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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024321
Receipt No. R000028012
Scientific Title Dose inidividualization of antimicrobials based on population pharmacokinetic analysis in patients undergoing blood purification therapy
Date of disclosure of the study information 2016/11/01
Last modified on 2019/04/09

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Basic information
Public title Dose inidividualization of antimicrobials based on population pharmacokinetic analysis in patients undergoing blood purification therapy
Acronym Dose inidividualization of antimicrobials based on population pharmacokinetic analysis in patients undergoing blood purification therapy
Scientific Title Dose inidividualization of antimicrobials based on population pharmacokinetic analysis in patients undergoing blood purification therapy
Scientific Title:Acronym Dose inidividualization of antimicrobials based on population pharmacokinetic analysis in patients undergoing blood purification therapy
Region
Japan

Condition
Condition sepsis
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To individualize antimicrobial dose by clarifying pharmacokinetics in patients undergoing blood purification therapy.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To develop population pharmacokinetic model
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
18 years-old <=
Age-upper limit
150 years-old >
Gender Male and Female
Key inclusion criteria Undergoing blood purification therapy
Key exclusion criteria In state with impossible sampling of blood for measurement of blood antimicrobial concentration
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Hideyuki
Middle name
Last name Saito
Organization Kumamoto University Hospital
Division name Department of Pharmacy
Zip code 860-8556
Address 1-1-1, Honjo, ChuoKu, Kumamoto city, Kumamoto Pref.
TEL 096-373-5820
Email saitohide@fc.kuh.kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Kazutaka
Middle name
Last name Oda
Organization Kumamoto University Hospital
Division name Department of Pharmacy
Zip code 860-8556
Address 1-1-1, Honjo, ChuoKu, Kumamoto city, Kumamoto Pref.
TEL 096-373-7457
Homepage URL
Email kazutakaoda-kuh@umin.ac.jp

Sponsor
Institute Kumamoto University Hospital
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kumamoto University Hospital
Address 1-1-1, Honjo, ChuoKu, Kumamoto city, Kumamoto Pref.
Tel 096-373-5657
Email iyg-igaku@jimu.kumamoto-u.ac.jp

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 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Pharmacokinetics for Vancomycin and meropenem have been already analyzed. Vancomycin has been evaluated in a part of cohort population for control of blood concentration. Evaluation for meropenem is on going.
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 No longer recruiting
Date of protocol fixation
2015 Year 02 Month 10 Day
Date of IRB
2015 Year 03 Month 31 Day
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Five blood concentrations are sampled and measured in patients undergoing blood purification therapy around one dosing. Twenty patients are planed to be assembled for population pharmacokinetic analysis using NONMEM method. Subsequently, dose individualization is investigated.

Management information
Registered date
2016 Year 10 Month 06 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028012

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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