Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT05675592
Eligibility Criteria:
Inclusion Criteria:
* Definite diagnosis of CF and regular follow up, in accordance with the standard operating procedures in force at the Centres
* Homozygous for the F508del mutation (F508del/F508del) in the CFTR gene or heterozygous for the F508del mutation and with a minimal function mutation in the other allele (F508del/minimum function mutation)
* Chronically infected with P. aeruginosa (defined as having at least 50% or more sputum cultures positive for P. aeruginosa in the previous year)
* Candidates starting treatment with Kaftrio or being treated with Kaftrio (retrospective phase)
* Both sexes aged \>12 years
* Obtaining informed consent from patients and/or from patients' parents (according to the modalities foreseen by the protocol)
Exclusion Criteria:
* Patients unable to understand the instructions and information provided and to be able to adequately accept the modalities of the study.
* Patients unable to expectorate.
* Patients with negative sputum for P. aeruginosa at T0, which in the case of prospective patients corresponds to the time of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05675592
Study Brief:
Protocol Section:
NCT05675592