Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis

Conditions
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Non-Cystic Fibrosis Bronchiectasis

Intervention / Treatment
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* Drug: Amikacin
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female study subjects ≥18 years of age and ≤80 years of age; Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis; Confirmation of infection with Pseudomonas aeruginosa at screening; Are sensitive to amikacin; Acute exacerbation of bronchiectasis. Exclusion Criteria: Bronchiectasis due to special causes; Smokers; Are associated with bronchial asthma; Have any serious or active medical or psychiatric illness; Be allergic to amikacin or not tolerant to nebulised amikacin(FEV1 reduces ≥15% after inhaling amikacin.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulized amikacin<br>Participants receive nebulized amikacin BID for 14 days in combination with standard treatment. | Drug: Amikacin<br>* Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.<br>|
| Other: Nebulized normal saline<br>Participants received nebulized normal saline BID for 14 days in combination with standard treatment. | Drug: Normal saline<br>* Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial Clearance Rate of Sputum | The bacterial eradication rate of the sputum was calculated by the number of P. aeruginosa-eradicated cases according to sputum culture testing result. Sputum samples were collected in the morning after toothbrushing and gargling, before the patients used any medicine. Eligible sputum samples were defined as having ≥25 white blood cells/highpower field and ≤10 epithelial cells/high-power field; the samples were sent for testing within 60 min. Sputum samples were collected again after 14 days. If the second sputum culture test showed a negative result after the first one had been positive, it was defined as eradicated. | after 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment |  | after 14 days | 
| Sputum Property Score After 14 Days of Treatment | The sputum properties were graded from 1 to 4, with 1 being assigned to transparent mucous sputum, 2 to yellow purulent sputum, 3 to green purulent sputum, and 4 to black green purulent sputum. Higher scores mean a worse outcome. | after 14 days | 
| Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment |  | after 14 days | 
| Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment |  | after 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nebulized amikacin;, Non-Cystic Fibrosis Bronchiectasis;, Bacterial clearance rate of sputum；, Acute exacerbation.