UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054915 |
|---|---|
| Receipt number | R000062736 |
| Scientific Title | Epidemiological study for patients with bacteremia in Toyama, Japan: multicenter prospective observational study |
| Date of disclosure of the study information | 2024/07/12 |
| Last modified on | 2026/03/03 07:54:12 |
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Basic information
Public title
Epidemiological study for patients with bacteremia in Toyama, Japan: multicenter prospective observational study
Acronym
Epidemiological study for patients with bacteremia in Toyama, Japan
Scientific Title
Epidemiological study for patients with bacteremia in Toyama, Japan: multicenter prospective observational study
Scientific Title:Acronym
Epidemiological study for patients with bacteremia in Toyama, Japan
Region
| Japan |
Condition
Condition
Bacteremia
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
-To investigate clinical and microbiological features in patients with bacteremia, including backgrounds, outcomes, identified pathogens, antimicrobial susceptibilities, and risk factors for clinical failure.
-To propose the appropriate initial assessment and empirical treatment for patients with bacteremia.
Basic objectives2
Others
Basic objectives -Others
Backgrounds, outcomes, identified pathogens and drug resistance, antimicrobial susceptibilities, adherence to practice bundles, etc.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Clinical failure within 30 days after the onset of bacteremia (fulfilling at least 1 of the following indicators; recurrent bacteremia or initial infection, local suppurative complication, metastatic infection, death due to any cause).
2) Source of bacteremia
3) Identified pathogens and drug resistance
Key secondary outcomes
1) Clinical management of patients with bacteremia during the episode
-Antibiotic therapy used during the episodes (empirical and targeted)
-Non antibiotic therapy/support therapy used during the episode.
-Frequency of focus search and adequate control
2) Developing and validating a predictive model for mortality.
3) Quality indicators in the management of bacteremia.
4) Interventions made by antimicrobial stewardship team (AST)
-Frequency and type of interventions made by AST
-Impact of these interventions in the management and prognosis of episodes.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Any bacteria isolated from blood culture.
2. over 18 years old.
Key exclusion criteria
(1) The patient was previously included in the same cohort of this study, during the study period.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Yamamoto |
Organization
University of Toyama
Division name
Clinical infectious diseases
Zip code
930-0194
Address
Sugitani 2630, Toyama, Japan
TEL
+81764347245
yamamoto@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Nagaoka |
Organization
University of Toyama
Division name
Clinical infectious diseases
Zip code
930-0194
Address
Sugitani 2630, Toyama, Japan
TEL
+81764347245
Homepage URL
knagaoka@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Kentaro Nagaoka
Funding Source
Organization
No funding was received towards this work.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Toyama
Address
Sugitani 2630, Toyama, Japan
Tel
+81764158857
rinri@adm.u-toyama.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
| 2024 | Year | 07 | Month | 12 | 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
1532
Results
This multicenter observational enrolled a total of 1,532 patients were enrolled. Of these, 169 cases were classified as contamination.
Clinical outcomes during the 30-day observation period were as follows: 288 clinical failure (19%), 141 deaths (10%).
Computed tomography (CT) imaging was performed after the onset of bacteremia in 1,163 patients (83%).
Results date posted
| 2026 | Year | 03 | Month | 03 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Patient enrollment was completed on May 31, 2025, and the observation period concluded on July 1, 2025. Following data entry from each participating institution, data cleaning and data management procedures were conducted.
After completion of these processes in October 2025, additional statistical analyses were performed, and approximately four months were required for manuscript preparation.
As revisions to the results section may be necessary during the peer-review process, detailed reporting of the study findings is planned after formal publication.
Accordingly, the first public disclosure of the study results is expected to occur approximately one year after completion of the observational study period.
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 30 | Day |
Other
Other related information
-This study is a prospective observational study.
-The study will be performed in 7 hospitals throughout Toyama prefecture, Hokuriku region in Japan. In all the institutions, antimicrobial stewardship team (AST) monitor the daily clinical and microbiological data from all the inpatients who developed bacteremia, and propose the candidates of appropriate antibiotics regimen via electronic chart, if necessary. Microbiologists from Department of Clinical Infectious Diseases, Toyama University Hospital, visit each institution weekly (biweekly for Nishi General Hospital), and support activities of AST.
-All consecutive patients with bacteremia diagnosed at the participating hospitals will be eligible. These patients will be identified daily by reviewing local microbiological laboratory reports at each site. Each patient with any positive blood culture results will be evaluated for inclusion and exclusion criteria.
-All enrolled patients will be followed for a period of 30 days after inclusion.
Management information
Registered date
| 2024 | Year | 07 | Month | 09 | Day |
Last modified on
| 2026 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062736
