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A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
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.
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Qilu Hospital of Shandong University
Jinan, Shandong, China
Start Date
March 1, 2014
Primary Completion Date
March 1, 2016
Completion Date
December 1, 2016
Last Updated
April 24, 2019
178
ACTUAL participants
Amikacin
DRUG
Normal saline
DRUG
Lead Sponsor
Qilu Hospital of Shandong University
NCT07289464
NCT04594369
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04656275