Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
NCT ID: NCT05548283
Last Updated: 2024-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
730 participants
INTERVENTIONAL
2023-04-23
2026-11-15
Brief Summary
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* 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?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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β-lactam Only (Non-AG)
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.
Beta-lactam antibiotic
Intravenous (IV) β-lactam will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).
β-lactam and Aminoglycoside (AG)
Participants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam and aminoglycoside selected by their treating physician.
Beta-lactam antibiotic
Intravenous (IV) β-lactam will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).
Aminoglycoside
Intravenous (IV) aminoglycoside will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).
Interventions
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Beta-lactam antibiotic
Intravenous (IV) β-lactam will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).
Aminoglycoside
Intravenous (IV) aminoglycoside will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
ALL
No
Sponsors
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University of Washington
OTHER
Medical University of South Carolina
OTHER
Cystic Fibrosis Foundation
OTHER
Chris Goss
OTHER
Responsible Party
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Chris Goss
Associate Director, UW Adult CF Center
Principal Investigators
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Patrick Flume, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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The Children's Hospital Alabama, University of Alabama at Birmingham
Birmingham, Alabama, United States
Tucson Cystic Fibrosis Center
Tucson, Arizona, United States
University of California San Diego
La Jolla, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
CHOC Children's Hospital
Orange, California, United States
University of California at Davis Medical Center
Sacramento, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Emory University
Atlanta, Georgia, United States
Saint Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
John Hopkins Hospital
Baltimore, Maryland, United States
Boston Children's Hospital, Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, United States
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Billings Clinic
Billings, Montana, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Morristown Medical Center
Morristown, New Jersey, United States
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Lenox Hill Hospital Cystic Fibrosis Center
New York, New York, United States
Children's Hospital of New York
New York, New York, United States
New York Medical College at Westchester Medical Center
Valhalla, New York, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
Toledo Children's Hospital
Toledo, Ohio, United States
Oklahoma Cystic Fibrosis Center
Oklahoma City, Oklahoma, United States
Oregon Health Sciences University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
University of Texas Southwestern / Children's Health
Dallas, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Providence Medical Group, Cystic Fibrosis Clinic
Spokane, Washington, United States
West Virginia University - Morgantown
Morgantown, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB)
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STOP360-IP-22 AG
Identifier Type: -
Identifier Source: org_study_id
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