A Randomized Sham-Controlled Trial of Bronchoscopic Levofloxacin and Gentamicin Versus Sham in Mechanically Ventilated Bronchiectasis: Acute and 1-Year Outcomes

What this Trial Is About

This trial investigates whether bronchoscopic instillation of the antibiotics levofloxacin or gentamicin improves outcomes compared to a sham procedure in adults with bronchiectasis experiencing an acute exacerbation who require invasive mechanical ventilation in the intensive care unit. Bronchiectasis is a chronic lung condition causing airway damage, mucus buildup, infection, and inflammation, which can worsen symptoms like cough and breathlessness and reduce quality of life. This study aims to reduce complications and improve recovery by applying treatments directly to the airways. Participants are randomly assigned to one of three groups. One group receives bronchoscopic airway clearance followed by local instillation of gentamicin and budesonide, another receives bronchoscopic airway clearance followed by instillation of levofloxacin and budesonide, and the third group undergoes a sham bronchoscopy without drug instillation. Budesonide is included to help reduce airway inflammation. The study carefully monitors safety and procedure-related side effects. During the study, patients are evaluated for time to weaning off mechanical ventilation as the primary outcome within one month. Secondary outcomes measured over one year include daily sputum production, walking distance, number of exacerbations, hospital admissions, quality of life, and assessments of anxiety and depression. The study involves bronchoscopic procedures, lung imaging, and clinical monitoring to track participants' progress and safety throughout the follow-up period.

Bronchoscopic Levofloxacin, Gentamicin, or Sham for Acute Exacerbation of Bronchiectasis