Clinical trial NCT04397809: Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis
Official title: Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in neutrophil CD64 expression
timeFrame: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
measure: Difference in CD4+ T cell TLR2 expression
timeFrame: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
measure: Difference in GILT expression
timeFrame: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Secondary outcomes:
measure: Correlation of primary outcome measurements with lung function tests
timeFrame: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
measure: Correlation of primary outcome measurements with C-Reactive Protein
timeFrame: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
measure: Correlation of primary outcome measurements with total white blood cell counts
timeFrame: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
measure: Correlation of primary outcome measurements with sputum inflammatory markers
timeFrame: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
measure: Correlation of primary outcome measurements with phagocytosis
timeFrame: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
measure: Correlation of primary outcome measurements with quality of life questionnaire score
timeFrame: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
References: