UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058195 |
|---|---|
| Receipt number | R000066494 |
| Scientific Title | A Multicenter Epidemiological Study on the Causative Microorganisms of Pneumonia in Hemodialysis Patients |
| Date of disclosure of the study information | 2025/06/20 |
| Last modified on | 2025/06/16 17:28:42 |
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Basic information
Public title
A Multicenter Epidemiological Study on the Causative Microorganisms of Pneumonia in Hemodialysis Patients
Acronym
Microorganisms Causing Pneumonia in Dialysis Patients
Scientific Title
A Multicenter Epidemiological Study on the Causative Microorganisms of Pneumonia in Hemodialysis Patients
Scientific Title:Acronym
Microorganisms Causing Pneumonia in Dialysis Patients
Region
| Japan |
Condition
Condition
Pneumonia
Classification by specialty
| Nephrology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the causative microorganisms of pneumonia in hemodialysis patients
Basic objectives2
Others
Basic objectives -Others
epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distribution of causative microorganisms of pneumonia in hemodialysis patients
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients diagnosed with pneumonia
Key exclusion criteria
Patients who developed pneumonia during hospitalization or had clearly non-infectious pneumonia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Yoshifuji |
Organization
Keio University
Division name
Department of Infectious Diseases, School of Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
keioinfectiousdiseasebranch@gmail.com
Public contact
Name of contact person
| 1st name | Norihiro |
| Middle name | |
| Last name | Nukui |
Organization
Keio University
Division name
Department of Infectious Diseases, School of Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
Homepage URL
keioinfectiousdiseasebranch@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
JAPANESE ASSOCIATION OF DIALYSIS PHYSICIANS
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
+81-3-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
| 2025 | Year | 06 | Month | 20 | 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 | 05 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For subjects clinically diagnosed with pneumonia, a FilmArray Respiratory Panel or Pneumonia Panel will be performed in addition to routine sputum culture. Collaborating institutions will record baseline information on patient background, admission laboratory data, and 28-day outcomes in the standardized case report form.
Management information
Registered date
| 2025 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066494
