Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

What this study is about

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 can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• 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

+ 48 more sites.

Who to contact

Rachael Buckingham, BS · 206-884-7517 · Rachael.buckingham@seattlechildrens.org

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05548283.