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Recruitment status
Unique ID issued by UMIN UMIN000002149
Receipt No. R000002602
Scientific Title A loading dose of teicoplanin in critically ill patients: effectiveness of dosing determined by data analysis software.
Date of disclosure of the study information 2009/08/01
Last modified on 2012/05/23

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Basic information
Public title A loading dose of teicoplanin in critically ill patients: effectiveness of dosing determined by data analysis software.
Acronym A loading dose of teicoplanin with data analysis software.
Scientific Title A loading dose of teicoplanin in critically ill patients: effectiveness of dosing determined by data analysis software.
Scientific Title:Acronym A loading dose of teicoplanin with data analysis software.
Region
Japan

Condition
Condition Gram-positive infections
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine if the software predict trough concentration of teicoplanin accurately, and if the concentration increase more quickly than conventional method.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes trough concentration of teicoplanin at 24, 48, 72hrs after first administration.
Key secondary outcomes The duration of ICU stay and mortality rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 initial loading dose of teicoplanin is determined by a data analysis software
Interventions/Control_2 400 mg of teicoplanin is administered for loading dose every 12 h three times and following 24 h.
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

Not applicable
Gender Male and Female
Key inclusion criteria diagnosed or suspected of Gram-positive infections in our intensive care unit
Key exclusion criteria hemodialysis therapy, infective endocarditis and purulent osteomyelitis.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaji Nishimura
Organization Tokushima University Hospital
Division name Emergency and Critical Care Medicine
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima, 770-8503 Japan
TEL 0886339347
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Imanaka
Organization Tokushima University Hospital
Division name Emergency and Critical Care Medicine
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima, 770-8503 Japan
TEL 0886339347
Homepage URL
Email imanakah@clin.med.tokushima-u.ac.jp

Sponsor
Institute Emergency and Critical Care Medicine, the University of Tokushima graduate school
Institute
Department

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
21st annual congress, European society of intensive care medicine
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
Date of protocol fixation
2007 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 01 Month 01 Day
Date trial data considered complete
2010 Year 01 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 30 Day
Last modified on
2012 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002602

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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