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:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT06595420
Eligibility Criteria:
Inclusion Criteria:
1. Outpatient CF Cohort
* Diagnoses of Cystic Fibrosis
* Age \> 30 years old
* Able to provide informed consent
2. Inpatient CF Cohort
* Diagnoses of Cystic Fibrosis
* Age \> 7 years old
* Able to provide informed consent and assent (where applicable)
* 55 PwCF frequently hospitalized for a pulmonary exacerbation (\>1 hospital admission in the prior 12 months)
* 55 PwCF sporadically hospitalized for a pulmonary exacerbation (no hospital admissions in the prior 12 months)
* Able to provide urine sample independently
3. Healthy Controls
* Healthy, as per participant self-report
* Age between 30-50 years
* Able to provide informed consent
Exclusion Criteria:
1. Outpatient CF Cohort
* History of any organ transplant
* History of immunodeficiency
* Previous or current cancer diagnoses
* Pregnant or breastfeeding
* On chronic dialysis
* Non-compliance (demonstrated by \<2 visits during the 12 months before enrollment)
2. Inpatient CF Cohort
* The initiation of intravenous antibiotic therapy after hospital admission before obtaining the first blood and urine sample
* History of any organ transplant
* History of immunodeficiency
* Previous or current cancer diagnoses
* Pregnant or breastfeeding
* On chronic dialysis
3. Healthy Controls
* History or current kidney disease, organ transplantation, cancer, or any other chronic illness
* Current use of antibiotics
* Urinary symptoms or UTI (dysuria, frequency, urgency)
* Pregnant women
* Menstruating on the study visit day
* Blood relatives of PwCF
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT06595420
Study Brief:
Protocol Section:
NCT06595420