UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005906
Receipt number R000006985
Scientific Title analysis on antibiotics concentration of organ
Date of disclosure of the study information 2012/02/14
Last modified on 2019/09/18 04:47:40

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Basic information

Public title

analysis on antibiotics concentration of organ

Acronym

antibiotics concentration of organ

Scientific Title

analysis on antibiotics concentration of organ

Scientific Title:Acronym

antibiotics concentration of organ

Region

Japan


Condition

Condition

infectious diseases in sinusitis and tosilitis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

measurement of antibiotics concentration in organs

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

concentration of antibiotics

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Five days after taking antibiotics

Interventions/Control_2

Seven days after taking antibiotics

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

20 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

patients who takes antibiotics before sugery

Key exclusion criteria

patinets whp does not take antibiotics

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sho Kanzaki

Organization

Keio University Medical School

Division name

Otolarynnogology

Zip code


Address

35 Shinanomachi Shinjuku Tokyo

TEL

0333531211

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Keio University, School of Medicine

Division name

Otolaryngology

Zip code


Address


TEL


Homepage URL


Email

skan@a7.keiio.jp


Sponsor or person

Institute

keio University Medical School

Institute

Department

Personal name



Funding Source

Organization

special grant

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


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

2012 Year 02 Month 14 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

Terminated

Date of protocol fixation

2011 Year 05 Month 18 Day

Date of IRB

2010 Year 09 Month 27 Day

Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2017 Year 08 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 07 Month 01 Day

Last modified on

2019 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006985


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name