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Cystic FibrosisSTOP PEDS RCTNCT06654752

Streamlined Treatment of Pulmonary Exacerbations in Pediatrics

A study testing Immediate Oral Antibiotics and Tailored Treatment: Oral Antibiotics only if Additional Treatment needed in people with Cystic Fibrosis, run by University of Washington, the Collaborative Health Studies Coordinating Center at 33 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 3 to 18 years
Conditions the study is for
Cystic Fibrosis
What is being tested?
Immediate Oral Antibiotics and Tailored Treatment: Oral Antibiotics only if Additional Treatment needed
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
430 participants
Where
33 sitesin 2 countries
Study dates
1 Dec 2024to 28 Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

33 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Erika Enright contact

206-897-1922

eenright@uw.edu

33 sites in 2 countries

United States31 sites, 31 recruiting

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-5212

    Dawn Kruse, dmkruse@med.umich.edu

    Samya Nasr, MD

    Recruiting

  • Children's Healthcare of Atlanta & Emory University

    Atlanta, Georgia, 30322

    Joy Dangerfield, jdanger@emory.edu

    Ajay Kasi, MD

    Recruiting

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045

    Mary Cross, Mary.Cross@childrenscolorado.org

    Jordana Hoppe, MD

    Recruiting

  • Johns Hopkins Hospital, Johns Hopkins University

    Baltimore, Maryland, 21287

    Jamelia Maynard, jmaynar8@jhmi.edu

    Peter Mogayzel, MD, PhD, MBA

    Recruiting

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

    Birmingham, Alabama, 35233

    Valerie Tarn, 205-638-5134, vtarn@uabmc.edu

    Christopher Fowler, MD

    Recruiting

  • Boston Children's Hospital & Harvard University

    Boston, Massachusetts, 02115

    Monica Ulles, monica.ulles@childrens.harvard.edu

    Gregory Sawicki, MD

    Recruiting

  • Vermont Children's Hospital & University of Vermont Medical Center

    Burlington, Vermont, 05401

    Zachary Dichard, Zachary.Dichard@uvmhealth.org

    Thomas Lahiri, MD

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

    Caroline Flowers, CRC, caroline_flowers@med.unc.edu

    Jennifer Goralski, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Sarah Shine, shinesa@musc.edu

    Sylvia E Szentpeter, MD

    Recruiting

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

    Chicago, Illinois, 60611

    Larissa Rugg, lrugg@luriechildrens.org

    Maria Dowell, MD

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Sharon Kadon, RN, BSN, CPN, sharon.kadon@cchmc.org

    Gary McPhail, MD

    Recruiting

  • University of Texas Southwestern & Children's Health

    Dallas, Texas, 75235

    Lindsay Allen, CRC, Lindsay.Allen@utsouthwestern.edu

    Preeti Sharma, MD

    Recruiting

  • Texas Children's Hospital & Baylor College of Medicine

    Houston, Texas, 77030

    Mayel Yepez, Mayel.YepezDonado@bcm.edu

    Fadel Ruiz, MD

    Recruiting

  • Riley Hospital for Children & Indiana University

    Indianapolis, Indiana, 46202

    Misty Thompson, misthomp@iu.edu

    Lisa Bendy, lbendy@iu.edu

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Mary Teresi, mary-teresi@uiowa.edu

    Anthony Fischer, MD

    Recruiting

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

    Jana Lomonte, jblomonte@cmh.edu

    Hugo Escobar, MD

    Recruiting

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

    Los Angeles, California, 90027

    Jared Lopez, BA, jalopez@chla.usc.edu

    Martha McKinney, MD

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    Nikki Cole, BS, RRT, CCRC, ndondlinger@wisc.edu

    Hara Levy, MD

    Recruiting

  • Children's Wisconsin & Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Laura Roth, CCRC, lroth@mcw.edu

    Nicholas Antos, MD

    Recruiting

  • Children's Hospitals and Clinics of Minnesota

    Minneapolis, Minnesota, 55404

    Danniella Balangoy, Danniella.Balangoy@childrensmn.org

    Brooke Moore, MD

    Recruiting

  • The Minnesota Cystic Fibrosis Center & University of Minnesota

    Minneapolis, Minnesota, 55455

    Alyssa Perry, ahperry@umn.edu

    Samuel Goldfarb, MD

    Recruiting

  • Stanford University

    Palo Alto, California, 94304

    Tina Conti, BSRC, RRT, RRT-NPS, C-NPT, tconti@stanford.edu

    Lori WaiHang Lee, MD

    Recruiting

  • Children's Hospital of Philadelphia & University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Matthew Gari, garim@chop.edu

    Erin Donnelly, donnellye4@chop.edu

    Recruiting

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

    Pittsburgh, Pennsylvania, 15224

    Adrienne DeRicco, RN, adrienne.dericco2@upmc.edu

    Daniel Weiner, MD

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239-3098

    Pierce Nusbaum, nusbaum@ohsu.edu

    Kelvin MacDonald, MD

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Aleksander Subotic, CRC, aleksandar.subotic@vcuhealth.org

    Andrew T. Barber, MD

    Recruiting

  • University of Rochester Medical Center Strong Memorial

    Rochester, New York, 14642

    Barbara Johnson, RN, Barbara_johnson@urmc.rochester.edu

    Matthew McGraw, MD

    Recruiting

  • Rady Children's Hospital at University of California San Diego

    San Diego, California, 92123

    Lisa Ramos, CRC, lramosvallejo@health.ucsd.edu

    Kathryn Akong, MD

    Not yet recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Alan Genatossio, 206-987-3317, alan.genatossio@seattlechildrens.org

    Marissa Nelson, CRC, 206-987-3921, marissa.nelsen@seattlechildrens.org

    Recruiting

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

    St Louis, Missouri, 63110

    Emily Schulte, RN, BSN, e.burns@wustl.edu

    Jessica Pittman, MD

    Recruiting

  • Tucson Cystic Fibrosis Center

    Tucson, Arizona, 85713

    Elizabeth (Lisa) Ryan, elizabethryan@arizona.edu

    Cori Daines, MD

    Recruiting

Other trials in United States

Canada2 sites, 2 recruiting

  • The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics

    Toronto, Ontario, M5G 0A4

    Claire Crompton, claire.crompton@sickkids.ca

    Felix Ratjen, MD

    Recruiting

  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3V4

    Ronak S Ravandi, ronak.salamatravandi@bcchr.ca

    Jonathan Rayment, MD

    Recruiting

Other trials in Canada

About this study

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

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.

Read the detailed description

The STOP PEDS pilot study demonstrated that a randomized trial of treatment strategies for mild pulmonary exacerbations (PEx) in children with CF was feasible and that assignment to a tailored therapy arm (defined below) may reduce antibiotic exposure.

Based on the research priorities identified by CF families and clinicians and the results of the pilot study, 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 PEx in the pediatric CF population. The two treatment arms are immediate antibiotics and tailored therapy. In both arms, participants will be instructed to increase airway clearance at the onset of an eligible PEx. In the immediate antibiotics arm, they will also begin 14 days of oral antibiotics preselected by their primary CF providers, while in the tailored therapy they will only begin antibiotics if prespecified criteria for worsening symptoms or failure to improve are met.

The STOP PEDS study will enroll three cohorts. In the main cohort, children ages 6-18 on highly effective modulator therapy (HEMT) will be enrolled when well and followed for 12 months. Participants will be randomly assigned to a treatment arm and maintain that treatment assignment for all subsequent eligible PEx during their 12-month enrollment period. Two additional pilot cohorts, the preschool cohort (children ages 3 to 5 on HEMT) and the non-HEMT cohort (children ages 6-18 not eligible for HEMT), will be enrolled in parallel pilot studies. Participants will enroll when well and be followed through one randomized PEx.

Participants in the STOP PEDS RCT at selected sites will have the opportunity to enroll in optional substudies if eligible. These substudies include:

  • Clinic throat swab substudy
  • Home throat and nasal swab substudy
  • Remote monitoring substudy (Home monitoring of lung function, vital signs, activity and sleep)
Conditions
Cystic Fibrosis
Being tested
Immediate Oral Antibiotics, Tailored Treatment: Oral Antibiotics only if Additional Treatment needed
Keywords
cystic fibrosis, oral antibiotics, pulmonary exacerbation, pediatric
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immediate Oral AntibioticsOther

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

  • Tailored Treatment: Oral Antibiotics only if Additional Treatment neededOther

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

Study groups in NCT06654752
Study groupRoleWhat they receive
Immediate AntibioticsExperimentalIncreased airway clearance plus early initiation of oral antibiotics
Receives: Other: Immediate Oral Antibiotics
Tailored TherapyExperimentalIncreased airway clearance alone, with addition of oral antibiotics for worsening symptoms or failure to improve
Receives: Other: Tailored Treatment: Oral Antibiotics only if Additional Treatment needed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. One-year change in pulmonary function by spirometry-measured ppFEV1

    Compare the difference in pulmonary function between arms by evaluating change in spirometry-measured percent predicted forced expiratory volume (ppFEV1). A spirometry test measures the amount of air a person can forcibly exhale after a deep breath (forced vital capacity, or FVC) and the amount of air they can exhale in one second (forced expiratory volume in one second, or FEV1). A lower measured value compared to the reference value indicates lung disease.

    Measured: 1 year

Secondary outcomes (1)

  1. One-Year change in pulmonary function by LCI

    Compare the difference in pulmonary function between arms by evaluating change in Lung Clearance Index (LCI). LCI increases when there is lung disease, which causes ventilation inhomogeneity. LCI is calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity [FRC]) required to reduce end-tidal nitrogen concentration to 1/40th of the original level.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2024
  2. Study start1 Dec 2024
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
430 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06654752
Sponsor's protocol ID
STOP PEDS RCT
Acronym
STOP PEDS RCT
Status last verified
Jul 2026
First submitted
14 Oct 2024
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sanders DB, Bartz TM, Zemanick ET, Hoppe JE, Hinckley Stukovsky KD, Cogen JD, Bendy L, McNamara S, Enright E, Kime NA, Kronmal RA, Edwards TC, Morgan WJ, Rosenfeld M. A Pilot Randomized Clinical Trial of Pediatric Cystic Fibrosis Pulmonary Exacerbations Treatment Strategies. Ann Am Thorac Soc. 2023 Dec;20(12):1769-1776. doi: 10.1513/AnnalsATS.202303-245OC.

    PubMed 37683122

Questions about this trial

What is this clinical trial studying?

A study testing Immediate Oral Antibiotics and Tailored Treatment: Oral Antibiotics only if Additional Treatment needed in people with Cystic Fibrosis, run by University of Washington, the Collaborative Health Studies Coordinating Center at 33 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erika Enright (206-897-1922, eenright@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

One-year change in pulmonary function by spirometry-measured ppFEV1 (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06654752, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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