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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT00360503
Eligibility Criteria:
Inclusion Criteria:
* \> 6 years of age.
* Documented sweat chloride greater than 60 mEq/mL by quantitative pilocarpine iontophoresis test or homozygous for deltaF508 genetic mutation (or heterozygous for two well-characterized mutations) and one or more clinical features consistent with CF.
* Most recent FEV1 between 25% and 75% predicted when clinically stable; must be obtained at or within 3 months prior to study visit.
* P. aeruginosa present in the most recent sputum or throat culture obtained within 6 months prior to study visit.
* Able to expectorate sputum on a routine basis.
* Written informed consent provided.
Exclusion Criteria:
* Administration of any anti-pseudomonal antibiotics by any route within 14 days prior to study visit.
* Participation in a research protocol that potentially involves antibiotic treatment within 14 days prior to study visit.
* Requiring treatment with intravenous or inhaled anti-pseudomonal antibiotics at study visit.
* B. cepacia complex present in the most recent sputum or throat culture obtained within 6 months prior to study visit.
* Post lung transplantation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT00360503
Study Brief:
Protocol Section:
NCT00360503