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

ConditionBronchiectasis With Acute Exacerbation

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorAssiut University

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

patients with active pulmonary tuberculosis

patients with allergic bronchopulmonary aspergillosis

patients who underwent interventional bronchoscopy for hemoptysis

age less than 18 years

Trial design

Treatments tested in this trial

Local instillation of gentamicin and Budesonide
Local instillation of Levofloxacin and Budesonide
Bronchoscopic mechanical secretion suction and lavage
Sham Bronchoscopy

Treatment groups

315 Participants

are divided into 3 treatment groups

Sponsors and collaborators

Assiut University

Lead sponsor

Source ClinicalTrials.gov