UMIN-CTR Clinical Trial

Basic information
Public title	Influence of pre-aspiration antibiotic use on the positive rate of culture of liver abscess
Acronym	Influence of pre-aspiration antibiotic use on the positive rate of culture of liver abscess
Scientific Title	Influence of pre-aspiration antibiotic use on the positive rate of culture of liver abscess
Scientific Title:Acronym	Influence of pre-aspiration antibiotic use on the positive rate of culture of liver abscess
Region	Japan

Condition
Condition	liver abscess
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Abscess puncture is divided into two groups: one before the administration of antibiotics and one after the administration of antibiotics, and it is examined whether the timing of this puncture affects the culture positive rate.
Basic objectives2	Others
Basic objectives -Others	To verify the sensitivity specificity of liver puncture culture to blood culture. To examine the effect of knowing the results of liver culture on the therapeutic effect of patients
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Liver abscess puncture culture result,
Key secondary outcomes	death at discharge, sepsis, blood culture result,Length of stay in hospital

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with liver abscess
Key exclusion criteria	none
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Keito Middle name Last name Shinmoto
Organization	Tokyo Bay Urayasu/Ichikawa Medical Center
Division name	Medical Department
Zip code	2790001
Address	3-4-32 Todaijima, Urayasu-City, Chiba
TEL	0473513101
Email	keito.shinmoto@gmail.com

Public contact
Name of contact person	1st name Keito Middle name Last name Shinmoto
Organization	Tokyo Bay Urayasu/Ichikawa Medical Center
Division name	General Internal Medicine
Zip code	2790001
Address	3-4-32 Todaijima, Urayasu-City, Chiba
TEL	0473513101
Homepage URL
Email	keito.shinmoto@gmail.com

Sponsor
Institute	Tokyo Bay Urayasu/Ichikawa Medical Center
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Bay Urayasu/Ichikawa Medical Center
Address	3-4-32 Todaijima, Urayasu-City, Chiba
Tel	0473513101
Email	j-kohyama@jadecom.or.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	2020 Year 03 Month 04 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	72
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	2020 Year 03 Month 04 Day
Date of IRB	2020 Year 02 Month 28 Day
Anticipated trial start date	2020 Year 03 Month 04 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Perform a medical chart review and extract patient data

Management information
Registered date	2020 Year 03 Month 04 Day
Last modified on	2020 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045273