Clinical trial NCT02282982: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus (RSV)
Keywords: Immunoprophylaxis
Palivizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-11-05
Enrollment: 359
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test
timeFrame: Approximately 7 months
measure: Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection
timeFrame: Approximately 7 months
Secondary outcomes:
measure: Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test
timeFrame: Approximately 7 months
measure: Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants
timeFrame: Approximately 7 months
measure: Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)
timeFrame: Approximately 7 months
measure: Proportion of Participants Who Received Supplemental Oxygen While Hospitalized
timeFrame: Approximately 7 months
measure: Proportion of Participants Who Received Mechanical Ventilation While Hospitalized
timeFrame: Approximately 7 months
measure: Proportion of Participants With Missed Doses of Palivizumab
timeFrame: Approximately 7 months
measure: Proportion of Participants With Co-morbidities During Hospitalizations
timeFrame: Approximately 7 months
measure: Median Duration of Mechanical Ventilation Administration During Hospitalizations
timeFrame: Approximately 7 months
measure: Median Duration of Oxygen Administration During Hospitalizations
timeFrame: Approximately 7 months
measure: Proportion of Participants With a Particular Co-morbidity
timeFrame: Approximately 7 months
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Andrey Strugovschikov, MD
role: STUDY_DIRECTOR
References: