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RECRUITING

NCT06654752

Streamlined Treatment of Pulmonary Exacerbations in Pediatrics

Sponsor: University of Washington, the Collaborative Health Studies Coordinating Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

430

Start Date

2024-12-01

Completion Date

2029-02-28

Last Updated

2026-03-10

Healthy Volunteers

Conditions

Cystic Fibrosis

Interventions

OTHER

Immediate Oral Antibiotics

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

OTHER

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

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

Locations (33)

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

Birmingham, Alabama, United States

Tucson Cystic Fibrosis Center

Tucson, Arizona, United States

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

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

Rady Children's Hospital at University of California San Diego

San Diego, California, United States

Children's Hospital of Colorado

Aurora, Colorado, United States

Children's Healthcare of Atlanta & Emory University

Atlanta, Georgia, United States

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

Chicago, Illinois, United States

Riley Hospital for Children & Indiana University

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Johns Hopkins Hospital, Johns Hopkins University

Baltimore, Maryland, United States

Boston Children's Hospital & Harvard University

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States

The Minnesota Cystic Fibrosis Center & University of Minnesota

Minneapolis, Minnesota, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

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

St Louis, Missouri, United States

University of Rochester Medical Center Strong Memorial

Rochester, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Children's Hospital of Philadelphia & University of Pennsylvania

Philadelphia, Pennsylvania, United States

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

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Southwestern & Children's Health

Dallas, Texas, United States

Texas Children's Hospital & Baylor College of Medicine

Houston, Texas, United States

Vermont Children's Hospital & University of Vermont Medical Center

Burlington, Vermont, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Children's Wisconsin & Medical College of Wisconsin

Milwaukee, Wisconsin, United States

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics

Toronto, Ontario, Canada