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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012015
Receipt No. R000014042
Scientific Title Development of TDM-guided treatment with daptomycin based on PK/PD theory by measurement of plasma concentration of daptomycin.
Date of disclosure of the study information 2013/10/21
Last modified on 2016/04/22

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Basic information
Public title Development of TDM-guided treatment with daptomycin based on PK/PD theory by measurement of plasma concentration of daptomycin.
Acronym PK/PD of Daptomycin
Scientific Title Development of TDM-guided treatment with daptomycin based on PK/PD theory by measurement of plasma concentration of daptomycin.
Scientific Title:Acronym PK/PD of Daptomycin
Region
Japan

Condition
Condition Patients with infection by Methicillin resistant Gram-positive cocci.
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We measure daptomycin plasma concentration by high performance liquid chromatography (HPLC) to establish TDM-guided treatment with daptomycin based on PK/PD theory with more safety and efficacy.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We analyze outcome and side effects of patients treated with daptomycin.
Key secondary outcomes We analyze relationship between plasma daptomycin concentration trough and creatine phosphokinase.

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 Single-arm open trial of TDM-guided treatment with daptomycin and measurement of plasma daptomycin concentration of patients infected by methicillin resistant Gram-positive cocci.
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 Patients admitted in Osaka Medical College Hospital with infection by methicillin resistant gram-positive cocci except for pneumonia with agreement of this study.
Key exclusion criteria Nothing
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Ukimura
Organization Osaka Medical College Hospital
Division name Infection Control Team
Zip code
Address 2-7 Daigakumachi Takatsuki-city, Osaka
TEL 072-683-1221
Email in3011@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Ukimura
Organization Osaka Medical College Hospital
Division name Infection Control Team
Zip code
Address 2-7 Daigakumachi Takatsuki-city, Osaka
TEL 072-683-1221
Homepage URL http://hospital.osaka-med.ac.jp/about/dept_list/related_section/kansen_rinsyou.html
Email in3011@poh.osaka-med.ac.jp

Sponsor
Institute Infection control team of Osaka Medical College Hospital
Institute
Department

Funding Source
Organization Department of General Internal Medicine, Osaka Medical College
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 大阪医科大学附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially 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 Open public recruiting
Date of protocol fixation
2013 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 02 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 10 Month 10 Day
Last modified on
2016 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014042

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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