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 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT01694069
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of cystic fibrosis
2. 8 years of age or greater
3. Chronic or intermittent infection with Pseudomonas aeruginosa as defined by the Leeds Criteria
4. Pulmonary exacerbation as defined by Fuchs et al.
Exclusion Criteria:
1. Admission for greater than 48 hours prior to enrollment
2. Isolation of Burkholderia spp. in a respiratory tract culture in the prior 12 months
3. Current treatment for allergic bronchopulmonary aspergillosis
4. Pregnant or breast feeding
5. History of solid organ transplantation
6. Renal impairment at time of randomization (\< 40 mL/min as calculated by the Cockcroft-Gault equation24 ¬for adults or the Schwartz equation45 for those \< 18 years of age) or receipt of hemodialysis
7. Allergy to study medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT01694069
Study Brief:
Protocol Section:
NCT01694069