Recruiting

Pulmonary Exacerbations

Sponsor:

University of Washington, the Collaborative Health Studies Coordinating Center

Code:

NCT06654752

Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

Interventions

Immediate Oral Antibiotics

Tailored Treatment: Oral Antibiotics only if Additional Treatment needed

Study Details

Brief summary:

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

Cystic Fibrosis

Study ID

NCT06654752

Start date

Dec 1, 2024

Status verified date

Jul, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

430 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate Antibiotics

Increased airway clearance plus early initiation of oral antibiotics

experimental: Tailored Therapy

Increased airway clearance alone, with addition of oral antibiotics for worsening symptoms or failure to improve

Interventions

Immediate Oral Antibiotics

Increase airway clearance and start 14 days of preselected oral antibiotics right away

Tailored Treatment: Oral Antibiotics only if Additional Treatment needed

Increase airway clearance and start preselected oral antibiotics later if symptoms get worse or do not get better according to prespecified criteria

Primary outcome measure

  • One-year change in pulmonary function by spirometry-measured ppFEV1 [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

The Children's Hospital Alabama & University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Principal Investigator:

Christopher Fowler, MD

Tucson Cystic Fibrosis Center

Recruiting

Tucson, Arizona, United States, 85713

Contacts

Elizabeth (Lisa) Ryan

elizabethryan@arizona.edu

Principal Investigator:

Cori Daines, MD

Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis Clinic

Recruiting

Los Angeles, California, United States, 90027

Contacts

Jared Lopez, BA

jalopez@chla.usc.edu

Principal Investigator:

Martha McKinney, MD

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Tina Conti, BSRC, RRT, RRT-NPS, C-NPT

tconti@stanford.edu

Principal Investigator:

Lori WaiHang Lee, MD

Children's Hospital of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Jordana Hoppe, MD

Children's Healthcare of Atlanta & Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Joy Dangerfield

jdanger@emory.edu

Principal Investigator:

Ajay Kasi, MD

Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Maria Dowell, MD

Riley Hospital for Children & Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Misty Thompson

misthomp@iu.edu

Lisa Bendy

lbendy@iu.edu

Principal Investigator:

D. B. Sanders, MD, MS

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Principal Investigator:

Anthony Fischer, MD

Johns Hopkins Hospital, Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Jamelia Maynard

jmaynar8@jhmi.edu

Principal Investigator:

Peter Mogayzel, MD, PhD, MBA

Boston Children's Hospital & Harvard University

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Gregory Sawicki, MD

University of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48109-5212

Contacts

Principal Investigator:

Samya Nasr, MD

Children's Hospitals and Clinics of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Principal Investigator:

Brooke Moore, MD

The Minnesota Cystic Fibrosis Center & University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Alyssa Perry

ahperry@umn.edu

Principal Investigator:

Samuel Goldfarb, MD

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Jana Lomonte

jblomonte@cmh.edu

Principal Investigator:

Hugo Escobar, MD

St. Louis Children's Hospital & Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Emily Schulte, RN, BSN

e.burns@wustl.edu

Principal Investigator:

Jessica Pittman, MD

University of Rochester Medical Center Strong Memorial

Recruiting

Rochester, New York, United States, 14642

Contacts

Principal Investigator:

Matthew McGraw, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Caroline Flowers, CRC

caroline_flowers@med.unc.edu

Principal Investigator:

Jennifer Goralski, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Sharon Kadon, RN, BSN, CPN

sharon.kadon@cchmc.org

Principal Investigator:

Gary McPhail, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239-3098

Contacts

Pierce Nusbaum

nusbaum@ohsu.edu

Principal Investigator:

Kelvin MacDonald, MD

Children's Hospital of Philadelphia & University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Matthew Gari

garim@chop.edu

Erin Donnelly

donnellye4@chop.edu

Principal Investigator:

Clement Ren, MD, MBA

Children's Hospital of Pittsburgh of UPMC & University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Adrienne DeRicco, RN

adrienne.dericco2@upmc.edu

Principal Investigator:

Daniel Weiner, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Sarah Shine

shinesa@musc.edu

Principal Investigator:

Sylvia E Szentpeter, MD

University of Texas Southwestern & Children's Health

Recruiting

Dallas, Texas, United States, 75235

Contacts

Principal Investigator:

Preeti Sharma, MD

Texas Children's Hospital & Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Fadel Ruiz, MD

Vermont Children's Hospital & University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Principal Investigator:

Thomas Lahiri, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Aleksander Subotic, CRC

aleksandar.subotic@vcuhealth.org

Principal Investigator:

Andrew T. Barber, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Principal Investigator:

Margaret Rosenfeld, MD

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Nikki Cole, BS, RRT, CCRC

ndondlinger@wisc.edu

Principal Investigator:

Hara Levy, MD

Children's Wisconsin & Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Laura Roth, CCRC

lroth@mcw.edu

Principal Investigator:

Nicholas Antos, MD

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Contacts

Principal Investigator:

Jonathan Rayment, MD

The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics

Recruiting

Toronto, Ontario, Canada, M5G 0A4

Contacts

Principal Investigator:

Felix Ratjen, MD

More Information

Sponsor

University of Washington, the Collaborative Health Studies Coordinating Center

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • cystic fibrosis
  • oral antibiotics
  • pulmonary exacerbation
  • pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Washington, the Collaborative Health Studies Coordinating Center on 2026-08-03.