UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035236 |
|---|---|
| Receipt number | R000040143 |
| Scientific Title | Study on interindividual variability in daptomycin pharmacokinetics and pharmacodynamics in patients with MRSA |
| Date of disclosure of the study information | 2018/12/15 |
| Last modified on | 2018/12/13 01:07:32 |
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Basic information
Public title
Study on interindividual variability in daptomycin pharmacokinetics and pharmacodynamics in patients with MRSA
Acronym
Daptomycin PK-PD in patients with MRSA
Scientific Title
Study on interindividual variability in daptomycin pharmacokinetics and pharmacodynamics in patients with MRSA
Scientific Title:Acronym
Daptomycin PK-PD in patients with MRSA
Region
| Japan |
Condition
Condition
infectious disease
Classification by specialty
| Medicine in general | Infectious disease | Surgery in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to explore a factor affecting the interindividual variability in clinical responses to daptomycin.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The plasma concentrations of total and free daptomycin at 72 hours or later after initiation of daptomycin therapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients treated with daptomycin for infectious diseases
2. Patients from whom written informed consent was obtained
Key exclusion criteria
1. Patients discontinued the treatment of daptomycin
2. Patients assessed as inappropriate for the study enrollment by the attending physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Kawakami |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital pharmacy
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL
053-435-2763
pharmacyham-adm@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Naitou |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital pharmacy
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL
053-435-2763
Homepage URL
naitou@hama-med.ac.jp
Sponsor or person
Institute
Department of Hospital pharmacy, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Hospital pharmacy, Hamamatsu University School of Medicine
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
| 2018 | Year | 12 | Month | 15 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The concentrations of total and free daptomycin are measured for pharmacokinetic analysis. Clinical laboratory values such as serum total protein, serum albumin, total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, blood urea nitrogen, serum creatinine, C-reactive protein, white blood cell count, and creatine kinase were observed for evaluation of clinical response during this study.
Management information
Registered date
| 2018 | Year | 12 | Month | 13 | Day |
Last modified on
| 2018 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040143
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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