What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Cystic Fibrosis, such as beta-lactams and tobramycin, have known side effects. Beta-lactams can cause allergic reactions, gastrointestinal issues like nausea and diarrhea, and occasionally hematologic effects such as neutropenia. Tobramycin is associated with nephrotoxicity (kidney damage) and ototoxicity (hearing loss), especially with long-term use. Monitoring for these side effects is crucial to ensure patient safety while managing CF.

What prior FDA approvals exist?

FDA-approved treatments for Cystic Fibrosis include beta-lactams such as piperacillin-tazobactam, cefepime, ceftazidime, and meropenem, which inhibit bacterial cell wall synthesis. Tobramycin, an aminoglycoside that disrupts bacterial protein synthesis, is also widely used. Inhaled aztreonam lysine is another FDA-approved alternative for patients who do not respond well to tobramycin. These drugs are often used in combination to manage chronic Pseudomonas aeruginosa infections in CF patients.

What other types of research exist?

Promising novel alternatives to traditional antibiotic regimens for CF patients include: 1) New formulations and delivery methods for existing antibiotics, such as different tobramycin formulations and nebulizers that reduce delivery time without compromising efficacy. 2) CFTR modulators, which have shown variable success in reducing the acquisition and prevalence of CF pathogens. 3) Aztreonam, which has shown advantages over tobramycin in some studies. Further clinical trials are needed to confirm the efficacy of these alternatives.

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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether using one antibiotic or two different antibiotics together is better for treating lung infections in people with cystic fibrosis. It targets patients with worsening lung symptoms needing IV antibiotics. The antibiotics work by killing or stopping bacteria to improve breathing and reduce symptoms.

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.

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.

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:

Select...

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.

Select...

I have no kidney problems or history of organ transplants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aminoglycosides

Incidence of Adverse Events (AEs) in Aminoglycoside (AG) Study Intervention Arms

Secondary study objectives

Absolute Change in CFRSD-CRISS Score at Week 4 in Aminoglycoside (AG) Study

Awards & Highlights

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.

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

Aminoglycoside

2022

N/A

~8000

Beta-lactam antibiotic

2008

Completed Phase 3

~370

0 / 3Eligibility criteria met

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.