Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis
31. august 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
150
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Colorado
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Denver, Colorado, Forente stater, 80206
- National Jewish Health
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Difference in neutrophil CD64 expression
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Correlation of primary outcome measurements with lung function tests
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. september 2014
Primær fullføring (Faktiske)
23. mai 2019
Studiet fullført (Faktiske)
31. august 2021
Datoer for studieregistrering
Først innsendt
18. mai 2020
Først innsendt som oppfylte QC-kriteriene
18. mai 2020
Først lagt ut (Faktiske)
21. mai 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2021
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14BGF-10
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