UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055683 |
|---|---|
| Receipt number | R000063428 |
| Scientific Title | A Multi-center Prospective Study on Improving the Diagnostic Process for Pneumonia in Elderly Patients |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/09/15 13:46:37 |
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Basic information
Public title
A Multi-center Prospective Study on Improving the Diagnostic Process for Pneumonia in Elderly Patients
Acronym
Study on Improving Pneumonia Diagnosis in the Elderly
Scientific Title
A Multi-center Prospective Study on Improving the Diagnostic Process for Pneumonia in Elderly Patients
Scientific Title:Acronym
Study on Improving Pneumonia Diagnosis in the Elderly
Region
| Japan |
Condition
Condition
Pneumonia in the Elderly
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve the diagnostic process of pneumonia in the elderly by identifying the percentage of cases that meet the diagnostic criteria for aspiration pneumonia and have imaging findings consistent with aspiration pneumonia on chest CT imaging evaluation.
Basic objectives2
Others
Basic objectives -Others
Improvement of diagnostic accuracy for aspiration pneumonia in elderly patients. Enhancement of the diagnostic process using chest CT image evaluation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of cases meeting diagnostic criteria for aspiration pneumonia that have imaging findings consistent with aspiration pneumonia on evaluation of chest CT images
Key secondary outcomes
Differences in clinical characteristics between groups with and without imaging findings consistent with aspiration pneumonia
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 65 years of age or older
Patients hospitalized with pneumonia at the target facility
Patients who have been fully informed about their participation in this study, and who have given their or their surrogate's free and voluntary written consent based on full understanding of the study
Key exclusion criteria
Patients with complications of malignancy
Patients with suspected interstitial pneumonia
Patients with antimicrobial infections
Patients with COVID-19
Patients under treatment with immunosuppressive agents
Other patients who are deemed inappropriate to participate in this study by the principal investigator or research coordinator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akihito |
| Middle name | |
| Last name | Ueda |
Organization
Medical Corporation Toujinkai, Fujitate Hospital
Division name
Department of internal medicine
Zip code
5350002
Address
5-4-24 Omiya Asahi-ku, Osaka-shi, Osaka-hu
TEL
0669551221
akihitoueda@gmail.com
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Ueda |
Organization
Medical Corporation Toujinkai, Fujitate Hospital
Division name
Department of internal medicine
Zip code
5350002
Address
5-4-24 Omiya Asahi-ku, Osaka-shi, Osaka-hu
TEL
0669551221
Homepage URL
akihitoueda@gmail.com
Sponsor or person
Institute
Medical Corporation Toujinkai, Fujitate Hospital
Institute
Department
Personal name
Funding Source
Organization
Medical Corporation Toujinkai, Fujitate Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Toujinkai, Fujitate Hospital
Address
5-4-24 Omiya Asahi-ku, Osaka-shi, Osaka-hu
Tel
0669551221
akihitoueda@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study will begin patient enrollment on October 1, 2024. The study aims to improve the diagnostic process for elderly patients with pneumonia, and will use chest CT imaging evaluation to improve the diagnostic accuracy of aspiration pneumonia. This is a multicenter study and aims to enroll a target number of 300 patients. The study period is scheduled to end on June 30, 2027. Study results are expected to contribute to the improvement of pneumonia diagnosis in the elderly care.
Management information
Registered date
| 2024 | Year | 10 | Month | 01 | Day |
Last modified on
| 2024 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063428
