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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009743
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kagoshima University hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011417

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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