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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
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks
Awards & highlights

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had IV antibiotics, been in ICU, or had lung-related issues in the last 6 weeks.
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I haven't used experimental drugs or treatments for cystic fibrosis or NTM in the last 4 weeks.
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I have no kidney problems or history of organ transplants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and four weeks for reporting.

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

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Beta-lactams inhibit bacterial cell wall synthesis, preventing bacteria from maintaining their structural integrity, which is essential for their growth and survival. Tobramycin disrupts bacterial protein synthesis by binding to the bacterial ribosome, leading to cell death. These mechanisms are crucial for Cystic Fibrosis patients, who frequently suffer from chronic lung infections. Effective antibiotic treatments help manage these infections, reduce lung damage, and improve lung function and quality of life.
Drugs, Drugs, Drugs: Current Treatment Paradigms in Cystic Fibrosis Airway Infections.

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
University of WashingtonOTHER
1,762 Previous Clinical Trials
1,875,752 Total Patients Enrolled
24 Trials studying Cystic Fibrosis
45,137 Patients Enrolled for Cystic Fibrosis
Medical University of South CarolinaOTHER
947 Previous Clinical Trials
7,397,338 Total Patients Enrolled
3 Trials studying Cystic Fibrosis
1,204 Patients Enrolled for Cystic Fibrosis

Media Library

Aminoglycoside (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05548283 — Phase 4
Cystic Fibrosis Research Study Groups: β-lactam Only (Non-AG), β-lactam and Aminoglycoside (AG)
Cystic Fibrosis Clinical Trial 2023: Aminoglycoside Highlights & Side Effects. Trial Name: NCT05548283 — Phase 4
Aminoglycoside (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05548283 — Phase 4
Cystic Fibrosis Patient Testimony for trial: Trial Name: NCT05548283 — Phase 4
~469 spots leftby Nov 2026