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

Completed

• Conditions: Respiratory Syncytial Virus (RSV)

• Registration Number: NCT02282982
• Lead Sponsor: AbbVie

Brief 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 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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-05-20
• Results First Submitted QC: 2016-05-20
• Status Verified: 2016-06
• Results First Posted: 2016-06-28
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 359

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test	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	Approximately 7 months	Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests.

Secondary Outcome Measures

Name	Time	Method
Median Duration of Mechanical Ventilation Administration During Hospitalizations	Approximately 7 months	The median duration of mechanical ventilation administration during hospitalizations was calculated.
Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test	Approximately 7 months	The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented.
Proportion of Participants With a Particular Co-morbidity	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).
Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants	Approximately 7 months	The number of hospitalized participants admitted to the Intensive Care Unit was documented.
Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)	Approximately 7 months	The median length of stay of hospitalized participants in the Intensive Care Unit was calculated.
Proportion of Participants With Missed Doses of Palivizumab	Approximately 7 months	The proportion of participants with missed or delayed doses of palivizumab was documented.
Proportion of Participants With Co-morbidities During Hospitalizations	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).
Proportion of Participants Who Received Supplemental Oxygen While Hospitalized	Approximately 7 months	The proportion of participants who received supplemental oxygen while hospitalized was documented.
Proportion of Participants Who Received Mechanical Ventilation While Hospitalized	Approximately 7 months	The proportion of participants who received mechanical ventilation while hospitalized was documented.
Median Duration of Oxygen Administration During Hospitalizations	Approximately 7 months	The median duration of mechanical oxygen administration during hospitalizations was calculated.