UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of TDM-guided treatment with daptomycin based on PK/PD theory by measurement of plasma concentration of daptomycin.
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Akira Ukimura
Organization	Osaka Medical College Hospital
Division name	Infection Control Team
Address	2-7 Daigakumachi Takatsuki-city, Osaka
TEL	072-683-1221
Email	in3011@poh.osaka-med.ac.jp

Public contact
Name of contact person	Akira Ukimura
Organization	Osaka Medical College Hospital
Division name	Infection Control Team
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 05 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014042