Compares two antibiotic treatments for lung flare-ups in cystic fibrosis
Compares one antibiotic type with two types for cystic fibrosis lung flare-ups.
Plain-language title generated from the registry record
Registry title: Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
Key facts
- Where
- Calgary, CanadaSee the site
- Phase
- Phase 4
Where in Canada
- University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB)Calgary, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chris Goss
- Trial code
- NCT05548283
- Record updated
- 8 July 2026
- Original description
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:Read full original descriptionShow less
Standardizing Treatments for Pulmonary Exacerbations: A Platform for Evaluating Treatment Decisions to Improve Outcomes (STOP360) Aminoglycoside Study (AG 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?
Inclusion: 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: 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 more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1; No known renal impairment or history of solid organ transplantation; No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides; Participant is not pregnant.