UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014904 |
|---|---|
| Receipt number | R000017337 |
| Scientific Title | Study on pharmacokinetics and dosage adaptation of meropenem in pediatric patients receiving continuous hemodiafiltration |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2018/09/04 09:10:27 |
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Basic information
Public title
Study on pharmacokinetics and dosage adaptation of meropenem in pediatric patients receiving continuous hemodiafiltration
Acronym
Pharmacokinetic study of meropenem in pediatric patients with CHDF
Scientific Title
Study on pharmacokinetics and dosage adaptation of meropenem in pediatric patients receiving continuous hemodiafiltration
Scientific Title:Acronym
Pharmacokinetic study of meropenem in pediatric patients with CHDF
Region
| Japan |
Condition
Condition
Infectious diseases
Classification by specialty
| Medicine in general | Nephrology | Pediatrics |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, pediatric patients divide two groups; CHDF group and control group, and blood samples are collected. We evaluate the differences of pharmacokinetics and pharmacodynamics of meropenem between two groups.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetic parameters (clearance, volume of distribution, half life) of meropenem
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
| 0 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) 15 years old or younger
2) Patient who is treated with meropenem intravenously
3) Patient who is received continuous haemodiafiltration
4) Informed consent by the document
Key exclusion criteria
1) Other clinical difficulties in this study
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keita Hirai |
Organization
school of pharmaceutical science, university of Shizuoka graduate school
Division name
Department of clinical pharmacology and genetics
Zip code
Address
52-1 Yada Suruga-ku Shizuoka-city Shizuoka Japan
TEL
054-264-5674
hiraik@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keita Hirai |
Organization
school of pharmaceutical science, university of Shizuoka graduate school
Division name
Department of clinical pharmacology and genetics
Zip code
Address
52-1 Yada Suruga-ku Shizuoka-city Shizuoka Japan
TEL
054-264-5674
Homepage URL
hiraik@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
Department of clinical pharmacology and genetics, school of pharmaceutical science, university of Shizuoka graduate school
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shizuoka children's hospital
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
静岡県立こども病院(静岡県)/Shizuoka children's hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | 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
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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | 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
In this study, pediatric patients divide two groups; CHDF group and control group, and blood samples are collected. We evaluate the differences of pharmacokinetics and pharmacodynamics of meropenem between two groups.
Management information
Registered date
| 2014 | Year | 08 | Month | 20 | Day |
Last modified on
| 2018 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017337
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
