approximately 7 months	No

External Links

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