At a glance
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Efficacy and Safety of tobRamycin Inhalation Solution for Pseudomonas AeruginoSa Eradication in Bronchiectasis (ERASE): a Multi-center, 2×2 Factorial Randomized, Double-blind, Placebo-controlled Trial
In Brief
A Phase 4 clinical trial evaluating Tobramycin Inhalant Product, Ciprofloxacin 750 MG, and 2 other interventions for Bronchiectasis Adult and Pseudomonas Aeruginosa Infection. Completed, enrolled 371 participants across 60 sites.
Detailed Summary
People with bronchiectasis are prone to Pseudomonas aeruginosa (PA) infections, which can become chronic and lead to increased death rates and disease severity. Studies from cystic fibrosis suggest that eradication therapy aimed at PA can successfully transition patients to a culture-negative status, providing long-term benefits. Current guidelines for managing bronchiectasis in adults recommend eradicating PA when it is first or newly isolated; however, there is a lack of randomized controlled trials supporting such recommendations. The researchers hypothesize that both oral ciprofloxacin combined with tobramycin inhalation solution and tobramycin inhalation solution alone are superior to no eradication (inhaled saline) in terms of the eradication rate of PA (with eradication defined as negative sputum culture results on two consecutive occasions separated by an interval of 12 weeks or more after the first drug administration).
Study Details
Timeline
Interventions
Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.
Oral ciprofloxacin 750mg twice daily will be prescribed for 2 weeks.
Oral ciprofloxacin placebo twice daily will be prescribed for 2 weeks.
Natural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.