UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Optimization of intravenous vancomycin treatment schedule for pediatric population with Monte Carlo Simulation
Title of the study (Brief title)	Optimization of intravenous vancomycin treatment schedule for pediatric population with Monte Carlo Simulation
Region	Japan

Condition
Condition	Patients under 18 years old who were administered intravenous vancomycin in Department of Pediatrics or Department of Pediatric Cardiology in our institute between April 1st 2011 and March 31st 2016.
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the optimal treatment schedule of vancomycin for pediatric patients with Monte Carlo Simulation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The proportion of the patients who achieved more than 400 of AUC/MIC in the present treatment strategy in our institute.
Key secondary outcomes	To compare the duration required for body temperature to be normalized between the populations with AUC/MIC above 400 and below 400. With Monte Carlo simulation, we will optimize the treatment strategy of vancomycin so that more than 90% of the patients achieve AUC/MIC more than 400.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who were administered intravenous vancomycin in Department of Pediatrics or Department of Pediatric Cardiology between April 1st 2011 and March 31st 2016. Age under 18 years when vancomycin was initiated. Written informed consent is obtained.
Key exclusion criteria	Patients with renal dysfunction. Data unavailability exists. Lack of informed consent.
Target sample size	100

Research contact person
Name of lead principal investigator	Reo Tanoshima
Organization	Yokohama City University
Division name	Department of Pediatrics
Address	Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	(+81)45-787-2800
Email	tanotch@yokohama-cu.ac.jp

Public contact
Name of contact person	Reo Tanoshima
Organization	Yokohama City University
Division name	Department of Pediatrics
Address	Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	(+81)45-787-2800
Homepage URL
Email	tanotch@yokohama-cu.ac.jp

Sponsor
Institute	Department of Pediatrics, Yokohama City University
Institute
Department

Funding Source
Organization	Department of Pediatrics, Yokohama City University
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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 19 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 05 Month 12 Day
Anticipated trial start date	2016 Year 05 Month 12 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	Pediatric patients who were administered vancomycin between April 1st 2011 to March 31st 2016 in Department of Pediatrics or Department of Pediatric Cardiology.

Management information
Registered date	2016 Year 05 Month 18 Day
Last modified on	2018 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025755