Cystic FibrosisPhase 4STOP360AGNCT05548283
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
A Phase 4 study testing Beta-lactam antibiotic and Aminoglycoside in people with Cystic Fibrosis and Cystic Fibrosis Pulmonary Exacerbation, run by Chris Goss at 60 sites in 2 countries.
Trial summary
The purpose of this study is to look at pulmonary exacerbations in people with cystic fibrosis (CF) that need to be treated with antibiotics given through a tube inserted into a vein (intravenous or IV). A pulmonary exacerbation is a worsening of respiratory symptoms in people with CF that needs medical intervention. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation
- What is being tested?
- Beta-lactam antibiotic and Aminoglycoside
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 730 participants
- Where
- 60 sitesin 2 countries
- Study dates
- 23 Apr 2023to 31 May 2027
- Phase
- Phase 4
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
60 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
60 sites in 2 countries
United States59 sites, 59 recruiting
- Recruiting
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Michelle Parrish, MParrish@akronchildrens.org
- Recruiting
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, 48109
Dawn Kruse, dmkruse@med.umich.edu
- Recruiting
Emory University
Atlanta, Georgia, 30327
Ashleigh Streby, ashleigh.streby@emory.edu
- Recruiting
John Hopkins Hospital
Baltimore, Maryland, 21205
Jeanne Pinto, jpinto4@jh.edu
- Recruiting
Billings Clinic
Billings, Montana, 59101
Jerimiah Lysinger, JLysinger@billingsclinic.org
- Recruiting
The Children's Hospital Alabama, University of Alabama at Birmingham
Birmingham, Alabama, 35233
Heather Hathorne, hyhathorne@uabmc.edu
- Recruiting
Saint Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, 83702
Lejla Godusevic, godusevl@slhs.org
- Recruiting
Boston Children's Hospital, Brigham & Women's Hospital
Boston, Massachusetts, 02115
Robert Fowler, Robert.fowler@childrens.harvard.edu
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Ashley Warden, jonesash@musc.edu
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Yung Hsuan (Irene) Wu, yhwu@luriechildrens.org
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Rachel Nelson, rachel.nelson@northwestern.edu
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Kelly Thornton, Kelly.Thornton@cchmc.org
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Nicole Hummel, Nicole.Hummel@UCHealth.com
- Recruiting
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44146
Primary RC & Participant Contact General Contact, RainbowCFResearch@UHhospitals.org
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Diana Gilmore, Diana.Gilmore@nationwidechildrens.org
- Recruiting
University of Texas Southwestern / Children's Health
Dallas, Texas, 75207
Mary Klosterman, Mary.Klosterman@UTSouthwestern.edu
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Ashley Keller, Ashley.Keller@UTSouthwestern.edu
- Recruiting
Dayton Children's Hospital
Dayton, Ohio, 45404
Amy Jones, Jonesa11@childrensdayton.org
- Recruiting
Cook Children's Medical Center
Fort Worth, Texas, 76104
Jill Finto, jill.finto@cookchildrens.org
- Recruiting
University of Florida
Gainesville, Florida, 32610
Melissa Lingis, melissa.lingis@peds.ufl.edu
- Recruiting
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49546
Andrew James, andrew.james@corewellhealth.org
- Recruiting
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Norma (Jean) Barton, nbarton@mhs.net
- Recruiting
Indiana University Medical Center
Indianapolis, Indiana, 46202
Lisa Bendy, lbendy@iu.edu
- Recruiting
Riley Hospital for Children
Indianapolis, Indiana, 46202
Lisa Bendy, lbendy@iupui.edu
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Mary Teresi, mary-teresi@uiowa.edu
- Recruiting
Nemours Children's Clinic
Jacksonville, Florida, 32207
Jennifer (Jenn) Gafford, Jennifer.gafford@nemours.org
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Lawrence Scott, lscott2@kumc.edu
- Recruiting
University of California San Diego
La Jolla, California, 92093
Jenna Mielke,, jmielke@health.ucsd.edu
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Barbara A Rodgers, Barbara.A.Rodgers@hitchcock.org
- Recruiting
Long Beach Memorial Medical Center
Long Beach, California, 90806
Marylee Melendrez, mmelendrez@memorialcare.org
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Melissa Thomas, mcthom12@louisville.edu
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53792
Melanie Nelson, mnelson@pediatrics.wisc.edu
- Recruiting
University of Miami
Miami, Florida, 33136
Ylber Whitaker, yiw2@miami.edu
- Recruiting
West Virginia University - Morgantown
Morgantown, West Virginia, 26507
Tammy Clark, tclark@hsc.wvu.edu
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Debra Connolly, Debra.Connolly@atlantichealth.org
- Recruiting
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
Brijesh Patel, brijesh.patel@vumc.org
- Recruiting
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Sheila Redding, Sheila, sr1238@rwjms.rutgers.edu
- Recruiting
Lenox Hill Hospital Cystic Fibrosis Center
New York, New York, 10003
Teresa Demarco, Tdemarco3@northwell.edu
- Recruiting
Children's Hospital of New York
New York, New York, 10032
Hossein Sadeghi, HS762@cumc.Columbia.edu
- Recruiting
Oklahoma Cystic Fibrosis Center
Oklahoma City, Oklahoma, 73104
CF Center Participant Contact, cfresearchteam@ouhsc.edu
- Recruiting
CHOC Children's Hospital
Orange, California, 92868
Lila Klein, Lila.klein@choc.org
- Recruiting
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Ashley Scott, Ashley.Scott@osfhealthcare.org
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Melissa Molter, melissa.molter@pennmedicine.upenn.edu
- Recruiting
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Elizabeth Hartigan, elizabeth.hartigan@chp.edu
- Recruiting
Maine Medical Center
Portland, Maine, 04102
Harmony Renna, Harmony.Renna@mainehealth.org
- Recruiting
Oregon Health Sciences University
Portland, Oregon, 97239
Jenna Bucher, bucherj@ohsu.edu
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23219
Akilah Pierre-Louis, akilah.pierrelouis1@vcuhealth.org
- Recruiting
University of California at Davis Medical Center
Sacramento, California, 95817
Daniel Diaz-Vigil, ddiazvigil@ucdavis.edu
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Sharon McNamara, sharon.mcnamara@seattlechildrens.org
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Lauren Bartlett, lrejman@uw.edu
- Recruiting
Providence Medical Group, Cystic Fibrosis Clinic
Spokane, Washington, 99204
Joan Milton, joan.milton@providence.org
- Recruiting
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
Freda Branch, freda.branch@health.slu.edu
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Irma Bauer, irmabauer@wustl.edu
- Recruiting
All Children's Hospital
St. Petersburg, Florida, 33701
Diana Hodge, dhodge6@jhmi.edu
- Recruiting
Toledo Children's Hospital
Toledo, Ohio, 43606
Kelly Hoot, kelly.hoot@promedica.org
- Recruiting
Tucson Cystic Fibrosis Center
Tucson, Arizona, 85724
Elizabeth Ryan, elizabethryan@email.arizona.edu
- Recruiting
New York Medical College at Westchester Medical Center
Valhalla, New York, 10595
Zachary Messer, Zachary_Messer@nymc.edu
- Not yet recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Jack Serio, jserio@childrensnational.org
- Recruiting
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, 01655
Jaclyn Longtine, Jaclyn.Longtine@umassmed.edu
Canada1 site, 1 recruiting
- Recruiting
University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB)
Calgary, Alberta, T2N4N1
Clare Smith, Clare.smith@albertahealthservices.ca
About this study
Official title: Standardizing Treatments for Pulmonary Exacerbations: A Platform for Evaluating Treatment Decisions to Improve Outcomes (STOP360) Aminoglycoside Study (AG Study)
The purpose of this study is to look at pulmonary exacerbations in people with cystic fibrosis (CF) that need to be treated with antibiotics given through a tube inserted into a vein (intravenous or IV). A pulmonary exacerbation is a worsening of respiratory symptoms in people with CF that needs medical intervention. Both doctors and CF patients are trying to understand the best way to treat pulmonary exacerbations. This study is trying to answer the following questions about treating a pulmonary exacerbation:
- Do participants have the same improvement in lung function and symptoms if they are treated with one type of antibiotic (called beta-lactams or β-lactams) versus taking two different types of antibiotics (tobramycin and β-lactams)?
- Is taking one type of antibiotic just as good as taking two types?
Read the detailed description
Cystic Fibrosis Foundation (CFF) treatment guidelines for the management of pulmonary exacerbations (PEx) identified evidence gaps in current clinical best practices. The STOP program offers a platform for the conduct of controlled trials to develop the evidence base in order to define clinical best practices. The interventional Aminoglycoside Study (AG Study) will be a prospective, multi-center, parallel group, randomized (1:1 ratio), open-label, superiority study of intravenous aminoglycoside and β-lactams versus intravenous β-lactams only. Randomization will occur at Visit 1. The primary objective of this platform trial is to evaluate the efficacy and safety of differing treatments in CF PEx during a planned 14 day course of IV antimicrobials. Primary efficacy will be evaluated as the difference in mean Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) changes from Visit 1 to Visit 2 (Day 28 ± 2 days) between intervention arms.
- Being tested
- Beta-lactam antibiotic, Aminoglycoside
- Keywords
- Cystic Fibrosis, CF, Cystic Fibrosis Pulmonary Exacerbation, aminoglycoside, beta-lactam, β-lactam, STOP, STOP360
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-lactam antibioticDrug
Also called β-lactam
Intravenous (IV) β-lactam will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).
AminoglycosideDrug
Also called AG
Intravenous (IV) aminoglycoside will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).
| Study group | Role | What they receive |
|---|---|---|
| β-lactam Only (Non-AG) | Other | Participants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam as selected by their treating physician. Treatment must not include an IV aminoglycoside. Receives: Drug: Beta-lactam antibiotic |
| β-lactam and Aminoglycoside (AG) | Other | Participants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam and aminoglycoside selected by their treating physician. Receives: Drug: Beta-lactam antibiotic; Drug: Aminoglycoside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in FEV1 % Predicted at Week 4 in Aminoglycoside (AG) Study
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the absolute change in FEV1 % predicted from Week 0 (Day 0) to Week 4 (Day 28 ± 2 days)
Measured: Four weeks
Incidence of Adverse Events (AEs) in Aminoglycoside (AG) Study Intervention Arms
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the proportion of participants with at least one AE from Week 0 (Day 0) to Week 6 (Day 44 ± 2 days).
Measured: Six Weeks
Secondary outcomes (1)
Absolute Change in CFRSD-CRISS Score at Week 4 in Aminoglycoside (AG) Study
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the absolute change in respiratory symptoms, as measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) from Week 0 (Day 0) to Week 4 (Day 28 ± 2 days). The CFRSD-CRISS is derived from a set of questions asking a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start23 Apr 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The aminoglycoside study will compare treatment of an IV β-lactam and aminoglycoside (AG) versus an IV β-lactam only (non-AG). Individuals will be randomly assigned in a 1:1 fashion to receive either the AG or non-AG intervention for a planned 14 day course of IV antibiotics. IV antibiotic treatments for each intervention arm will be selected by the treating physician following standard of care.
- Masking
- None (open label)
- Enrolment
- 730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chris Goss
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Medical University of South Carolina, Cystic Fibrosis Foundation
- Responsible party
- Sponsor-investigator, Chris Goss, Seattle Children's Hospital
- Investigators
- Patrick Flume, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548283
- Sponsor's protocol ID
- STOP360-IP-22 AG
- Acronym
- STOP360AG
- Status last verified
- Jul 2026
- First submitted
- 16 Sep 2022
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardizing Treatments for Pulmonary Exacerbations: A Platform for Evaluating Treatment Decisions to Improve Outcomes (STOP360) Aminoglycoside Study (AG Study)
- ClinicalTrials.gov ID
- NCT05548283
- Acronym / sponsor ID
- STOP360AG / STOP360-IP-22 AG
- Keywords
- Cystic Fibrosis, CF, Cystic Fibrosis Pulmonary Exacerbation, aminoglycoside, beta-lactam, β-lactam, STOP, STOP360
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 730 participants (estimated)
- Lead sponsor
- Chris GossUniversity, hospital or other
- Collaborators
- University of Washington, Medical University of South Carolina, Cystic Fibrosis Foundation
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at pulmonary exacerbations in people with cystic fibrosis (CF) that need to be treated with antibiotics given through a tube inserted into a vein (intravenous or IV). A pulmonary exacerbation is a worsening of respiratory symptoms in people with CF that needs medical intervention. Both doctors and CF patients are trying to understand the best way to treat pulmonary exacerbations. This study is trying to answer the following questions about treating a pulmonary exacerbation:
- Do participants have the same improvement in lung function and symptoms if they are treated with one type of antibiotic (called beta-lactams or β-lactams) versus taking two different types of antibiotics (tobramycin and β-lactams)?
- Is taking one type of antibiotic just as good as taking two types?
Detailed description
Cystic Fibrosis Foundation (CFF) treatment guidelines for the management of pulmonary exacerbations (PEx) identified evidence gaps in current clinical best practices. The STOP program offers a platform for the conduct of controlled trials to develop the evidence base in order to define clinical best practices. The interventional Aminoglycoside Study (AG Study) will be a prospective, multi-center, parallel group, randomized (1:1 ratio), open-label, superiority study of intravenous aminoglycoside and β-lactams versus intravenous β-lactams only. Randomization will occur at Visit 1. The primary objective of this platform trial is to evaluate the efficacy and safety of differing treatments in CF PEx during a planned 14 day course of IV antimicrobials. Primary efficacy will be evaluated as the difference in mean Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) changes from Visit 1 to Visit 2 (Day 28 ± 2 days) between intervention arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The aminoglycoside study will compare treatment of an IV β-lactam and aminoglycoside (AG) versus an IV β-lactam only (non-AG). Individuals will be randomly assigned in a 1:1 fashion to receive either the AG or non-AG intervention for a planned 14 day course of IV antibiotics. IV antibiotic treatments for each intervention arm will be selected by the treating physician following standard of care.
| Arm | Type | Receives |
|---|---|---|
| β-lactam Only (Non-AG) | Other | Drug: Beta-lactam antibioticParticipants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam as selected by their treating physician. Treatment must not include an IV aminoglycoside. |
| β-lactam and Aminoglycoside (AG) | Other | Drug: Beta-lactam antibiotic, Drug: AminoglycosideParticipants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam and aminoglycoside selected by their treating physician. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-lactam antibioticAlso: β-lactamIntravenous (IV) β-lactam will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days). | Drug | β-lactam Only (Non-AG), β-lactam and Aminoglycoside (AG) |
| AminoglycosideAlso: AGIntravenous (IV) aminoglycoside will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days). | Drug | β-lactam and Aminoglycoside (AG) |
Primary outcome
Absolute Change in FEV1 % Predicted at Week 4 in Aminoglycoside (AG) Study
Time frame: Four weeks
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the absolute change in FEV1 % predicted from Week 0 (Day 0) to Week 4 (Day 28 ± 2 days)
Incidence of Adverse Events (AEs) in Aminoglycoside (AG) Study Intervention Arms
Time frame: Six Weeks
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the proportion of participants with at least one AE from Week 0 (Day 0) to Week 6 (Day 44 ± 2 days).
1 secondary outcome
Absolute Change in CFRSD-CRISS Score at Week 4 in Aminoglycoside (AG) Study
Time frame: Four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Flume, MD principal investigator
Medical University of South Carolina
60 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta-lactam antibiotic and Aminoglycoside in people with Cystic Fibrosis and Cystic Fibrosis Pulmonary Exacerbation, run by Chris Goss at 60 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 4 inclusion and 6 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rachael Buckingham, BS (206-884-7517, Rachael.buckingham@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change in FEV1 % Predicted at Week 4 in Aminoglycoside (AG) Study (time frame: Four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2026.