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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013478
Receipt No. 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

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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
Email 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
Email sinohaa-tky@umin.ac.jp

Sponsor
Institute Department of hematology and oncology, graduate school of medicine, The university of Tokyo
Institute
Department

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
Email

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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015735

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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