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

NCT02282982 | Completed Results

• 1 other identifier: P14-579
• Study Type: observational
• Target: 359
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

Immunoprophylaxis; Palivizumab

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Approximately 7 months

• Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants

  Approximately 7 months

• Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)

  Approximately 7 months

• Proportion of Participants Who Received Supplemental Oxygen While Hospitalized

  Approximately 7 months

• Proportion of Participants Who Received Mechanical Ventilation While Hospitalized

  Approximately 7 months

Study Arms (1)

Infants at high-risk of serious RSV illness

Infants who received immunoprophylaxis during the RSV season

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Andrey Strugovschikov, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 29, 2016
• Results First Posted: June 28, 2016

Record last verified: 2016-06