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 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT01400750
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of CF (clinical signs consistent with CF and a sweat chloride \> 60 mEq/l by quantitative pilocarpine iontophoresis and/or two CF causing mutations identified)
* age 0 to 18 years old at time of inclusion
* 'First' or 'new Pa infection' defined as 'first Pa isolation ever' or 'isolation of Pa from the airway (sputum, throat swab or BAL) after a Pa free interval of at least 6 months and documented with at least 3 negative cultures'.
Exclusion Criteria:
* chronic Pa infection defined according to the Leeds criteria\[17\]
* pulmonary exacerbation needing IV AB treatment at time of new Pa isolate
* Pa isolation at time of CF diagnosis
* patient already on an antipseudomonal antibiotic
* interval between positive culture and start of treatment \> 4 weeks.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT01400750
Study Brief:
Protocol Section:
NCT01400750