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Could waiting on antibiotics be better for kids with CF?

NCT ID NCT06654752

Disease control Sponsor: University of Washington, the Collaborative Health Studies Coordinating Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 4 times

Summary

This study looks at two ways to treat lung flare-ups in children with cystic fibrosis. One group starts antibiotics right away, while the other only takes them if symptoms don't improve. Researchers will track lung function over a year to see which approach works better. The goal is to find a simpler, more tailored treatment plan.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral antibiotics
What this could lead to
If successful, this could show that starting antibiotics only when symptoms worsen is as safe and effective as immediate treatment, potentially reducing unnecessary antibiotic use.
What could go wrong
This is an open-label study, so results may be biased. The findings may not apply to all children with CF, and the tailored approach might lead to worse lung function in some cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 430 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Boston Children's Hospital & Harvard University

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • British Columbia Children's Hospital

    RECRUITING

    Vancouver, British Columbia, V6H 3V4, Canada

  • Children's Healthcare of Atlanta & Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Children's Hospital of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

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

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia & University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospitals and Clinics of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Children's Mercy Hospital

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Children's Wisconsin & Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Johns Hopkins Hospital, Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239-3098, United States

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

    NOT_YET_RECRUITING

    San Diego, California, 92123, United States

  • Riley Hospital for Children & Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

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

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • Texas Children's Hospital & Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

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

    RECRUITING

    Birmingham, Alabama, 35233, United States

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

    RECRUITING

    Toronto, Ontario, M5G 0A4, Canada

  • The Minnesota Cystic Fibrosis Center & University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Tucson Cystic Fibrosis Center

    RECRUITING

    Tucson, Arizona, 85713, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Michigan Health System

    RECRUITING

    Ann Arbor, Michigan, 48109-5212, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Rochester Medical Center Strong Memorial

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Texas Southwestern & Children's Health

    RECRUITING

    Dallas, Texas, 75235, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States

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

    RECRUITING

    Burlington, Vermont, 05401, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

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