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

Assiut University

Status and phase: Enrolling; Phase 4

Conditions: Bronchiectasis With Acute Exacerbation

Treatments: Procedure: Sham Bronchoscopy; Procedure: Bronchoscopic mechanical secretion suction and lavage; Drug: Local instillation of gentamicin and Budesonide; Drug: Local instillation of Levofloxacin and Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT06209047

AU-12578383

Details and patient eligibility

About

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.

Full description

Bronchiectasis is a chronic suppurative and inflammatory lung disease of diverse etiology characterized by pathological and irreversible dilatation of the bronchial tree. The impairment of the mucociliary clearance, which results from chronic airway inflammation, may cause long-term colonization or recurrent infection of bacteria, especially Pseudomonas aeruginosa (PA), while bacterial colonization and recurrent infection can aggravate airway inflammation. Sputum retention caused by the impairment of mucociliary clearance can result in mucous plugs, which in turn contribute to airflow obstruction and dyspnea.

Clinically, the major manifestations of bronchiectasis include chronic cough with purulent sputum, dyspnea, and fatigue, which can significantly diminish patients' quality of life. The frequency of exacerbations and decline in lung function may lead to a poor prognosis and a decrease in quality of life.

The purpose of bronchiectasis management is to reduce exacerbations, prevent complications, and improve the quality of life. Long-term instillation of antibiotics and steroids can reduce the concentration of bacteria in the airways, decrease sputum production, attenuate lung function decline, and reduce acute pulmonary exacerbations without nephrotoxicity or ototoxicity. Dexamethasone is one of the most common glucocorticoids that can inhibit the expression levels of inflammatory factors in the airway and reduce the secretion of airway mucus. Topical administration could also reduce the systemic side effects.

Enrollment: 315 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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315 participants in 3 patient groups

Gentamicin group

Experimental group

Description:

This arm will undergo bronchoscopic airway clearance followed by local instillation of gentamicin (80 mg once) and Budesonide (0.5 mg) once.

Treatment:

Drug: Local instillation of gentamicin and Budesonide

Procedure: Bronchoscopic mechanical secretion suction and lavage

Levofloxacin group

Experimental group

Description:

This arm will undergo bronchoscopic airway clearance followed by bronchoscopic instillation of levofloxacin 480 mg in isotonic saline during standardized bronchoscopy. And Budesonide (0.5 mg) once.

Treatment:

Drug: Local instillation of Levofloxacin and Budesonide

Procedure: Bronchoscopic mechanical secretion suction and lavage

Sham group

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham Bronchoscopy