UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the optimal dosing regimen of daptomycin based on PK-PD
Title of the study (Brief title)	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

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	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

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	Hospital patients receiving daptomycin
Key exclusion criteria	Patients receiving hemodialysis
Target sample size	50

Research contact person
Name of lead principal investigator	MATSUMOTO KAZUAKI
Organization	Graduate School of Medical and Dental Sciences Kagoshima University
Division name	Clinical Pharmacy and Pharmacology
Address	8-35-1 Sakuragaoka, Kagoshima, Kagoshima
TEL	099-275-5543
Email

Public contact
Name of contact person
Organization	Graduate School of Medical and Dental Sciences Kagoshima University
Division name	Clinical Pharmacy and Pharmacology
Address	8-35-1 Sakuragaoka, Kagoshima, Kagoshima
TEL	099-275-5543
Homepage URL
Email

Sponsor
Institute	Kagoshima University 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	None
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	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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011417