Cystic FibrosisNCT04397809
Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by National Jewish Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2014to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in neutrophil CD64 expression
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).
Measured: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Difference in CD4+ T cell TLR2 expression
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).
Measured: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Difference in GILT expression
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).
Measured: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Secondary outcomes (6)
Correlation of primary outcome measurements with lung function tests
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.
Measured: 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
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)
Measured: 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
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).
Measured: 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
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.
Measured: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Correlation of primary outcome measurements with phagocytosis
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.
Measured: 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
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).
Measured: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start10 Sep 2014
- Primary completion23 May 2019
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397809
- Sponsor's protocol ID
- 14BGF-10
- Status last verified
- Aug 2021
- First submitted
- 18 May 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04397809
- Acronym / sponsor ID
- 14BGF-10
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- 10 Sep 2014 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in neutrophil CD64 expression
Time frame: 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).
Difference in CD4+ T cell TLR2 expression
Time frame: 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).
Difference in GILT expression
Time frame: 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).
6 secondary outcomes
Correlation of primary outcome measurements with lung function tests
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Correlation of primary outcome measurements with phagocytosis
Time frame: 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
Time frame: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in neutrophil CD64 expression (time frame: Within 24 hours of initiation of IV antibiotic treatment for CF pulmonary exacerbation or at Baseline health). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.