Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
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|ClinicalTrials.gov Identifier: NCT02081963|
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : April 16, 2019
Last Update Posted : April 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-Cystic Fibrosis Bronchiectasis||Drug: Amikacin Drug: Normal saline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||178 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Nebulized amikacin
Participants receive nebulized amikacin BID for 14 days in combination with standard treatment.
Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.
Nebulized normal saline
Participants received nebulized normal saline BID for 14 days in combination with standard treatment.
Drug: Normal saline
Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.
- Bacterial Clearance Rate of Sputum [ Time Frame: after 14 days ]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.
- Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment [ Time Frame: after 14 days ]
- Sputum Property Score After 14 Days of Treatment [ Time Frame: after 14 days ]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.
- Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment [ Time Frame: after 14 days ]
- Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment [ Time Frame: after 14 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081963
|Qilu Hospital of Shandong University|
|Jinan, Shandong, China, 250012|
|Study Director:||Yu Li, Professor||Director|