RecruitingCystic Fibrosis

Streamlined Treatment of Pulmonary Exacerbations in Pediatrics

Eligible age

3–18 yrs

Accepts

All genders

Locations

24 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

The STOP PEDS RCT is a multicenter, parallel, open label randomized controlled trial evaluating the long-term (one year) and short-term safety and efficacy of two antibiotic treatment strategies for the management of outpatient pulmonary exacerbations (PEx) in the pediatric CF population.

Sponsor: University of Washington, the Collaborative Health Studies Coordinating Center

You may qualify if…

✓ 1. Age
✓ 1. For main cohort and non-HEMT cohort: age 6 to \<19 years
✓ 2. For preschool cohort: age 3 to \<6 years
✓ 2. 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
✓ 2. two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
✓ 3. Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability of participant to comply with the requirements of the study
✓ 4. Highly Effective Modulator Therapy

You may not qualify if…

✕ 1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the data
✕ 2. Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be re-screened ≥21 days after completion of antibiotics if they are at their baseline state of health, per self-report
✕ 3. Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after completion of systemic corticosteroids if they are at their clinical baseline, per self-report
✕ 4. History of solid organ transplant
✕ 5. History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment
✕ 6. Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment
✕ 7. Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment
✕ 8. Treatment with chronic oral antibiotics other than azithromycin at enrollment