UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018325
Receipt number R000021208
Scientific Title Two bacteria isolated from blood culture with analysis by TOF-MS
Date of disclosure of the study information 2015/07/15
Last modified on 2016/07/15 15:45:47

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Basic information

Public title

Two bacteria isolated from blood culture with analysis by TOF-MS

Acronym

Two bacteria positive blood with TOF-MS

Scientific Title

Two bacteria isolated from blood culture with analysis by TOF-MS

Scientific Title:Acronym

Two bacteria positive blood with TOF-MS

Region

Japan


Condition

Condition

bacteremia

Classification by specialty

Medicine in general Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analysis the patients whom two bacteria isolated from blood by TOF-MS

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Bacteria isolation, antibiotics effectiveness

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

15 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

two more bacteria were isolated from blood

Key exclusion criteria

None

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masafumi SEKI

Organization

Tohoku Pharmaceutical Unversity Hospital

Division name

Respiratory and Infection

Zip code


Address

Sendai

TEL

022-259-1221

Email

seki@hosp.tohoku-pharm.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masafumi SEKI

Organization

Tohoku Pharmaceutical Unversity Hospital

Division name

Respiratory and Infection

Zip code


Address

Sendai

TEL

022-259-1221

Homepage URL


Email

seki@hosp.tohoku-pharm.ac.jp


Sponsor or person

Institute

Tohoku Pharmaceutical Unversity Hospital

Institute

Department

Personal name



Funding Source

Organization

Scientific budget

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 07 Month 15 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

Preinitiation

Date of protocol fixation

2015 Year 07 Month 08 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 08 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Sampling from inpatients.


Management information

Registered date

2015 Year 07 Month 15 Day

Last modified on

2016 Year 07 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021208


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name