Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
Eligible age
6+ yrs
Accepts
All genders
Locations
32 states
Healthy volunteers
No
See if you qualify for this study
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About this 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?
Sponsor: Chris Goss
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's recruiting
Source: ClinicalTrials.gov · NCT05548283 · last updated 2024-08-26