Instillation of Gentamicin and Dexamethasone in Bronchiectasis Compared to Conventional Treatment

Assiut University

Status and phase: Enrolling; Phase 4

Conditions: Bronchiectasis With Acute Exacerbation

Treatments: Drug: bronchoscopic airway clearance followed by local instillation of gentamicin and dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT06209047

gentamicin in bronchiectasis

Details and patient eligibility

About

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

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 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.

Enrollment: 70 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

drug group

Experimental group

Description:

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.

Treatment:

Drug: bronchoscopic airway clearance followed by local instillation of gentamicin and dexamethasone

control group

No Intervention group

Description:

his arm will include the other half number of cases(35 cases) selected in a randomized manner and will receive only conventional treatment without intervention.