Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis
31 août 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
150
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Colorado
-
Denver, Colorado, États-Unis, 80206
- National Jewish Health
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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.
|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in neutrophil CD64 expression
Délai: 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 neutrophil CD64 as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
|
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
|
|
Difference in CD4+ T cell TLR2 expression
Délai: 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).
|
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
|
|
Difference in GILT expression
Délai: 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 GILT as measured by flow cytometry from circulating blood between the two groups (APE and baseline).
|
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Correlation of primary outcome measurements with lung function tests
Délai: 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 changes in FEV1 as measured by spirometry.
|
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
|
|
Correlation of primary outcome measurements with C-Reactive Protein
Délai: 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 C-Reactive Protein (CRP)
|
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
|
|
Correlation of primary outcome measurements with total white blood cell counts
Délai: 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 total white blood cell counts (WBC).
|
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
|
|
Correlation of primary outcome measurements with sputum inflammatory markers
Délai: 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 sputum inflammatory markers as measured by sputum neutrophil counts and neutrophil elastase expression.
|
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
|
|
Correlation of primary outcome measurements with phagocytosis
Délai: 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 the percentage of phagocytosis by isolated neutrophils.
|
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
|
|
Correlation of primary outcome measurements with quality of life questionnaire score
Délai: 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).
|
Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 septembre 2014
Achèvement primaire (Réel)
23 mai 2019
Achèvement de l'étude (Réel)
31 août 2021
Dates d'inscription aux études
Première soumission
18 mai 2020
Première soumission répondant aux critères de contrôle qualité
18 mai 2020
Première publication (Réel)
21 mai 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 septembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 août 2021
Dernière vérification
1 août 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 14BGF-10
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .