Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis
31 de agosto de 2021 atualizado por: National Jewish Health
Cystic fibrosis (CF) is the most common inherited disease in the western world.
On a yearly basis, 56% of CF patients, or nearly 17,000 individuals in the US, suffer from acute pulmonary exacerbations (APE).
The purpose of this study is to test a candidate assay for its ability to diagnose APE, the most important disease event in CF.
While previous studies have been able to identify biomarkers of CF prognosis and risk stratification, three markers have demonstrated characteristics ideal for APE diagnosis: CD64, TLR2, and GILT.
CD64 is a cellular receptor, expressed on numerous cells of the immune system, whose role is to bind antibodies which are attached to infected cells or pathogens.
TLR2 plays a major role in early host-microbial interactions.
GILT has been shown to be more precise in targeting immune responses against antigens and influences T lymphocyte response.
This study looks to identify the differences in the expression of neutrophil CD64 and CD4+ T cell TLR2 and GILT between acute illness and baseline health as a sensitive marker of acute pulmonary exacerbation so that it may facilitate rapid hematologic diagnosis of the condition.
The study also looks to compare sensitivity and specificity of the assays above to standard measures, such as health related quality of life scores (CFQ-R), loss of lung function, white blood cell counts and CRP, for diagnosing acute exacerbations.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
150
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Colorado
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Denver, Colorado, Estados Unidos, 80206
- National Jewish Health
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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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
CF patients aged 18 years or older at the time of an acute pulmonary exacerbation or at baseline health who are followed by the Adult CF Program at National Jewish Health will be eligible to enroll in this study.
Descrição
Inclusion Criteria:
- Documented diagnosis of CF.
- Age 18 years old or greater.
- Presentation at baseline health OR at the start of treatment for a pulmonary exacerbation of CF.
- Ability to perform reproducible Pulmonary Function Tests
- Ability to produce sputum.
- Willingness to complete a health-related quality of life questionnaire
- Willingness to comply with study procedure and provide written consent.
Exclusion Criteria:
• Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or the quality of the data.
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 |
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Acute Pulmonary Exacerbation (APE)
Those subjects presenting with APE will be treated with at least two pathogen specific I.V. antibiotics, as dictated by their treating physician and compliant with standard guidelines for care of an APE.
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Baseline Health
Those subjects presenting at baseline health will be identified by their treating physician as such and will not be starting on any treatments for APE.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Difference in neutrophil CD64 expression
Prazo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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The primary outcome measure is the difference in expression of neutrophil CD64 as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Difference in CD4+ T cell TLR2 expression
Prazo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
|
The primary outcome measure is the difference in expression of CD4+ T cell TLR2 as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Difference in GILT expression
Prazo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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The primary outcome measure is the difference in expression of GILT as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Correlation of primary outcome measurements with lung function tests
Prazo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with changes in FEV1 as measured by spirometry.
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Correlation of primary outcome measurements with C-Reactive Protein
Prazo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in C-Reactive Protein (CRP)
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Correlation of primary outcome measurements with total white blood cell counts
Prazo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in total white blood cell counts (WBC).
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Correlation of primary outcome measurements with sputum inflammatory markers
Prazo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in sputum inflammatory markers as measured by sputum neutrophil counts and neutrophil elastase expression.
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Correlation of primary outcome measurements with phagocytosis
Prazo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in the percentage of phagocytosis by isolated neutrophils.
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Correlation of primary outcome measurements with quality of life questionnaire score
Prazo: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
|
A secondary outcome measure is the correlation of the differences in expression of neutrophil CD64, CD4+ T cell TLR2, and GILT with differences in patient reported health related quality of life scores as measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R).
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Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 (Real)
10 de setembro de 2014
Conclusão Primária (Real)
23 de maio de 2019
Conclusão do estudo (Real)
31 de agosto de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
18 de maio de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de maio de 2020
Primeira postagem (Real)
21 de maio de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de setembro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de agosto de 2021
Última verificação
1 de agosto de 2021
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 14BGF-10
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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