Conditions: Non-Cystic Fibrosis Bronchiectasis
Keywords: Nebulized amikacin; Non-Cystic Fibrosis Bronchiectasis; Bacterial clearance rate of sputum； Acute exacerbation.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 178
Healthy volunteers: no

Brief summary:
This is a multi-centered, randomized, controlled study to assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance.

Detailed description:
Objective: To assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance.

Methods: Patients with acute exacerbation of non-cystic fibrosis bronchiectasis will be randomly assigned to the observer group (participants receive nebulized amikacin BID for 14 days in combination with standard treatment) or the control group (participants receive nebulized 0.9% saline BID for 14 days in combination with standard treatment). The primary endpoint was bacterial clearance rate of sputum.

Expected results: Compared with the control group, bacterial clearance rate of sputum of the observer Group will increase significantly.

Arms:
arm 1: Participants receive nebulized amikacin BID for 14 days in combination with standard treatment. arm 2: Participants received nebulized normal saline BID for 14 days in combination with standard treatment.

Interventions: intervention 1: Amikacin intervention 2: Normal saline
Intervention descriptions: intervention 1: Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment. intervention 2: Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.

Protocol document: