Cystic Fibrosis study: Beta-lactam antibiotic vs Aminoglycoside
Official title Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
ClinicalTrials.gov ID: NCT05548283
What this study is testing
What is Beta-lactam antibiotic?
An investigational intravenous antibiotic being studied as a potential treatment for pulmonary exacerbations in cystic fibrosis. It is designed to kill bacteria by inhibiting bacterial cell wall synthesis.
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
- This study is looking at whether one antibiotic works as well as two for treating cystic fibrosis lung flare‑ups.
- Who it's for
- You may be able to join if you have cystic fibrosis and are having a lung flare that needs IV antibiotics.
- What's involved
- You will receive IV antibiotics in the hospital. You might get either one drug (a beta‑lactam) or two drugs (a beta‑lactam plus tobramycin). You will have lung tests and symptom checks during treatment.
- Time commitment
- The study lasts for the length of your IV antibiotic course, with a few hospital visits for tests.
- 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 is enrolling
- 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
- 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
- Portland, Maine, United States
+ 32 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at 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 46 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.