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 giugno 2016 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
359
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Non più vecchio di 1 anno (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
|---|
|
Infants at high-risk of serious RSV illness
Infants who received immunoprophylaxis during the RSV season
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Approximately 7 months
|
The median duration of mechanical ventilation administration during hospitalizations was calculated.
|
Approximately 7 months
|
|
Median Duration of Oxygen Administration During Hospitalizations
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Andrey Strugovschikov, MD, AbbVie
Pubblicazioni e link utili
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Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 ottobre 2014
Completamento primario (Effettivo)
1 maggio 2015
Completamento dello studio (Effettivo)
1 maggio 2015
Date di iscrizione allo studio
Primo inviato
3 novembre 2014
Primo inviato che soddisfa i criteri di controllo qualità
3 novembre 2014
Primo Inserito (Stima)
5 novembre 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
29 luglio 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 giugno 2016
Ultimo verificato
1 giugno 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- P14-579
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .