UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033263 |
|---|---|
| Receipt number | R000037819 |
| Scientific Title | Relationship between trough concentration and therapeutic effect in vancomycin therapy |
| Date of disclosure of the study information | 2018/08/15 |
| Last modified on | 2018/07/04 09:21:50 |
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Basic information
Public title
Relationship between trough concentration and therapeutic effect in vancomycin therapy
Acronym
Relationship between trough concentration and therapeutic effect in vancomycin therapy
Scientific Title
Relationship between trough concentration and therapeutic effect in vancomycin therapy
Scientific Title:Acronym
Relationship between trough concentration and therapeutic effect in vancomycin therapy
Region
| Japan |
Condition
Condition
Infection with MRSA and Enterococcus faecium
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the validity that a pharmacist maintains VCM trough value at appropriately
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluated the efficacy of VMC by a change of CRP
Key secondary outcomes
WBC,neutrophil,body temperature
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
From May,2007 to May,2012
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
(1)20plus
(2)TDM more than twice
Key exclusion criteria
(1)Dialysis patient
(2)In the first TDM vancomycin trough value more than 10ug/ml
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misae TSUBOI |
Organization
Shujitu University
Division name
Laboratory of Drug Infomation Analyses,School of Pharmacy
Zip code
Address
1-6-1 Nishigawara, Naka-ku, Okayama,Japan
TEL
086-271-8409
teshima@shujitu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke TESHIMA |
Organization
Shujitsu University
Division name
Laboratory of Drug Infomation Analyses,School of Pharmacy
Zip code
Address
1-6-1 Nishigawara, Naka-ku, Okayama,Japan
TEL
086-271-8409
Homepage URL
teshima@shujitu.ac.jp
Sponsor or person
Institute
Shujitsu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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 | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2017 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 04 | Day |
Last modified on
| 2018 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037819
