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New treatment option for Cystic Fibrosis
Official title Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
ClinicalTrials.gov ID: NCT05548283
What this study is testing
What is Beta-lactam antibiotic?
Beta-lactam antibiotic is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cystic fibrosis.
Also referred to as β-lactam.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join 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 likely can't join 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- La Jolla, California, United States
- Long Beach, California, United States
- Orange, California, United States
- Sacramento, California, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Hollywood, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- St. Petersburg, Florida, United States
- Atlanta, Georgia, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- Peoria, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Louisville, Kentucky, United States
+ 33 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tucson, Arizona, United States; La Jolla, California, United States; Long Beach, California, United States; Orange, California, United States; Sacramento, California, United States and 47 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.