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.
Study 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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Total Adverse Reaction Incidence Rate — Through study completion，up to half a year. 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.
Pathogen clearance — Through study completion，up to half a year. 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.
Average hospitalization cost per visit — Through study completion，up to half a year. 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.