Instillation of Gentamicin and Dexamethasone in Bronchiectasis Compared to Conventional Treatment

Phase 4

Recruiting

• Conditions: Bronchiectasis With Acute Exacerbation
• Interventions: Drug: bronchoscopic airway clearance followed by local instillation of gentamicin and dexamethasone

• Registration Number: NCT06209047
• Lead Sponsor: Assiut University

Brief Summary

Safety and efficacy of local instillation of Gentamicin and dexamethasone in acute exacerbation of bronchiectasis in mechanically ventilated patients

Detailed 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 are chronic cough with purulent sputum, dyspnea, and fatigue that may diminish the patients' quality of life. The frequency of exacerbation and the decline in lung function may lead to poor prognosis and decrease quality of life.

The purpose of bronchiectasis management is to reduce exacerbation, prevent complications, and improve the quality of life. Long-term instillation of gentamicin 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 which 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.

Study Timeline

• Study First Submitted: 2023-12-26
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-13
• Study First Posted: 2024-01-17
• Study Start: 2024-01-25
• Last Update Submitted: 2024-08-03
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• patients with bronchiectasis confirmed by high resolution CT chest(HRCT)
• patients with acute exacerbation of bronchiectasis who need antibiotic treatment at hospital due to exacerbation
• mechanically ventillated patients at respiratory ICU
• Age more than or equal 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug group	bronchoscopic airway clearance followed by local instillation of gentamicin and dexamethasone	this arm will include half number of cases(which will be 35 cases) selected in a randomized manner and will undergo bronchoscopic airway clearance followed by local instillation of gentamicin(80 mg once) and dexamethasone(5 mg) once.

Primary Outcome Measures

Name	Time	Method
The amount of sputum production per day(ml/day)	one year	the total amount of sputum per day will be measured and compared between drug and conventional groups
Days for weaning from mechanical ventilation	one year	days of mechanical ventilation will be measured and compared between drug and conventional groups

Secondary Outcome Measures

Name	Time	Method
Days of intensive care unit(ICU) and hospital stay	one year	days of ICU and hospital stay will be measured
days for recurrence	one year	days for recurrence or next exacerbation will be measured

Trial Locations

Locations (1)

Assiut university hospitals; 🇪🇬 Assiut, Egypt