UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056338 |
|---|---|
| Receipt number | R000064365 |
| Scientific Title | Evaluation of skin commensal bacterial contamination in two sets of blood cultures collected from a single site. |
| Date of disclosure of the study information | 2024/12/09 |
| Last modified on | 2025/12/03 14:17:36 |
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Basic information
Public title
Evaluation of skin commensal bacterial contamination in two sets of blood cultures collected from a single site.
Acronym
Evaluation of contamination in two sets of blood cultures from a single site.
Scientific Title
Evaluation of skin commensal bacterial contamination in two sets of blood cultures collected from a single site.
Scientific Title:Acronym
Evaluation of contamination in two sets of blood cultures from a single site.
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether differences exist in the detection of indigenous skin bacteria in two sets of blood samples collected from one location, one set containing first blood and the other set not containing first blood, and to determine whether two sets of blood culture samples should be collected from one location.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate blood culture results from a set that includes first-flow blood and from a set that does not include first-flow blood.
Key secondary outcomes
Clinical course of the patient after fever, results of laboratory tests such as blood counts, biochemical tests, etc., other than blood cultures, and patient survival information
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
Patients with hematological diseases admitted to the 5th floor South Ward, Department of Hematology and Oncology, Anjo Shosei Hospital
Key exclusion criteria
Patients deemed inappropriate as research subjects by the principal investigator
Target sample size
2400
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Sawa |
Organization
Anjo Kosei Hospital
Division name
Department of Hematology
Zip code
446-8602
Address
Higashihirokute28 Anjo-cho, Anjo, Aichi
TEL
0566752111
msawa@wine.plala.or.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Miyao |
Organization
Anjo Kosei Hospital
Division name
Department of Hematology
Zip code
446-8602
Address
Department of Hematology,
TEL
0566752111
Homepage URL
koutarou380@yahoo.co.jp
Sponsor or person
Institute
Anjo Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
no funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Anjo Kosei Hospital
Address
Higashihirokute28 Anjo-cho, Anjo, Aichi
Tel
0566752111
kenkyu@kosei.anjo.aichi.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 | 12 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
When blood cultures are collected from a single site, observe the difference in the detection rate of indigenous skin bacteria between the first set of blood cultures including the first blood flow and the second set of blood cultures excluding the first blood flow.
Management information
Registered date
| 2024 | Year | 12 | Month | 02 | Day |
Last modified on
| 2025 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064365
