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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031856
Receipt No. R000036378
Scientific Title Current status of antibiotics and immunotherapy for severe infections
Date of disclosure of the study information 2018/04/01
Last modified on 2020/04/26

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Basic information
Public title Current status of antibiotics and immunotherapy for severe infections
Acronym Current status of antibiotics and immunotherapy for severe infections
Scientific Title Current status of antibiotics and immunotherapy for severe infections
Scientific Title:Acronym Current status of antibiotics and immunotherapy for severe infections
Region
Japan

Condition
Condition severe infections
Classification by specialty
Medicine in general Intensive care medicine Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to examine the efficacy and side effects of IVIG administration for patients with severe infectious diseases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ICU mortality rate, ICU treatment period, side effect
Key secondary outcomes

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
1 days-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Between January 1, 2008 and March 30, 2020, we entered the intensive care unit of our hospital and a patient diagnosed as severe infection
Key exclusion criteria When the research subject is refused to participate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Mao
Middle name
Last name Kinoshita
Organization Kyoto Prefectural University of Medicine
Division name Anesthesiology
Zip code 6028566
Address 465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, japan
TEL 0752515633
Email mao6515@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Mao
Middle name
Last name Kinoshita
Organization Kyoto Prefectural University of Medicine
Division name Anesthesiology
Zip code 6028566
Address 465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, japan
TEL 0752515633
Homepage URL
Email mao6515@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
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 Kyoto Prefectural University of Medicine
Address 465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, japan
Tel 0752515633
Email mao6515@koto.kpu-m.ac.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 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2018 Year 03 Month 01 Day
Date of IRB
2018 Year 06 Month 05 Day
Anticipated trial start date
2018 Year 06 Month 06 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 A retrospective observation study will investigate whether there is an effect of improving prognosis for severe infections in our intensive care unit.

Management information
Registered date
2018 Year 03 Month 23 Day
Last modified on
2020 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036378

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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