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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchiectasis |
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| Cystic fibrosis |
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| Multidrug-resistant bacterial lung infections |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobramycin inhalation solution | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Adverse Reaction Incidence Rate | To evaluate the safety of injectable over-the-counter nebulized inhalation versus inhalation formulations by analyzing the incidence of total adverse reactions, and to provide first-line, real-world data to support post-market re-evaluation. | Through study completion,up to half a year. |
| Pathogen clearance | To evaluate the effectiveness of the clinical application of injectable over-the-counter nebulized inhalation versus inhalation formulations by analyzing the pathogen clearance rate, and to provide first-line real-world data support for post-market re-evaluation of the product. | Through study completion,up to half a year. |
| Average hospitalization cost per visit | To provide first-line, real-world data support for post-market re-evaluation of the product by analyzing the average per-hospitalization cost to evaluate the economics of the clinical application of injectable over-the-counter nebulized inhalation versus inhalation formulations. | Through study completion,up to half a year. |
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Inclusion Criteria:
Bronchiectasis
Cystic fibrosis
Multidrug-resistant bacterial lung infections
Exclusion Criteria:
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Patients seen or admitted to the hospital (including outpatient, emergency, and inpatient) from January 1, 2021 - December 31, 2023, including:
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| Name | Affiliation | Role |
|---|---|---|
| Rui Yang, MD | Qianfoshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rui Yang,MD | Jinan | Shandong | China |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| D008171 | Lung Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |