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.
Age
For main cohort and non-HEMT cohort: age 6 to <19 years
For preschool cohort: age 3 to <6 years
sweat chloride ≥ 60 mEq/liter
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
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
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
History of solid organ transplant
University of Washington, the Collaborative Health Studies Coordinating Center
Lead sponsor
Cystic Fibrosis Foundation
Collaborator