UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002149 |
|---|---|
| Receipt number | 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 11:55:00 |
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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
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
imanakah@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Emergency and Critical Care Medicine, the University of Tokushima graduate school
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002602
