UMIN-CTR Clinical Trial

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
Last 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
Email	gakkai@gogomotty.com

Public contact
1st 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
Email	gakkai@gogomotty.com

Sponsor
Institute	Koto hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035097