Actively Recruiting
Streamlined Treatment of Pulmonary Exacerbations in Pediatrics
Led by University of Washington, the Collaborative Health Studies Coordinating Center · Updated on 2026-05-14
430
Participants Needed
33
Research Sites
221 weeks
Total Duration
On this page
Sponsors
U
University of Washington, the Collaborative Health Studies Coordinating Center
Lead Sponsor
C
Cystic Fibrosis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Streamlined Treatment of Pulmonary Exacerbations in Pediatrics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For main and non-HEMT cohorts: age 6 to under 19 years
- For preschool cohort: age 3 to under 6 years
- Diagnosis of cystic fibrosis with clinical features and either sweat chloride ≥ 60 mEq/liter or two disease-causing CFTR gene variants
- Written informed consent and ability to comply with study requirements
- For main and preschool cohorts: taking highly effective modulator therapy for at least 3 months at enrollment
- For non-HEMT cohort: not eligible for HEMT or not taking it for at least 3 months with no plans to start, and not taking tezacaftor-ivacaftor or lumacaftor-ivacaftor for at least 3 months
- For main and non-HEMT cohorts: able to perform acceptable and reproducible spirometry
- For main and non-HEMT cohorts: percent predicted FEV1 ≥ 50% at enrollment
- Ability to receive text messages and access the internet
You will not qualify if you...
- Any condition that may compromise safety or data quality as judged by the investigator
- Receiving acute oral or IV antibiotics at enrollment or within 14 days prior; may rescreen 21 days after antibiotic completion if at baseline health
- Treatment with systemic corticosteroids at enrollment or within 14 days prior; may rescreen 21 days after completion if at clinical baseline
- History of solid organ transplant
- Positive culture for Mycobacterium abscessus in the 12 months prior
- Treatment with antibiotics for non-tuberculous mycobacteria at enrollment
- Three or more IV antibiotic-treated pulmonary exacerbations in the 12 months prior
- Treatment with chronic oral antibiotics other than azithromycin at enrollment
- Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis in the 12 months prior
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
The Children's Hospital Alabama & University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Tucson Cystic Fibrosis Center
Tucson, Arizona, United States, 85713
Actively Recruiting
3
Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis Clinic
Los Angeles, California, United States, 90027
Actively Recruiting
4
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
5
Rady Children's Hospital at University of California San Diego
San Diego, California, United States, 92123
Not Yet Recruiting
6
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Children's Healthcare of Atlanta & Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University
Chicago, Illinois, United States, 60611
Not Yet Recruiting
9
Riley Hospital for Children & Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
11
Johns Hopkins Hospital, Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
12
Boston Children's Hospital & Harvard University
Boston, Massachusetts, United States, 02115
Actively Recruiting
13
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109-5212
Actively Recruiting
14
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
15
The Minnesota Cystic Fibrosis Center & University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
16
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
17
St. Louis Children's Hospital & Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
18
University of Rochester Medical Center Strong Memorial
Rochester, New York, United States, 14642
Actively Recruiting
19
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
20
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
21
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Actively Recruiting
22
Children's Hospital of Philadelphia & University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
23
Children's Hospital of Pittsburgh of UPMC & University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
24
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
25
University of Texas Southwestern & Children's Health
Dallas, Texas, United States, 75235
Actively Recruiting
26
Texas Children's Hospital & Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
27
Vermont Children's Hospital & University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
28
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
29
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
30
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
31
Children's Wisconsin & Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
32
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Actively Recruiting
33
The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics
Toronto, Ontario, Canada, M5G 0A4
Actively Recruiting
Research Team
E
Erika Enright
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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