A Study of the Clinical Benefit of Tobramycin Inhalation Solution

October 24, 2023 updated by: Rui Yang, Qianfoshan Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China
        • Rui Yang,MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.

Other Names:
  • Antimicrobial non-nebulized inhalation preparations
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

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.

Other Names:
  • Antimicrobial non-nebulized inhalation preparations
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

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.

Other Names:
  • Antimicrobial non-nebulized inhalation preparations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Adverse Reaction Incidence Rate
Time Frame: 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.
Through study completion，up to half a year.
Pathogen clearance
Time Frame: 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.
Through study completion，up to half a year.
Average hospitalization cost per visit
Time Frame: 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.
Through study completion，up to half a year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Investigators

  • Principal Investigator: Rui Yang, MD, Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCYX-YR-20230101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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