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
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
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
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
