UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043201 |
|---|---|
| Receipt number | R000049303 |
| Scientific Title | Population Pharmacokinetics and Evaluation dosing of Ceftolozane-Tazobactam in Critically ill Patients |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2023/12/21 11:07:01 |
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Basic information
Public title
Population Pharmacokinetics and Evaluation dosing of Ceftolozane-Tazobactam in Critically ill Patients
Acronym
Population Pharmacokinetics and Evaluation dosing of Ceftolozane-Tazobactam in Critically ill Patients
Scientific Title
Population Pharmacokinetics and Evaluation dosing of Ceftolozane-Tazobactam in Critically ill Patients
Scientific Title:Acronym
Population Pharmacokinetics and Evaluation dosing of Ceftolozane-Tazobactam in Critically ill Patients
Region
| Japan |
Condition
Condition
Acute kidney disease due to sepsis
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of pharmacokinetics of ceftolozan-tazobactam and dose design in patients with acute kidney injury due to sepsis
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of ceftolozan-tazobactam pharmacokinetics by renal function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Sampling of patient blood and sulfate of continuous renal r eplacement therapy
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) Inpatients administered ceftolozan-tazobactam in the ICU
2) Patients over 20 years old
3) Patients whose written consent has been obtained by the patient or his / her substitute
Key exclusion criteria
1) Patients with a history of anaphylaxis-like symptoms due to ceftolozan tazobactam
2) Patients diagnosed as pregnant at the time of consent
3) Patients who participate in or participate in other evaluations
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Nishi |
Organization
Hyogo College of Medicine
Division name
Intensive Care Unit
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya-city, Hyogo, Japan
TEL
0798-45-6389
tide7977@gmail.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ide |
Organization
Hyogo College of Medicine
Division name
Intensive Care Unit
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya-city, Hyogo, Japan
TEL
0798-45-6389
Homepage URL
tide7977@gmail.com
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College 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
Hyogo College of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya-city, Hyogo, Japan
Tel
0798-45-6066
rinri@hyo-med.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
| 2021 | Year | 02 | 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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2023 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049303
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
