Analyzing blood neutrophils in cystic fibrosis patients
Functional and Phenotypic Characteristics of Blood Neutrophils in Cystic Fibrosis
NA · Assistance Publique - Hôpitaux de Paris · NCT04970225
This study is testing how different factors, like infections and treatments, affect the immune cells in the blood of people with cystic fibrosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT04970225 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to investigate the function and characteristics of blood neutrophils in patients with cystic fibrosis (CF). It will assess how chronic infection with Pseudomonas aeruginosa, treatment with CFTR modulators, and acute respiratory exacerbations affect neutrophil phenotype and function. Participants will provide blood samples for analysis, allowing researchers to gain insights into the immune response in CF. The study includes various patient groups based on their CF mutation status and treatment history.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with cystic fibrosis, particularly those with specific genetic mutations and treatment histories.
Not a fit: Patients who are not diagnosed with cystic fibrosis or those under legal protection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of immune responses in cystic fibrosis, potentially leading to improved treatments.
How similar studies have performed: While similar studies have explored neutrophil function in cystic fibrosis, this specific approach focusing on the impact of CFTR modulators and chronic infections is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over the age of 18 who is not under legal protection * Patients with CF according to the diagnostic criteria of the Cystic Fibrosis Foundation including: * 15 patients with severe mutation but not chronically infected with PA and not treated with lumacaftor / ivacaftor * 15 patients homozygous phe508del, chronically infected with PA and not treated with lumacaftor / ivacaftor * 15 patients homozygous phe508del, chronically infected with PA and treated with lumacaftor / ivacaftor * 15 hospitalized patients for respiratory exacerbation * 40 patients initiating Ivacaftor-Tezacaftor-Elexacaftor treatment. * No change in baseline treatment for 15 days (including antibiotic treatment). * Patient affiliated to a social security system * Free, informed and written consent, dated and signed by the patient and the investigator, at the latest on the day of inclusion and before any action required by the study. Exclusion Criteria: * Informed consent impossible to obtain * Involvement in an interventional research protocol in the previous 3 months if exclusion directive was given in this protocol.
Where this trial is running
Paris
- Cochin hospital, AP-HP — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Pierre-Régis BURGEL, MD PHD — APHP
- Study coordinator: Pierre-Régis BURGEL, MD PHD
- Email: pierre-regis.burgel@aphp.fr
- Phone: +33 1 58 41 23 67
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cystic Fibrosis, Blood neutrophils, Pseudomonas aeruginosa, Cystic fibrosis, CFTR modulators, respiratory exacerbation, airway chronic infection