Pharmacokinetics of Antibiotics in CF Patients on ETI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will prospectively measure plasma antibiotic concentrations and pharmacokinetic parameters in CF patients who are on elexacaftor/tezacaftor/ivacaftor (ETI) and require antibiotics for pulmonary exacerbations or respiratory infections. It will compare measured antibiotic exposure to established targets to understand if ETI alters absorption, distribution, metabolism, or elimination of antibiotics in this population. No active intervention is assigned; data are collected in the course of routine care. The goal is to determine whether ETI changes antibiotic PK/PD in order to optimize dosing for CF patients. Enrollment requires CF confirmed diagnosis, ongoing ETI therapy for at least 3 months, age 12 or older, and clinical need for antibiotics for a pulmonary flare.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of cystic fibrosis confirmed by sweat test and/or genetic testing
* Treatment with elexacaftor/tezacaftor/ivacaftor (ETI) for at least 3 months
* Age 12 years or older
* Patient informed and not objecting to participation; for minors, parents/legal guardians informed and not objecting to participation
* Clinical indication for antibiotic therapy for pulmonary exacerbation or respiratory infection according to treating physician
* Affiliation to a social security system

Exclusion Criteria:

* Lung transplantation or heart-lung transplantation
* Patients under guardianship or curatorship
* Pregnant or breastfeeding women

Where it's running

• Fondation ILDYS
  Roscoff, France Recruiting

Study contacts

• Study coordinator: Marion Buyse, PharmD, PhD
• Email: marion.buyse@ildys.org
• Phone: +33298293447

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.