UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028704
Receipt number R000032861
Scientific Title analysis of antibiotics concentration in tissue
Date of disclosure of the study information 2017/08/17
Last modified on 2017/08/17 13:53:57

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Basic information

Public title

analysis of antibiotics concentration in tissue

Acronym

analysis of antibiotics concentration in tissue

Scientific Title

analysis of antibiotics concentration in tissue

Scientific Title:Acronym

analysis of antibiotics concentration in tissue

Region

Japan


Condition

Condition

tonsilitis, sinusitis, otitis media

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

we investigate the concentration of antibiotics in tissue.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

time course of concentration antibiotics
of tissue

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patinets who have indication of surgery

Key exclusion criteria

patients who do want join the research

Target sample size

54


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sho Kanzaki

Organization

Keio university

Division name

department of otolarynoglogy

Zip code


Address

35 Shinanomachi

TEL

0353633827

Email

skan@keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sho Kanzaki

Organization

Keio University School of medicine

Division name

Otolaryngology

Zip code


Address

35 Shinanomachi Shinjuku

TEL

0353633827

Homepage URL


Email

skan@keio.jp


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

self

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


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

2017 Year 08 Month 17 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

Suspended

Date of protocol fixation

2010 Year 09 Month 27 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 27 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

no


Management information

Registered date

2017 Year 08 Month 17 Day

Last modified on

2017 Year 08 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032861


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name