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 de junho de 2016 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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 de estudo
Observacional
Inscrição (Real)
359
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
Não mais velho que 1 ano (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Infants at high-risk of serious RSV illness
Infants who received immunoprophylaxis during the RSV season
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Approximately 7 months
|
The median duration of mechanical ventilation administration during hospitalizations was calculated.
|
Approximately 7 months
|
|
Median Duration of Oxygen Administration During Hospitalizations
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Andrey Strugovschikov, MD, AbbVie
Publicações e links úteis
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de outubro de 2014
Conclusão Primária (Real)
1 de maio de 2015
Conclusão do estudo (Real)
1 de maio de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
3 de novembro de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de novembro de 2014
Primeira postagem (Estimativa)
5 de novembro de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
29 de julho de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de junho de 2016
Última verificação
1 de junho de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- P14-579
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