Clinical trial

A Study of the Clinical Benefit of Tobramycin Inhalation Solution

Name

LCYX-YR-20230101

Description

This project will use literature analysis, expert research, real-world data mining and other methods to investigate the current status of the application of antimicrobial aerosolized inhalation in healthcare institutions, combine expert recommendations and real-world data analysis results to explore potential risk points in the process of antimicrobial aerosolized drug delivery, and sort out the key points of drug use management in healthcare institutions and the key points of regulatory recommendations for healthcare institutions.

Trial arms

Trial start

2021-01-01

Estimated PCD

2024-01-31

Trial end

2024-04-30

Status

Active (not recruiting)

Treatment

Tobramycin inhalation solution

Tobramycin Inhalation Solution is a yellowish clear liquid, the main ingredient is tobramycin. Antimicrobial non-nebulized inhalation preparation according to the current clinical situation, mainly polymyxin, amikacin, depending on the specific circumstances of each hospital.

Arms:

Bronchiectasis, Cystic fibrosis, Multidrug-resistant bacterial lung infections

Other names:

Antimicrobial non-nebulized inhalation preparations

Size

1600

Primary endpoint

Total Adverse Reaction Incidence Rate

Through study completion，up to half a year.

Pathogen clearance

Through study completion，up to half a year.

Average hospitalization cost per visit

Through study completion，up to half a year.

Eligibility criteria

Inclusion Criteria: * Bronchiectasis 1. Patients with a past medical history or a diagnosis of bronchiectasis in the current case; 2. Patients seen or admitted to the hospital from 1 January 2021 to 31 December 2023 (including outpatient, emergency, and inpatient); 3. Case record of at least 1 course of treatment (continuous administration for 28 days) with tobramycin inhalation solution or other antibiotic nebulisation; 4. Patients with a positive copper-green test at the first visit. * Cystic fibrosis 1. Patients with a past medical history or a diagnosis of cystic fibrosis in the current case; 2. Patients who were seen or admitted to the hospital from 1 January 2021 to 31 December 2023 (including outpatient, emergency, and inpatient); 3. Case record of at least 1 course of treatment (continuous administration for 28 days) with tobramycin inhalation solution or other antibiotic nebulisation; 4. Patients with a positive copper-green test at the first visit. * Multidrug-resistant bacterial lung infections 1. Patients with a diagnosis of pulmonary infection; 2. Patients admitted to the hospital from 1 January 2021 to 31 December 2023 (only inpatients were included); 3. Case records with completion of at least 3 days of treatment with tobramycin inhalation solution or other antibiotic nebulisation; 4. The patient tested positive for pathogens at least once during the period of medication. Exclusion Criteria: * Bronchiectasis Patients with key information missing from the study, such as therapeutic agents, diagnostic information for bronchiectasis, etc. * Cystic fibrosis Patients with cystic fibrosis, for which key information is missing, such as treatment medication, diagnosis of cystic fibrosis. * Multidrug-resistant bacterial lung infections Patients hospitalized with severe pneumonia were missing key study information, such as laboratory tests not performed.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 1600, 'type': 'ESTIMATED'}}

Updated at

2023-10-30

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication