NCT06106789

A Study of the Clinical Benefit of Tobramycin Inhalation Solution

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,600 (estimated)
• Sponsor: Qianfoshan Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-04-30
• Completion: 2024-10-30
• First posted: 2023-10-30
• Last updated: 2024-10-17

Locations

1 site across 1 country: China