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RECRUITINGPhase 4INTERVENTIONAL

Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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?

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

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).

DRUG

Aminoglycoside

Intravenous (IV) aminoglycoside will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).

Locations (20)

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