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 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
359
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
Nicht älter als 1 Jahr (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
Infants at high-risk of serious RSV illness
Infants who received immunoprophylaxis during the RSV season
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Approximately 7 months
|
The median duration of mechanical ventilation administration during hospitalizations was calculated.
|
Approximately 7 months
|
|
Median Duration of Oxygen Administration During Hospitalizations
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Andrey Strugovschikov, MD, AbbVie
Publikationen und hilfreiche Links
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Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Oktober 2014
Primärer Abschluss (Tatsächlich)
1. Mai 2015
Studienabschluss (Tatsächlich)
1. Mai 2015
Studienanmeldedaten
Zuerst eingereicht
3. November 2014
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
3. November 2014
Zuerst gepostet (Schätzen)
5. November 2014
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
29. Juli 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. Juni 2016
Zuletzt verifiziert
1. Juni 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- P14-579
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