UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013478 |
|---|---|
| Receipt number | R000015735 |
| Scientific Title | Extended infusion of dripenem for sepsis in hepatopoietic stem cell transplantatation; pharmacokinetic study |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2015/03/23 15:51:05 |
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Basic information
Public title
Extended infusion of dripenem for sepsis in hepatopoietic stem cell transplantatation; pharmacokinetic study
Acronym
Extended infusion of dripenem; pharmacokinetic study
Scientific Title
Extended infusion of dripenem for sepsis in hepatopoietic stem cell transplantatation; pharmacokinetic study
Scientific Title:Acronym
Extended infusion of dripenem; pharmacokinetic study
Region
| Japan |
Condition
Condition
Sepsis in hematopoietic stem cell transplantatation
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Pharmacokinetic evaluation of dripenem(3g/day) in extnded infusion
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
High time above MIC in extnded infusion (4 hour) of dripenem (3g/day)
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Extended infusion (4 hour) of dripenem
Analysis of blood concentration (dripenem)
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. Patient received hematopoietic stem cell transplantatation for hematological malignancy
2. 20-year old or older
3. Patient using central venous catheter
Key exclusion criteria
1. Allergic history of carbapenem or beta-lactam antibiotics
2. Hepatic disorder with grade II or above
3. Renal disorder; less than 70ml/min./1.73m2 (eGFR)
4. Prophylactic antibiotics for bacterial infection except for quinolones
5. Treatment with antifungal drugs
6. Ineligible decision by physician
7. Repeated inclusion of patient
8. Patient without central venous catheter
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Shinohara |
Organization
Graduate school of medicine, The university of Tokyo
Division name
Department of hematology and oncology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3815-5411
sinohaa-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihito Shinohara |
Organization
Graduate school of medicine, The university of Tokyo
Division name
Department of hematology and oncology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3815-5411
Homepage URL
sinohaa-tky@umin.ac.jp
Sponsor or person
Institute
Department of hematology and oncology, graduate school of medicine, The university of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Department of hematology and oncology, graduate school of medicine, The university of Tokyo
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 04 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 07 | 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
| 2014 | Year | 03 | Month | 21 | Day |
Last modified on
| 2015 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015735
