Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

RecruitingPhase 4

Standardizing Treatments for Pulmonary Exacerbations: A Platform for Evaluating Treatment Decisions to Improve Outcomes (STOP360) Aminoglycoside Study (AG Study)

Who can join

Ages 6 and older · All sexes

Full eligibility criteria

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

About the 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?

What is being tested

Beta-lactam antibiotic (drug)
Aminoglycoside (drug)

Sponsor: Chris Goss · Participants: 730 · Started: Apr 23, 2023

Contact the study team

Rachael Buckingham, BS · Phone: 206-884-7517
Barbra Fogarty · Phone: 206-884-7592

Official record on ClinicalTrials.gov — NCT05548283

Locations in the U.S.

Alabama	The Children's Hospital Alabama, University of Alabama at Birmingham, Birmingham
Arizona	Tucson Cystic Fibrosis Center, Tucson
California	University of California San Diego, La Jolla Long Beach Memorial Medical Center, Long Beach CHOC Children's Hospital, Orange University of California at Davis Medical Center, Sacramento
District of Columbia	Children's National Medical Center, Washington D.C. (Not yet recruiting)
Florida	University of Florida, Gainesville Joe DiMaggio Children's Hospital, Hollywood Nemours Children's Clinic, Jacksonville University of Miami, Miami All Children's Hospital, St. Petersburg
Georgia	Emory University, Atlanta
Idaho	Saint Luke's Cystic Fibrosis Center of Idaho, Boise
Illinois	Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago Northwestern University, Chicago OSF Saint Francis Medical Center, Peoria
Indiana	Indiana University Medical Center, Indianapolis Riley Hospital for Children, Indianapolis
Iowa	University of Iowa, Iowa City
Kansas	University of Kansas Medical Center, Kansas City
Kentucky	University of Louisville, Louisville
Maine	Maine Medical Center, Portland
Maryland	John Hopkins Hospital, Baltimore
Massachusetts	Boston Children's Hospital, Brigham & Women's Hospital, Boston University of Massachusetts Memorial Health Care, Worcester
Michigan	University of Michigan, Michigan Medicine, Ann Arbor Helen DeVos Children's Hospital, Grand Rapids
Missouri	SSM Health Cardinal Glennon Children's Hospital, St Louis Washington University School of Medicine, St Louis
Montana	Billings Clinic, Billings
New Hampshire	Dartmouth Hitchcock Medical Center, Lebanon
New Jersey	Morristown Medical Center, Morristown Rutgers - Robert Wood Johnson Medical School, New Brunswick
New York	Children's Hospital of New York, New York Lenox Hill Hospital Cystic Fibrosis Center, New York New York Medical College at Westchester Medical Center, Valhalla
Ohio	Children's Hospital Medical Center of Akron, Akron Cincinnati Children's Hospital Medical Center, Cincinnati University of Cincinnati Medical Center, Cincinnati Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland Nationwide Children's Hospital, Columbus Dayton Children's Hospital, Dayton Toledo Children's Hospital, Toledo
Oklahoma	Oklahoma Cystic Fibrosis Center, Oklahoma City
Oregon	Oregon Health Sciences University, Portland
Pennsylvania	University of Pennsylvania, Philadelphia Children's Hospital of Pittsburgh of UPMC, Pittsburgh
South Carolina	Medical University of South Carolina, Charleston
Tennessee	Vanderbilt Children's Hospital, Nashville
Texas	University of Texas Southwestern, Dallas University of Texas Southwestern / Children's Health, Dallas Cook Children's Medical Center, Fort Worth
Virginia	Virginia Commonwealth University, Richmond
Washington	Seattle Children's Hospital, Seattle University of Washington Medical Center, Seattle Providence Medical Group, Cystic Fibrosis Clinic, Spokane
West Virginia	West Virginia University - Morgantown, Morgantown
Wisconsin	University of Wisconsin, Madison

Conditions

Cystic Fibrosis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.