RECRUITINGPhase 4INTERVENTIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - patients with bronchiectasis confirmed by high-resolution CT chest(HRCT) - patients with acute exacerbation of bronchiectasis who need antibiotic treatment at the hospital due to exacerbation - mechanically ventilated patients in the respiratory ICU - Age more than or equal to 18 years Who Should NOT Join This Trial: - patients with active pulmonary tuberculosis - patients with allergic bronchopulmonary aspergillosis - patients who underwent interventional bronchoscopy for hemoptysis - age less than 18 years Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * patients with bronchiectasis confirmed by high-resolution CT chest(HRCT) * patients with acute exacerbation of bronchiectasis who need antibiotic treatment at the hospital due to exacerbation * mechanically ventilated patients in the respiratory ICU * Age more than or equal to 18 years Exclusion Criteria: * patients with active pulmonary tuberculosis * patients with allergic bronchopulmonary aspergillosis * patients who underwent interventional bronchoscopy for hemoptysis * age less than 18 years

Treatments Being Tested

DRUG

Local instillation of gentamicin and Budesonide

Bronchoscopic local instillation of gentamicin and Budesonide

DRUG

Local instillation of Levofloxacin and Budesonide

Bronchoscopic local instillation of Levofloxacin and Budesonide

PROCEDURE

Bronchoscopic mechanical secretion suction and lavage

PROCEDURE

Sham Bronchoscopy

Bronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure).

Locations (1)

Assiut university hospitals

Asyut, Egypt