NCT05937815 Intestine-lung Axis of Cystic Fibrosis Patients Treated With the Combination Elexacaftor/Tezacaftor/Ivacaftor
| NCT ID | NCT05937815 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Cystic Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 253 participants |
| Start Date | 2021-09-13 |
| Primary Completion | 2026-09-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 253 participants in total. It began in 2021-09-13 with a primary completion date of 2026-09-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cystic fibrosis is a systemic disease, which affects in particular the respiratory and digestive systems of patients, sites of chronic inflammation. A new combination of elexacaftor/tezacaftor/ivacaftor has proven its efficacy for the treatment of patients aged 12 years and over with two F508del mutations or a so-called "minimal function" mutation associated with one F508del mutation. European marketing authorization was obtained in August 2020 and access in France should therefore arrive soon. Given that this treatment targets new mutations and that the efficacy seems greater than with LUM/IVA, it is important to assess its impact on the microbiota and the pulmonary and digestive inflammation of patients. It is therefore a question of taking advantage of the experience of the Lum-Iva-Biota cohort, and the validated and operational sample circuit established in the various participating centers to set up a biological collection for the collection and storage of sputum and stools of patients during the first year of treatment with elexacaftor/tezacaftor/ivacaftor, in order to study the effect of treatment on the lung and digestive microbiota/mycobiota and inflammation.
Eligibility Criteria
Inclusion Criteria: * To have cystic fibrosis (sweat test \> 60 mmol/l); * Carrier of at least one DeltaF508 mutation; * Be followed in the current care by a participant in the CRCM study; * Start treatment with elexacaftor/tezacaftor/ivacaftor in routine care, according to the indications in the Marketing Authorization at the time of inclusion; * Be of the age specified in the marketing authorization in force; * Person affiliated or beneficiary of a social security scheme; * Consent obtained by the patient (for adult patients) or the holders of parental authority (for minor patients) before any examination required by the research and oral and/or written consent by the participant (depending on his or her age) . * Patient agreeing to take part in cohort follow-up studies of patients treated with elexacaftor/tezacaftor/ivacaftor, included in the French cystic fibrosis register (cf. Study by Pr BURGEL and/or MODUL CF). Exclusion Criteria: * Start of treatment with elexacaftor/tezacaftor/ivacaftor as part of a therapeutic trial. * Patient already on CFTR modulator (including lumacaftor/ivacaftor) * Vulnerable people (pregnant woman, person under guardianship/curators)
Contact & Investigator
Raphaël Enaud, MDPhD
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT05937815 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05937815 currently recruiting?
Yes, NCT05937815 is actively recruiting participants. Contact the research team at aurore.capelli@chu-bordeaux.fr for enrollment information.
Where is the NCT05937815 trial being conducted?
This trial is being conducted at Bordeaux, France, Grenoble, France, Lille, France, Limoges, France and 11 additional locations.
Who is sponsoring the NCT05937815 clinical trial?
NCT05937815 is sponsored by University Hospital, Bordeaux. The principal investigator is Raphaël Enaud, MDPhD at University Hospital, Bordeaux. The trial plans to enroll 253 participants.