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Could a single antibiotic be enough for cystic fibrosis lung infections?

NCT ID NCT05548283

Disease control Sponsor: Chris Goss 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study looks at people with cystic fibrosis who need intravenous antibiotics for a sudden worsening of lung symptoms (called a pulmonary exacerbation). It compares treatment with one type of antibiotic (beta-lactam) versus two types (beta-lactam plus an aminoglycoside like tobramycin). The goal is to see if using just one antibiotic works as well as two, which could mean fewer side effects and simpler treatment. The study involves 730 participants aged 6 and older and measures lung function and symptom improvement over several weeks.

What this could mean

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

Active substance
beta-lactam antibiotic and aminoglycoside (tobramycin)
What this could lead to
If one antibiotic works as well as two, it could simplify treatment for cystic fibrosis lung flare-ups, reducing side effects and drug burden.
What could go wrong
This is a Phase 4 study, so the drugs are already approved, but it may find that two antibiotics are still needed for best outcomes. Side effects from aminoglycosides include kidney and hearing issues.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 730 people

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

Started

Apr 2023

Expected to finish

May 2027

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

6 years and older

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: * All genders ≥ 6 years of age at Visit 1 * Documentation of a CF diagnosis * Clinician intent to treat index CF PEx with a planned 14-day course of IV antimicrobials * At least one documented Pa positive culture within two years prior to Visit 1 Exclusion Criteria: * Participant is not pregnant * No known renal impairment or history of solid organ transplantation * No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks prior to Visit 1 * No use of investigational therapies, new CF transmembrane conductance regulator (CFTR) modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior to Visit 1 * No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides * No more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1

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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 Cystic fibrosis pulmonary exacerbation

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

  • All Children's Hospital

    RECRUITING

    St. Petersburg, Florida, 33701, United States

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

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Billings Clinic

    RECRUITING

    Billings, Montana, 59101, United States

  • Boston Children's Hospital, Brigham & Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CHOC Children's Hospital

    RECRUITING

    Orange, California, 92868, United States

  • Children's Hospital Medical Center of Akron

    RECRUITING

    Akron, Ohio, 44308, United States

  • Children's Hospital of New York

    RECRUITING

    New York, New York, 10032, United States

  • Children's Hospital of Pittsburgh of UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's National Medical Center

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Cook Children's Medical Center

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Dayton Children's Hospital

    RECRUITING

    Dayton, Ohio, 45404, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30327, United States

  • Helen DeVos Children's Hospital

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Indiana University Medical Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Joe DiMaggio Children's Hospital

    RECRUITING

    Hollywood, Florida, 33021, United States

  • John Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Lenox Hill Hospital Cystic Fibrosis Center

    RECRUITING

    New York, New York, 10003, United States

  • Long Beach Memorial Medical Center

    RECRUITING

    Long Beach, California, 90806, United States

  • Maine Medical Center

    RECRUITING

    Portland, Maine, 04102, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Nemours Children's Clinic

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • New York Medical College at Westchester Medical Center

    RECRUITING

    Valhalla, New York, 10595, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • OSF Saint Francis Medical Center

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Oklahoma Cystic Fibrosis Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

    Contact Email: •••••@•••••

  • Oregon Health Sciences University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Providence Medical Group, Cystic Fibrosis Clinic

    RECRUITING

    Spokane, Washington, 99204, United States

  • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44146, United States

    Contact Email: •••••@•••••

  • Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Rutgers - Robert Wood Johnson Medical School

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • SSM Health Cardinal Glennon Children's Hospital

    RECRUITING

    St Louis, Missouri, 63104, United States

  • Saint Luke's Cystic Fibrosis Center of Idaho

    RECRUITING

    Boise, Idaho, 83702, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

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

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Toledo Children's Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

  • Tucson Cystic Fibrosis Center

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB)

    RECRUITING

    Calgary, Alberta, T2N4N1, Canada

  • University of California San Diego

    RECRUITING

    La Jolla, California, 92093, United States

  • University of California at Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Massachusetts Memorial Health Care

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan, Michigan Medicine

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Southwestern

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Texas Southwestern / Children's Health

    RECRUITING

    Dallas, Texas, 75207, United States

  • University of Washington Medical Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Vanderbilt Children's Hospital

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • West Virginia University - Morgantown

    RECRUITING

    Morgantown, West Virginia, 26507, United States

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