Informations générales (source: ClinicalTrials.gov)
Monitoring of the Intestine-lung Axis of Cystic Fibrosis Patients Treated With the Combination Elexacaftor/Tezacaftor/Ivacaftor: Study of the Pulmonary and Gut Microbiota and Inflammation (KAF-BIOTA)
Interventional
N/A
University Hospital, Bordeaux (Voir sur ClinicalTrials)
septembre 2021
septembre 2024
05 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Cochin | Pierre-Régis BURGEL | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Necker-Enfants Malades | Isabelle Sermet Gaudelus | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM CRCM pédiatrique - Marseille - France | Jean-Christophe Dubus | Contact (sur clinicalTrials) | |||
| AP-HP CRCM Robert debré - Paris - France | Michèle GERARDIN | Contact (sur clinicalTrials) | |||
| CHRU de Lille CRCM Pédiatrique - Lille - France | Nathalie Wizla | Contact (sur clinicalTrials) | |||
| CHU de Bordeaux - CRCM pédiatrique - Bordeaux - France | Raphaël ENAUD | Contact (sur clinicalTrials) | |||
| CHU de Grenoble Alpes CRCM pédiatrique - Grenoble - France | Catherine LLerena | Contact (sur clinicalTrials) | |||
| CHU de Limoges CRCM Limousin - Limoges - France | Alexandra Masson-Rouchaud | Contact (sur clinicalTrials) | |||
| CHU de Montpellier - Montpellier - France | Raphael CHIRON | Contact (sur clinicalTrials) | |||
| CHU de Nancy - Nancy - France | Aurélie Tatopoulos | Contact (sur clinicalTrials) | |||
| CHU de Nice - Nice - France | Sylvie Leroy | Contact (sur clinicalTrials) | |||
| CHU de Rouen - Rouen - France | Hélène Morisse Pradier | Contact (sur clinicalTrials) | |||
| CHU de Toulouse - Toulouse - France | Marie Mittaine | Contact (sur clinicalTrials) | |||
| Fondation Ildys, Roscoff Centre Hélio Marin - Clinique "Mucoviscidose" - Roscoff - France | Sophie RAMEL | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon Service de pédiatrie, allergologie et mucoviscidose - Lyon - France | Philippe Reix | Contact (sur clinicalTrials) | |||
Critères
Tous
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).
- 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).
- 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)