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Treatment options for pulmonary exacerbations in children with cystic fibrosis

Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Randomized Controlled Trial (STOP PEDS RCT)

Not applicable Interventional University of Washington, the Collaborative Health Studies Coordinating Center · NCT06654752

This study is testing two different ways to treat lung flare-ups in kids with cystic fibrosis to see which method works better and helps avoid giving antibiotics when they’re not needed.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment430 (estimated)
Ages3 Years to 18 Years
SexAll
SponsorUniversity of Washington, the Collaborative Health Studies Coordinating Center Academic / other
Locations33 sites (Birmingham, Alabama and 32 other locations)
Trial IDNCT06654752 on ClinicalTrials.gov

What this trial studies

The STOP PEDS RCT is a multicenter, open-label randomized controlled trial that evaluates the safety and efficacy of two antibiotic treatment strategies for managing outpatient pulmonary exacerbations in pediatric patients with cystic fibrosis. Participants aged 3 to 18 will be assigned to either an immediate antibiotics group or a tailored therapy group, where antibiotics are only administered if specific worsening symptoms occur. The study aims to determine the long-term and short-term outcomes of these treatment approaches over a 12-month period, focusing on reducing unnecessary antibiotic exposure while effectively managing exacerbations.

Who should consider this trial

Good fit: Ideal candidates include children aged 3 to 18 years diagnosed with cystic fibrosis who are on highly effective modulator therapy.

Not a fit: Patients who are not eligible for highly effective modulator therapy or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment strategies for managing pulmonary exacerbations in children with cystic fibrosis.

How similar studies have performed: Other studies have shown promise in similar approaches, but this specific trial is designed to evaluate a novel treatment strategy in the pediatric cystic fibrosis population.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

   1. For main cohort and preschool cohort: Taking HEMT for at least 3 months at enrollment
   2. 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
5. For main cohort and non-HEMT cohort: able to perform acceptable and reproducible spirometry
6. For main cohort and non-HEMT cohort: ppFEV1 ≥ 50% predicted at enrollment based on the Global lung Initiative (GLI) reference equations
7. Ability to receive text messages and access the internet

Exclusion Criteria:

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
9. Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis (ABPA) in the 12 months prior to enrollment

Where this trial is running

Birmingham, Alabama and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cystic Fibrosiscystic fibrosisoral antibioticspulmonary exacerbationpediatric
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.