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 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT02295566
Eligibility Criteria:
Inclusion Criteria:
* Adolescents and young adults with cystic fibrosis aged 12 or above
* Colonised with Pseudomonas aeruginosa (confirmed on sputum sample)
Exclusion Criteria:
* Colonisation with Burkholderia cepacia
* Known hypersensitivity to the antibiotics used in the study
* Other known contraindications to the antibiotics to be used in the study including known aminoglycoside related hearing/renal damage
* Patients requiring non-invasive ventilation (NIV)
* Patients who have a pneumothorax
* Patients who are admitted for specific treatment of nontuberculous mycobacteria (NTM)
* Patients who cannot tolerate nasal cannula e.g. those who cannot breathe through their nose
* Patients who have nasal polyposis that is causing significant blockage of the nasal passages
* Adolescents who are not Gillick competent (and therefore not able to give their own assent in addition to parental consent)
* Patients not likely to survive the time period of the study washout period (4 months from enrolment)
* Treatment with an investigational drug or device within the last 3 months prior to enrolment
* Patients who are pregnant (a pregnancy test will be carried out for females of 11 years and above as is standard practice for clinical trials)
* Immediate families of investigators or site personnel directly affiliated with the study. Immediate family is defined as child or sibling, whether biological or legally adopted.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT02295566
Study Brief:
Protocol Section:
NCT02295566