NCT05548283 · Chris Goss
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
(STOP360AG)
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 (given through a vein (IV) or IV). A pulmonary exacerbation is a worsening of respiratory symptoms in people with CF that needs medical intervention.
View original scientific 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.
Interventions
DRUG
Beta-lactam antibiotic
Intravenous (IV) β-lactam will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).
DRUG
Aminoglycoside
Intravenous (IV) aminoglycoside will be selected by the treating physician following standard of care. Treatment will last for 14 days (± 2 days).
Primary outcome measures
Absolute Change in FEV1 % Predicted at Week 4 in Aminoglycoside (AG) Study
Time frame: Four weeks
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the absolute change in FEV1 % predicted from Week 0 (Day 0) to Week 4 (Day 28 ± 2 days)
Incidence of Adverse Events (AEs) in Aminoglycoside (AG) Study Intervention Arms
Time frame: Six Weeks
Difference between aminoglycoside (AG) study intervention arms (AG - Non-AG) in the proportion of participants with at least one AE from Week 0 (Day 0) to Week 6 (Day 44 ± 2 days).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- Birmingham, Alabama
- Tucson, Arizona
- La Jolla, California
- Long Beach, California
- Orange, California
- Sacramento, California
- Washington D.C., District of Columbia
- Gainesville, Florida
- Hollywood, Florida
- Jacksonville, Florida
- Miami, Florida
- St. Petersburg, Florida
And 40 more locations — see the full list below.
Collaborators
University of Washington, Medical University of South Carolina, Cystic Fibrosis Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations