UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030152 |
|---|---|
| Receipt number | R000034428 |
| Scientific Title | Effect evaluation of alcohol-based disinfectant on pathogen contained in body fluid |
| Date of disclosure of the study information | 2017/12/26 |
| Last modified on | 2020/12/04 10:06:31 |
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Basic information
Public title
Effect evaluation of alcohol-based disinfectant on pathogen contained in body fluid
Acronym
Effect evaluation of alcohol-based disinfectant
Scientific Title
Effect evaluation of alcohol-based disinfectant on pathogen contained in body fluid
Scientific Title:Acronym
Effect evaluation of alcohol-based disinfectant
Region
| Japan |
Condition
Condition
Healthcare-acquired infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigated whether pathogens present in mucus such as sputum acquire resistance to alcohol-based disinfectants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Log reduction value of the pathogens on the hand after the hand hygiene
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers over 20 years old.
Key exclusion criteria
Exclusion criteria were that there was no skin damage (abrasion, inflammation, etc.) on the fingers/hands and there was no history of hypersensitivity to the disinfectant to be used.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki Nakaya |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Infectious Diseases
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5326
tnakaya@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Nakaya |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Infectious Diseases
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5326
Homepage URL
tnakaya@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
This work was supported by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology, Japan (JSPS).
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 12 | Month | 26 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
We evaluated the resistance of pathogens in artificial mucus preparations to alcohol-based disinfectants.
The resistance of pathogens to alcohol-based disinfectants was examined with the inactivation test, which was conducted according to established guidelines.
Management information
Registered date
| 2017 | Year | 11 | Month | 28 | Day |
Last modified on
| 2020 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034428
