Streamlined Treatment of Pulmonary Exacerbations in Pediatrics

Recruiting now · Not applicable

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT06654752

Run by

University of Washington, the Collaborative Health Studies Coordinating Center

People needed

430

Starts

2024-12-01

Expected to finish

2029-02-28

Last updated by the study team

2026-08-03

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age
• For main cohort and non-HEMT cohort: age 6 to <19 years
• For preschool cohort: age 3 to <6 years
• 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:
• sweat chloride ≥ 60 mEq/liter
• two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
• 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
• Highly Effective Modulator Therapy
• For main cohort and preschool cohort: Taking HEMT for at least 3 months at enrollment
• For non-HEMT cohort: not eligible for HEMT based on CFTR genotype or eligible but not taking for at least 3 months and no plans to start HEMT in the next year, and also not taking tezacaftor-ivacaftor or lumacaftor-ivacaftor for at least 3 months
• For main cohort and non-HEMT cohort: able to perform acceptable and reproducible spirometry
• For main cohort and non-HEMT cohort: ppFEV1 ≥ 50% predicted at enrollment based on the Global lung Initiative (GLI) reference equations
• Ability to receive text messages and access the internet

You may not qualify if…

• 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
• History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment
• Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment
• Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment
• Treatment with chronic oral antibiotics other than azithromycin at enrollment
• Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis (ABPA) in the 12 months prior to enrollment

Where it is running

• The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics — Toronto, Ontario, Canada (enrolling)
• Tucson Cystic Fibrosis Center — Tucson, Arizona, United States (enrolling)
• Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis Clinic — Los Angeles, California, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• The Children's Hospital Alabama & University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Children's Hospital of Colorado — Aurora, Colorado, United States (enrolling)
• Children's Healthcare of Atlanta & Emory University — Atlanta, Georgia, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University — Chicago, Illinois, United States (enrolling)
• Riley Hospital for Children & Indiana University — Indianapolis, Indiana, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Johns Hopkins Hospital, Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Boston Children's Hospital & Harvard University — Boston, Massachusetts, United States (enrolling)
• University of Michigan Health System — Ann Arbor, Michigan, United States (enrolling)
• Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• The Minnesota Cystic Fibrosis Center & University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Children's Mercy Hospital — Kansas City, Missouri, United States (enrolling)
• St. Louis Children's Hospital & Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• University of Rochester Medical Center Strong Memorial — Rochester, New York, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• Children's Hospital of Philadelphia & University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Children's Hospital of Pittsburgh of UPMC & University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• University of Texas Southwestern & Children's Health — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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