UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009743 |
|---|---|
| Receipt number | R000011417 |
| Scientific Title | Evaluation of the optimal dosing regimen of daptomycin based on PK-PD |
| Date of disclosure of the study information | 2013/01/11 |
| Last modified on | 2016/07/11 09:24:14 |
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Basic information
Public title
Evaluation of the optimal dosing regimen of daptomycin based on PK-PD
Acronym
The optimal dosing regimen of daptomycin
Scientific Title
Evaluation of the optimal dosing regimen of daptomycin based on PK-PD
Scientific Title:Acronym
The optimal dosing regimen of daptomycin
Region
| Japan |
Condition
Condition
MRSA infection
Classification by specialty
| Hematology and clinical oncology | Infectious disease | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Orthopedics | Cardiovascular surgery |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to investigate Cmax/MIC and AUC/MIC values of daptomycin to MRSA and to uncover the threshold concentration in the occurrence of side effects.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
PK-PD analysis of daptomycin is performed. The Cmax/MIC and AUC/MIC values are determined. Furthermore, we assess the relationship between daptomycin blood concentration and side effects to specify the target concentration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
On Days 3-7 after initial administration, venous blood samples
were drawn just before the next administration and after one hour i.v. infusion.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospital patients receiving daptomycin
Key exclusion criteria
Patients receiving hemodialysis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MATSUMOTO KAZUAKI |
Organization
Graduate School of Medical and Dental Sciences Kagoshima University
Division name
Clinical Pharmacy and Pharmacology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Kagoshima
TEL
099-275-5543
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medical and Dental Sciences Kagoshima University
Division name
Clinical Pharmacy and Pharmacology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Kagoshima
TEL
099-275-5543
Homepage URL
Sponsor or person
Institute
Kagoshima University hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
鹿児島大学病院(鹿児島県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 11 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 10 | 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
| 2013 | Year | 01 | Month | 10 | Day |
Last modified on
| 2016 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011417
