UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031495 |
|---|---|
| Receipt number | R000035097 |
| Scientific Title | Prospective investigation of efficacy for blood culture of a new antiseptic Olanexidine Gluconate 1.5%. |
| Date of disclosure of the study information | 2018/02/28 |
| Last modified on | 2019/03/29 11:42:49 |
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Basic information
Public title
Prospective investigation of efficacy for blood culture of a new antiseptic Olanexidine Gluconate 1.5%.
Acronym
Prospective investigation of efficacy for blood culture of a new antiseptic Olanexidine Gluconate 1.5%.
Scientific Title
Prospective investigation of efficacy for blood culture of a new antiseptic Olanexidine Gluconate 1.5%.
Scientific Title:Acronym
Prospective investigation of efficacy for blood culture of a new antiseptic Olanexidine Gluconate 1.5%.
Region
| Japan |
Condition
Condition
Case of suspected blood stream infection with blood culture.
Classification by specialty
| Medicine in general | Surgery in general | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to measure the efficacy and the safety of a new antiseptic Olanexidine gluconate in these patients with blood stream infection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is the ratio of contamination.
Key secondary outcomes
Secondary outcome is determined to assess the rate of any adverse effect such as vital sign, subjective and objective symptom, erythema or irritation of the skin.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Apply 1.5% Olamexidine gluconate twice, then dry it before applying blood culture.
Blood cultures are taken 2 sets and the result is judged as contamination with the result.
The skin site exposed to 1.5% Olamexidine gluconate are inspected any adverse effect such as vital sign, subjective and objective symptom, erythema or irritation of the skin.
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
(1)Case in which blood culture was carried out on suspicion of bloodstream infection over 38 degrees or clinically carried out in Kodo hospital during daytime on weekdays.
(2)Patients who understand the contents of the examination, and can observe it
(3)Agreement from patients or subsutituted person
Key exclusion criteria
(1)Patients already receiving antibiotic treatment
(2)Patients who had an allergy to a study drug or gluconic acid chlorhexidine
(3)Patients who judged inappropriate cases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Koto hospital
Division name
Division of emergency
Zip code
1360072
Address
6-8-5 oojima koto-ku tokyo 136-0072
TEL
03-3685-2166
gakkai@gogomotty.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Koto hospital
Division name
Division of emergency
Zip code
1360072
Address
6-8-5 oojima koto-ku tokyo 136-0072
TEL
03-3685-2166
Homepage URL
gakkai@gogomotty.com
Sponsor or person
Institute
Koto 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
Koto hospital
Address
6-8-5 oojima koto-ku tokyo 136-0072
Tel
03-3685-2166
miurakunihisa@yahoo.co.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
| 2018 | Year | 02 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2018 | Year | 02 | Month | 27 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035097
