Clinical trial NCT06106789: A Study of the Clinical Benefit of Tobramycin Inhalation Solution
Official title: A Study of the Clinical Benefit of Tobramycin Inhalation Solution
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bronchiectasis
Cystic Fibrosis
Lung Infection
Keywords: Bronchiectasis
Cystic Fibrosis
Lung Infection
Tobramycin inhalation solution
Antimicrobial non-nebulized inhalation preparations
Safety
Efficacy
Economical
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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 outcomes:
measure: Total Adverse Reaction Incidence Rate
timeFrame: Through study completion，up to half a year.
measure: Pathogen clearance
timeFrame: Through study completion，up to half a year.
measure: Average hospitalization cost per visit
timeFrame: Through study completion，up to half a year.
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Rui Yang,MD
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Rui Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: