UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on pharmacokinetics and dosage adaptation of meropenem in pediatric patients receiving continuous hemodiafiltration
Title of the study (Brief title)	Pharmacokinetic study of meropenem in pediatric patients with CHDF
Region	Japan

Condition
Condition	Infectious diseases
Classification by specialty	Medicine in general Nephrology Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, pediatric patients divide two groups; CHDF group and control group, and blood samples are collected. We evaluate the differences of pharmacokinetics and pharmacodynamics of meropenem between two groups.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pharmacokinetic parameters (clearance, volume of distribution, half life) of meropenem
Key secondary outcomes

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	0 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	1) 15 years old or younger 2) Patient who is treated with meropenem intravenously 3) Patient who is received continuous haemodiafiltration 4) Informed consent by the document
Key exclusion criteria	1) Other clinical difficulties in this study
Target sample size	70

Research contact person
Name of lead principal investigator	Keita Hirai
Organization	school of pharmaceutical science, university of Shizuoka graduate school
Division name	Department of clinical pharmacology and genetics
Address	52-1 Yada Suruga-ku Shizuoka-city Shizuoka Japan
TEL	054-264-5674
Email	hiraik@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	Keita Hirai
Organization	school of pharmaceutical science, university of Shizuoka graduate school
Division name	Department of clinical pharmacology and genetics
Address	52-1 Yada Suruga-ku Shizuoka-city Shizuoka Japan
TEL	054-264-5674
Homepage URL
Email	hiraik@u-shizuoka-ken.ac.jp

Sponsor
Institute	Department of clinical pharmacology and genetics, school of pharmaceutical science, university of Shizuoka graduate school
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Shizuoka children's hospital
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	静岡県立こども病院(静岡県)/Shizuoka children's hospital

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 09 Month 01 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	In this study, pediatric patients divide two groups; CHDF group and control group, and blood samples are collected. We evaluate the differences of pharmacokinetics and pharmacodynamics of meropenem between two groups.

Management information
Registered date	2014 Year 08 Month 20 Day
Last modified on	2018 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017337