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?
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Beta-lactam antibiotic
- Aminoglycoside
Treatment groups
Sponsors and collaborators
Chris Goss
Lead sponsor
Seattle Children's Hospital
Sponsor institution
University of Washington
Collaborator
Medical University of South Carolina
Collaborator
Cystic Fibrosis Foundation
Collaborator