UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012015 |
|---|---|
| Receipt number | R000014042 |
| Scientific Title | Development of TDM-guided treatment with daptomycin based on PK/PD theory by measurement of plasma concentration of daptomycin. |
| Date of disclosure of the study information | 2013/10/21 |
| Last modified on | 2016/04/22 10:54:03 |
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Basic information
Public title
Development of TDM-guided treatment with daptomycin based on PK/PD theory by measurement of plasma concentration of daptomycin.
Acronym
PK/PD of Daptomycin
Scientific Title
Development of TDM-guided treatment with daptomycin based on PK/PD theory by measurement of plasma concentration of daptomycin.
Scientific Title:Acronym
PK/PD of Daptomycin
Region
| Japan |
Condition
Condition
Patients with infection by Methicillin resistant Gram-positive cocci.
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We measure daptomycin plasma concentration by high performance liquid chromatography (HPLC) to establish TDM-guided treatment with daptomycin based on PK/PD theory with more safety and efficacy.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We analyze outcome and side effects of patients treated with daptomycin.
Key secondary outcomes
We analyze relationship between plasma daptomycin concentration trough and creatine phosphokinase.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single-arm open trial of TDM-guided treatment with daptomycin and measurement of plasma daptomycin concentration of patients infected by methicillin resistant Gram-positive cocci.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted in Osaka Medical College Hospital with infection by methicillin resistant gram-positive cocci except for pneumonia with agreement of this study.
Key exclusion criteria
Nothing
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Ukimura |
Organization
Osaka Medical College Hospital
Division name
Infection Control Team
Zip code
Address
2-7 Daigakumachi Takatsuki-city, Osaka
TEL
072-683-1221
in3011@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Ukimura |
Organization
Osaka Medical College Hospital
Division name
Infection Control Team
Zip code
Address
2-7 Daigakumachi Takatsuki-city, Osaka
TEL
072-683-1221
Homepage URL
http://hospital.osaka-med.ac.jp/about/dept_list/related_section/kansen_rinsyou.html
in3011@poh.osaka-med.ac.jp
Sponsor or person
Institute
Infection control team of Osaka Medical College Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of General Internal Medicine, Osaka Medical College
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
大阪医科大学附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 21 | 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
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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 10 | Day |
Last modified on
| 2016 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014042
