UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039692 |
|---|---|
| Receipt number | R000045273 |
| Scientific Title | Influence of pre-aspiration antibiotic use on the positive rate of culture of liver abscess |
| Date of disclosure of the study information | 2020/03/04 |
| Last modified on | 2020/03/04 17:21:19 |
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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
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
keito.shinmoto@gmail.com
Sponsor or person
Institute
Tokyo Bay Urayasu/Ichikawa Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045273
