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

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 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


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

Value
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