Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis
31. August 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
150
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Colorado
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Denver, Colorado, Vereinigte Staaten, 80206
- National Jewish Health
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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
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
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.
Beschreibung
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.
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 |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Difference in neutrophil CD64 expression
Zeitfenster: 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
Zeitfenster: 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 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Correlation of primary outcome measurements with lung function tests
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
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 (Tatsächlich)
10. September 2014
Primärer Abschluss (Tatsächlich)
23. Mai 2019
Studienabschluss (Tatsächlich)
31. August 2021
Studienanmeldedaten
Zuerst eingereicht
18. Mai 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. Mai 2020
Zuerst gepostet (Tatsächlich)
21. Mai 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
2. September 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
31. August 2021
Zuletzt verifiziert
1. August 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 14BGF-10
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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