UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050335 |
|---|---|
| Receipt number | R000057023 |
| Scientific Title | Development of Tazobactam/Piperacillin Optimal Individualized Dose and Route for Maximize the Effects in Empiric Therapy. |
| Date of disclosure of the study information | 2023/02/14 |
| Last modified on | 2023/09/14 10:45:31 |
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Basic information
Public title
Development of Tazobactam/Piperacillin Optimal Individualized Dose and Route for Maximize the Effects in Empiric Therapy.
Acronym
Development of Tazobactam/Piperacillin Optimal Individualized Dose and Route for Maximize the Effects in Empiric Therapy.
Scientific Title
Development of Tazobactam/Piperacillin Optimal Individualized Dose and Route for Maximize the Effects in Empiric Therapy.
Scientific Title:Acronym
Development of Tazobactam/Piperacillin Optimal Individualized Dose and Route for Maximize the Effects in Empiric Therapy.
Region
| Japan |
Condition
Condition
One or more of the following infections: sepsis, pneumonia, peritonitis, intra-abdominal abscess, cholecystitis, and cholangitis
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze the population pharmacokinetics of tazobactam and piperacillin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measure blood levels by blood draw 3-5 days after starting tazobactam/piperacillin.
Blood sampling points are 3 points: trough concentration, concentrations 1 and 2 hours after the end of infusion. (5mL each)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have provided written informed consent of their own free will
Key exclusion criteria
Patients on dialysis
Patients scheduled for less than 3 days of treatment with Tazobactam/Piperacillin
Other patients deemed inappropriate by the attending physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Kawaguchi |
Organization
Yamaguchi University Hospital
Division name
Department of Pharmacy
Zip code
755-8505
Address
Minamikogushi, Ube-shi, Yamaguchi
TEL
0836-22-2669
y.kawa@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Kawaguchi |
Organization
Yamaguchi University Hospital
Division name
Department of Pharmacy
Zip code
755-8505
Address
Minamikogushi, Ube-shi, Yamaguchi
TEL
0836-22-2669
Homepage URL
y.kawa@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamaguchi University Hospital
Address
Minamikogushi, Ube-shi, Yamaguchi
Tel
0836-22-2669
y.kawa@yamaguchi-u.ac.jp
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
| 2023 | Year | 02 | Month | 14 | 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
8
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
| 2022 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measure blood levels by blood draw 3-5 days after starting tazobactam/piperacillin.
Blood sampling points are 3 points: trough concentration, concentrations 1 and 2 hours after the end of infusion. (5mL each)
Management information
Registered date
| 2023 | Year | 02 | Month | 14 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057023
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
