NCT07629986 Pharmacokinetics of Antibiotics in Patients With Cystic Fibrosis Trated With Elexacaftor/Tezacaftor/Ivacaftor (ETI)
| NCT ID | NCT07629986 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Ildys |
| Condition | Cystic Fibrosis (CF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2026-03-19 with a primary completion date of 2028-03.
⚠ 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 (CF) is associated with major pharmacokinetic and pharmacodynamic alterations affecting antibiotic exposure, including changes in absorption, distribution, metabolism, and elimination. Historically, these alterations justified the use of higher antibiotic doses in CF patients in order to achieve therapeutic concentrations and improve pulmonary outcomes. The advent of highly effective CFTR modulators, particularly the triple combination elexacaftor/tezacaftor/ivacaftor (ETI), has substantially improved pulmonary function, nutritional status, inflammatory burden, and quality of life in patients with CF. ETI therapy also appears to modify respiratory microbiology and reduce the frequency of pulmonary exacerbations. These clinical and physiological improvements may alter antibiotic pharmacokinetics and pharmacodynamics in patients with CF, potentially making current high-dose antibiotic recommendations less appropriate for some patients. Since repeated exposure to high-dose antibiotics is associated with cumulative toxicities, particularly aminoglycoside-related ototoxicity and nephrotoxicity, reassessment of antibiotic dosing strategies is warranted. The PKCF study is a multicenter, prospective, observational, non-interventional study designed to characterize the pharmacokinetic profiles of intravenous antibiotics administered during pulmonary exacerbations in adolescents and adults with cystic fibrosis receiving ETI therapy.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07629986 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Cystic Fibrosis (CF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07629986 currently recruiting?
Yes, NCT07629986 is actively recruiting participants. Contact the research team at marion.buyse@ildys.org for enrollment information.
Where is the NCT07629986 trial being conducted?
This trial is being conducted at Roscoff, France.
Who is sponsoring the NCT07629986 clinical trial?
NCT07629986 is sponsored by Fondation Ildys. The trial plans to enroll 30 participants.