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)
29. juni 2016 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
359
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 1 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Infants at high-risk of serious RSV illness
Infants who received immunoprophylaxis during the RSV season
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Approximately 7 months
|
The median duration of mechanical ventilation administration during hospitalizations was calculated.
|
Approximately 7 months
|
|
Median Duration of Oxygen Administration During Hospitalizations
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Andrey Strugovschikov, MD, AbbVie
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2014
Primær færdiggørelse (Faktiske)
1. maj 2015
Studieafslutning (Faktiske)
1. maj 2015
Datoer for studieregistrering
Først indsendt
3. november 2014
Først indsendt, der opfyldte QC-kriterier
3. november 2014
Først opslået (Skøn)
5. november 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. juli 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juni 2016
Sidst verificeret
1. juni 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- P14-579
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