RecruitingPhase 4NCT06209047

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


Sponsor

Assiut University

Enrollment

315 participants

Start Date

Oct 15, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • patients with active pulmonary tuberculosis
  • patients with allergic bronchopulmonary aspergillosis
  • patients who underwent interventional bronchoscopy for hemoptysis
  • age less than 18 years

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Interventions

DRUGLocal instillation of gentamicin and Budesonide

Bronchoscopic local instillation of gentamicin and Budesonide

DRUGLocal instillation of Levofloxacin and Budesonide

Bronchoscopic local instillation of Levofloxacin and Budesonide

PROCEDUREBronchoscopic mechanical secretion suction and lavage

Bronchoscopic mechanical secretion suction and lavage

PROCEDURESham Bronchoscopy

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


Locations(1)

Assiut university hospitals

Asyut, Egypt

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NCT06209047


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