A Study of the Clinical Benefit of Tobramycin Inhalation Solution

NCT06106789 | Active Not Recruiting

• 1 other identifier: LCYX-YR-20230101
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis; Cystic Fibrosis; Lung Infection

Keywords

Bronchiectasis; Cystic Fibrosis; Lung Infection; Tobramycin inhalation solution; Antimicrobial non-nebulized inhalation preparations; Safety; Efficacy; Economical

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (3)

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.

Drug: Tobramycin inhalation solution

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.

Drug: Tobramycin inhalation solution

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.

Drug: Tobramycin inhalation solution

Interventions

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.

Also known as: Antimicrobial non-nebulized inhalation preparations

Bronchiectasis; Cystic fibrosis; Multidrug-resistant bacterial lung infections

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen or admitted to the hospital (including outpatient, emergency, and inpatient) from January 1, 2021 - December 31, 2023, including: 1. Patients with bronchiectasis combined with P. aeruginosa infection: nebulized inhaled antimicrobials to clear pathogens or to reduce pathogen load; 2. Patients with cystic fibrosis combined with P. aeruginosa infection: nebulized inhaled antimicrobials to clear pathogens or to reduce pathogen load; 3. Patients with multidrug-resistant bacterial lung infections using inhaled antimicrobials as an adjunctive therapeutic regimen to intravenous administration.

You may qualify if:

• Bronchiectasis
• Patients with a past medical history or a diagnosis of bronchiectasis in the current case;
• Patients seen or admitted to the hospital from 1 January 2021 to 31 December 2023 (including outpatient, emergency, and inpatient);
• Case record of at least 1 course of treatment (continuous administration for 28 days) with tobramycin inhalation solution or other antibiotic nebulisation;
• Patients with a positive copper-green test at the first visit.
• Cystic fibrosis
• Patients with a past medical history or a diagnosis of cystic fibrosis in the current case;
• Patients who were seen or admitted to the hospital from 1 January 2021 to 31 December 2023 (including outpatient, emergency, and inpatient);
• Case record of at least 1 course of treatment (continuous administration for 28 days) with tobramycin inhalation solution or other antibiotic nebulisation;
• Patients with a positive copper-green test at the first visit.
• Multidrug-resistant bacterial lung infections
• Patients with a diagnosis of pulmonary infection;
• Patients admitted to the hospital from 1 January 2021 to 31 December 2023 (only inpatients were included);
• Case records with completion of at least 3 days of treatment with tobramycin inhalation solution or other antibiotic nebulisation;
• The patient tested positive for pathogens at least once during the period of medication.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Rui Yang,MD

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Bronchiectasis; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Rui Yang, MD

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of pharmacy

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 30, 2023
• Study Start: April 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: October 30, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)