A Study of the Clinical Benefit of Tobramycin Inhalation Solution

NCT ID: NCT06106789

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-10-30

Brief Summary

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.

Detailed Description

The current status of nebulised inhalation of antimicrobial drugs was examined by the main subject through literature search and expert research. The researchers selected patients who visited or were admitted to Qianfoshan Hospital in Shandong Province during the period from 1 January 2021 to 31 December 2023, extracted data according to the inclusion and exclusion criteria, and used tobramycin inhalation solution as the study group, and injectable antimicrobials used by inhalation such as amikacin, polymyxin E sodium methanesulfonate, polymyxin E sulphate, polymyxin B sulphate and other antimicrobials in a multicentre real-world cohort study as the control group, and adopted a multi A multi-centre real-world cohort study was conducted to examine the effectiveness, safety and economy of nebulised inhalation of antimicrobial drugs in different levels of healthcare institutions in China, to directly compare the risk of use of injectable over-the-counter nebulised inhalation with that of inhalation formulations, and also to provide post-marketing re-evaluation for the newly marketed tobramycin inhalation solution and to provide evidence-based evidence for the rational use of medication in the clinic.

Conditions

Bronchiectasis; Cystic Fibrosis; Lung Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Tobramycin inhalation solution

Intervention Type: DRUG

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.

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.

Tobramycin inhalation solution

Intervention Type: DRUG

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.

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.

Tobramycin inhalation solution

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Antimicrobial non-nebulized inhalation preparations

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rui Yang

Associate professor of pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rui Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Qianfoshan Hospital

Locations

Rui Yang,MD

Jinan, Shandong, China

Countries

China

Other Identifiers

LCYX-YR-20230101

Identifier Type: -

Identifier Source: org_study_id