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Recruiting Phase 4

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

NCT06209047 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 4
Started
2023-10-15
Last updated
2025-07-17

Condition(s) studied

Bronchiectasis With Acute Exacerbation

Investigational drug(s) / intervention(s)

Local instillation of gentamicin and BudesonideLocal instillation of Levofloxacin and BudesonideBronchoscopic mechanical secretion suction and lavageSham Bronchoscopy

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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Days for weaning from mechanical ventilation — one month
    days of mechanical ventilation will be measured and compared between drug and conventional groups

Trial sites (1)

FacilityCityRegionStatus
Assiut university hospitals Asyut Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06209047 on ClinicalTrials.gov ↗ ← All trials in Egypt