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 @ 2:27 PM
Ignite Modification Date:
2025-12-24 @ 2:27 PM
NCT ID:
NCT02354859
Eligibility Criteria:
Inclusion Criteria:
* Greater than or equal to 18 years of age at Screening
* Documented chronic colonization with P. aeruginosa defined as dentification in two sputum or oropharyngeal cultures within the year prior to Day 1
* Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
1. sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
2. two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
3. Abnormal nasal potential difference (NPD; change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)
* FEV1 ≥ 25 % of predicted value at Screening
* Able to expectorate sputum
* Serum liver function tests ≤ 2.5 x upper limit of normal at Screening
* Serum urea nitrogen (BUN) ≤ 1.5 x upper limit of normal at Screening
* Serum creatinine ≤ 2.0 mg/dl and ≤ 1.5 x upper limit of normal at Screening
* Hemoglobin ≥ 9 g/dl, platelets ≥ 100,000/mm3, and white blood cells (WBC)
≥ 4,500/mm3 at Screening
* Ionized calcium ≥ lower limit of normal at Screening
* Written informed consent obtained from subject or subject's legal representative
* Able to communicate with the Investigator and comply with the requirements of the protocol
* If female and of childbearing potential, must have a negative pregnancy test on Day 1 prior to receiving study drug
* If female and of childbearing potential, is willing to use adequate contraception for the duration of the study through Visit 5, as determined by the investigator
* If male and able to father a child, is willing to use adequate contraception for the duration of the study through Visit 5, as determined by the investigator
* Clinically stable with no significant changes in health status within 14 days prior to Day 1
Exclusion criteria:
* Use of inhaled antibiotics within seven days prior to Day 1
* Unable or unwilling to withhold use of chronic inhaled antibiotics through Day 28
* Use of intravenous, inhaled, or oral antibiotics for an acute indication within 14 days prior to Day 1
* Use of bisphosphonates within seven days prior to Day 1
* History of osteoporosis (defined as the most recent dexa scan with a T-score ≤ -2.5 with the dexa scan performed within the five years prior to Screening)
* Lactating female
* Known sensitivity to gallium
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02354859
Study Brief:
Protocol Section:
NCT02354859