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Antibiotic
Antibiotics for Cystic Fibrosis Pulmonary Exacerbations (STOP360AG Trial)
Phase 4
Recruiting
Led By Patrick Flume, MD
Research Sponsored by Chris Goss
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks
Awards & highlights
STOP360AG Trial Summary
This trial is studying if one type of antibiotic is as effective as two types in treating pulmonary exacerbations in people with cystic fibrosis.
Who is the study for?
This trial is for people with cystic fibrosis aged 6 and above who've had a specific lung infection. They must be planning to start a 14-day IV antibiotic treatment for worsening respiratory symptoms. Those pregnant, with kidney issues, organ transplants, or bad reactions to certain antibiotics can't join.Check my eligibility
What is being tested?
The study compares the effectiveness of two antibiotic treatments for cystic fibrosis-related lung problems: one using only beta-lactam antibiotics versus another combining beta-lactams with an aminoglycoside called tobramycin.See study design
What are the potential side effects?
Possible side effects include allergic reactions, kidney damage (especially from aminoglycosides), hearing loss or balance issues (from toxicity related to aminoglycosides), and general antibiotic side effects like stomach upset.
STOP360AG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ four weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aminoglycosides
Incidence of Adverse Events (AEs) in Aminoglycoside (AG) Study Intervention Arms
Secondary outcome measures
Absolute Change in CFRSD-CRISS Score at Week 4 in Aminoglycoside (AG) Study
STOP360AG Trial Design
2Treatment groups
Experimental Treatment
Group I: β-lactam and Aminoglycoside (AG)Experimental Treatment2 Interventions
Participants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam and aminoglycoside selected by their treating physician.
Group II: β-lactam Only (Non-AG)Experimental Treatment1 Intervention
Participants randomized to this arm will be prescribed a standard of care intravenous (IV) β-lactam as selected by their treating physician. Treatment must not include an IV aminoglycoside.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Beta-lactam antibiotic
2008
Completed Phase 3
~370
Aminoglycoside
2022
N/A
~8000
Find a Location
Who is running the clinical trial?
Chris GossLead Sponsor
4 Previous Clinical Trials
1,540 Total Patients Enrolled
4 Trials studying Cystic Fibrosis
1,540 Patients Enrolled for Cystic Fibrosis
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1,741 Previous Clinical Trials
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45,137 Patients Enrolled for Cystic Fibrosis
Medical University of South CarolinaOTHER
933 Previous Clinical Trials
7,393,906 Total Patients Enrolled
3 Trials studying Cystic Fibrosis
1,204 Patients Enrolled for Cystic Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used experimental drugs or treatments for cystic fibrosis or NTM in the last 4 weeks.I haven't had IV antibiotics, been in ICU, or had lung-related issues in the last 6 weeks.You have had a positive culture for a specific bacteria called Pseudomonas aeruginosa within the two years before your first study visit.I have received IV aminoglycosides for one day or less for my current treatment.I have no kidney problems or history of organ transplants.You haven't had bad reactions to aminoglycoside antibiotics that affect your hearing or balance.My doctor plans to treat my cystic fibrosis exacerbation with a 14-day course of IV antibiotics.I am 6 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: β-lactam Only (Non-AG)
- Group 2: β-lactam and Aminoglycoside (AG)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cystic Fibrosis Patient Testimony for trial: Trial Name: NCT05548283 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA recognize this method as a viable therapeutic strategy?
"This treatment has been approved, and as such earned a security score of 3. As this is a phase 4 trial, the safety of the intervention has been well established."
Answered by AI
What is the range of facilities that are overseeing this trial?
"This clinical trial is being operated at numerous medical centres, such as Nationwide Children's Hospital in Columbus, University of Cincinnati Medical Center in Cincinnati and Emory University in Atlanta. There are a total of 57 sites scattered across the country."
Answered by AI
Is there still capacity for new participants in this research project?
"Affirmative, according to the information on clinicaltrials.gov this experiment is actively recruiting participants since April 23rd of 2023. Recent changes were made on May 16th of 2023 and currently over 700 individuals are needed across 57 trial sites."
Answered by AI
How many volunteers are currently involved in this research program?
"This trial necessitates the enrolment of 730 participants with qualifying inclusion criteria. Those interested can join this research at various locations, such as Nationwide Children's Hospital in Columbus, Ohio and University of Cincinnati Medical Center in Cincinnati, Georgia."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
University of Miami
All Children's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I've had a friend with CF. I'm healthy and would like to be apart of something thar can potentially help others.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long is the trial and is there any stay overs?
PatientReceived no prior treatments
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