Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study

Recruiting now · Phase 4

Conditions studied: Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation

In brief

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?

Key facts

Study ID

NCT05548283

Run by

Chris Goss

People needed

730

Starts

2023-04-23

Expected to finish

2027-05-31

Last updated by the study team

2026-07-08

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Tucson Cystic Fibrosis Center — Tucson, Arizona, United States (enrolling)
• The Children's Hospital Alabama, University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Long Beach Memorial Medical Center — Long Beach, California, United States (enrolling)
• CHOC Children's Hospital — Orange, California, United States (enrolling)
• University of California at Davis Medical Center — Sacramento, California, United States (enrolling)
• University of California San Diego — La Jolla, California, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• Joe DiMaggio Children's Hospital — Hollywood, Florida, United States (enrolling)
• Nemours Children's Clinic — Jacksonville, Florida, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• All Children's Hospital — St. Petersburg, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Saint Luke's Cystic Fibrosis Center of Idaho — Boise, Idaho, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• OSF Saint Francis Medical Center — Peoria, Illinois, United States (enrolling)
• Indiana University Medical Center — Indianapolis, Indiana, United States (enrolling)
• Riley Hospital for Children — Indianapolis, Indiana, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• University of Louisville — Louisville, Kentucky, United States (enrolling)
• Maine Medical Center — Portland, Maine, United States (enrolling)
• John Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Boston Children's Hospital, Brigham & Women's Hospital — Boston, Massachusetts, United States (enrolling)
• University of Massachusetts Memorial Health Care — Worcester, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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