UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062785 |
|---|---|
| Receipt number | R000071883 |
| Scientific Title | Prevention of blood culture contamination in adherent patients to revised bundle protocol including routine use of sterile globes and sterile drape for collecting blood sample: comparison with the control period during which previous bundle was followed using propensity score matching |
| Date of disclosure of the study information | 2026/09/07 |
| Last modified on | 2026/09/02 16:26:12 |
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Basic information
Public title
Prevention of blood culture contamination with the introduction of the bundle intervention for the collection of blood culture sample: comparison using Propensity score matching
Acronym
Prevention of blood culture contamination with the introduction of the bundle intervention for collecting blood sample
Scientific Title
Prevention of blood culture contamination in adherent patients to revised bundle protocol including routine use of sterile globes and sterile drape for collecting blood sample: comparison with the control period during which previous bundle was followed using propensity score matching
Scientific Title:Acronym
Prevention of blood culture contamination in adherent patients to revised bundle protocol including routine use of sterile globes and sterile drape for collecting blood sample
Region
| Japan |
Condition
Condition
Bacteremia
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to demonstrate the efficacy of the blood culture contamination preventive bundle protocol including routine use of sterile globes and sterile drape.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood culture contamination rate per set
Key secondary outcomes
Adherence rate of the bundle protocol
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Routine use of sterile globes and sterile drape for the collection of samples of blood culture
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adherent patients to the blood culture contamination preventive bundle protocol with the collection of 2 or more sets in blood culture
Key exclusion criteria
Blood culture is collected for only single set or even one element of the bundle protocol is not achieved
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Takesue |
Organization
Chita Peninsula Rinku Hospital
Division name
Department of Infectious Disease
Zip code
479-8510
Address
3-3-3, Asukadai, Tokoname, Aichi, Japan
TEL
0569-35-3170
takesuey@jyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Yamada |
Organization
Chita Peninsula Rinku Hospital
Division name
Department of Respiratory Medicine
Zip code
479-8510
Address
3-3-3, Asukadai, Tokoname, Aichi, Japan
TEL
0569-35-3170
Homepage URL
ka.yamada@chitahantogmo.or.jp
Sponsor or person
Institute
Chita Peninsula Rinku Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Chita Peninsula Rinku Hospital
Address
3-3-3 Asukadai, Tokoname, 479-8510, Aichi, Japan
Tel
0569-35-3170
takesuey@hyo-med.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
| 2026 | Year | 09 | Month | 07 | 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
| 2025 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071883
