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Bronchoscopic Levofloxacin, Gentamicin, or Sham for Acute Exacerbation of Bronchiectasis
Sponsor: Assiut University
Summary
Randomized single-center trial evaluating whether bronchoscopic instillation of levofloxacin or gentamicin improves outcomes compared to a sham bronchoscopic procedure in adult ICU patients with non-cystic fibrosis bronchiectasis requiring invasive mechanical ventilation. The primary outcome is a ranked composite of in-hospital mortality and time to ventilator liberation. Safety and procedural adverse events are closely monitored.
Official title: A Randomized Sham-Controlled Trial of Bronchoscopic Levofloxacin and Gentamicin Versus Sham in Mechanically Ventilated Bronchiectasis: Acute and 1-Year Outcomes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
315
Start Date
2023-10-15
Completion Date
2027-02-01
Last Updated
2025-07-17
Healthy Volunteers
No
Conditions
Interventions
Local instillation of gentamicin and Budesonide
Bronchoscopic local instillation of gentamicin and Budesonide
Local instillation of Levofloxacin and Budesonide
Bronchoscopic local instillation of Levofloxacin and Budesonide
Bronchoscopic mechanical secretion suction and lavage
Bronchoscopic mechanical secretion suction and lavage
Sham Bronchoscopy
Bronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure).
Locations (1)
Assiut university hospitals
Asyut, Egypt