NCT07629986Recruiting
Pharmacokinetics of Antibiotics in Patients With Cystic Fibrosis Trated With Elexacaftor/Tezacaftor/Ivacaftor (ETI)
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 15 May 2026
- Start date
- 19 Mar 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- Fondation Ildys
- Diseases
- Cystic fibrosis
- NCT number
- NCT07629986
What you commit to
- Study type: Observational
- Planned participants: 30
- From 19 Mar 2026 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Lung transplantation or heart-lung transplantation
Other
- Patients under guardianship or curatorship
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondation ILDYS Coordinator of this site? Confirm its status | Roscoff | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.