UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of Ethanol lock therapy for Central Venous Catheter-Related Bloodstream Infection
Title of the study (Brief title)	Study of Ethanol lock therapy for CRBSI
Region	Japan

Condition
Condition	catheter related blood stream infection
Classification by specialty	Infectious disease Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of the effectiveness of ethanol lock for CRBSI
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Improvement of CRBSI
Key secondary outcomes	Safety of ethanol lock

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ethanol lock
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	Not applicable
Age-upper limit	20 years-old >
Gender	Male and Female
Key inclusion criteria	CRBSI patients removal of the CVC is undesirable. Patients with fever of unknown origin and cannot be diagnosis of CRBSI.
Key exclusion criteria	Patients have allergy for ethanol. Patients have severe liver disfunction, total bilirubin 3 mg / dL or more, ascites difficult management, severe bleeding tendency.
Target sample size	10

Research contact person
Name of lead principal investigator	Kimiyoshi Sakaguchi
Organization	Hamamatsu University School of Medicine
Division name	Department of Pediatrics
Address	1-20-1 Handayama, Higashi-ward, Hamamatsu
TEL	053-435-2312
Email	k-saka@hama-med.ac.jp

Public contact
Name of contact person	Kimiyoshi Sakaguchi
Organization	Hamamatsu University School of Medicine
Division name	Department of Pediatrics
Address	1-20-1 Handayama, Higashi-ward, Hamamatsu
TEL	053-435-2312
Homepage URL
Email	k-saka@hama-med.ac.jp

Sponsor
Institute	Department of Pediatrics, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Sanofi K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 04 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 02 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 10 Day
Last follow-up date	2017 Year 05 Month 29 Day
Date of closure to data entry	2017 Year 05 Month 29 Day
Date trial data considered complete	2017 Year 05 Month 29 Day
Date analysis concluded	2017 Year 05 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Only one case was registered and there was a deviation from the protocol. We decided that registration of a new case can not be expected in the future and terminated the study.
Other related information

Management information
Registered date	2014 Year 04 Month 10 Day
Last modified on	2017 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015969