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NCT05548283 · ClinicalTrials.gov registry record · Phase 4
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study
A Phase 4 study of Cystic Fibrosis and Cystic Fibrosis Pulmonary Exacerbation, sponsored by Chris Goss.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 730
- Enrollment target
- 20
- Study locations
NCT05548283: Recruiting Phase 4 study of Cystic Fibrosis and Cystic Fibrosis Pulmonary Exacerbation, sponsored by Chris Goss.
NCT05548283 is a Phase 4 study of Cystic Fibrosis and Cystic Fibrosis Pulmonary Exacerbation that is actively recruiting participants, run by Chris Goss. The registered enrollment target is 730 participants, above the 175-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (317% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05548283, a Phase 4 study of Cystic Fibrosis and Cystic Fibrosis Pulmonary Exacerbation, is actively recruiting participants, sponsored by Chris Goss.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 730 participants
- Enrollment target
- 20
- Study locations
Study Summary
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?
Primary Outcome
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)
Conditions Studied
Interventions
- DRUG Beta-lactam antibiotic
- DRUG Aminoglycoside
Study Locations (20)
Florida
- University of Florida - Gainesville
- Joe DiMaggio Children's Hospital - Hollywood
- Nemours Children's Clinic - Jacksonville
- University of Miami - Miami
- All Children's Hospital - St. Petersburg
California
- University of California San Diego - La Jolla
- Long Beach Memorial Medical Center - Long Beach
- CHOC Children's Hospital - Orange
- University of California at Davis Medical Center - Sacramento
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
- Northwestern University - Chicago
- OSF Saint Francis Medical Center - Peoria
Indiana
- Indiana University Medical Center - Indianapolis
- Riley Hospital for Children - Indianapolis
Alabama
- The Children's Hospital Alabama, University of Alabama at Birmingham - Birmingham
Arizona
- Tucson Cystic Fibrosis Center - Tucson
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 730 participants |
| Start Date | 2023-04-23 |
| Est. Completion | 2026-11-15 |
| Phase | Phase 4 |
What NCT05548283 shows while recruiting
NCT05548283 is an interventional study that assigns participants to a tested intervention. The registered 730 participants enrollment target is mid-sized for trials with a published cap, above the 175-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (317% higher).
The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Beta-lactam antibiotic is the first listed.
NCT05548283 names 20 study sites across 10 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05548283 about?
NCT05548283 is a clinical study titled "Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside 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 med...
What is the current status of trial NCT05548283?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 730 participants. The study started on 2023-04-23. Estimated completion is 2026-11-15.
What conditions does trial NCT05548283 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation.
What interventions are being tested in trial NCT05548283?
The interventions under investigation include: Beta-lactam antibiotic (DRUG), Aminoglycoside (DRUG).
Who is sponsoring clinical trial NCT05548283?
This trial is sponsored by Chris Goss, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05548283 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05548283's enrollment target sits among peer trials
730 8th of 169 higher than 162 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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