UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009504
Receipt number R000011117
Scientific Title A clinical comparative study of SBT/ABPC and TAZ/PIPC in patients with community-acquired pneumonia
Date of disclosure of the study information 2012/12/10
Last modified on 2015/06/09 11:42:46

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A clinical comparative study of SBT/ABPC and TAZ/PIPC in patients with community-acquired pneumonia

Acronym

Clinical comparative study of SBT/ABPC and TAZ/PIPC

Scientific Title

A clinical comparative study of SBT/ABPC and TAZ/PIPC in patients with community-acquired pneumonia

Scientific Title:Acronym

Clinical comparative study of SBT/ABPC and TAZ/PIPC

Region

Japan


Condition

Condition

community-acquired pneumonia

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of the clinical effect of SBT/ABPC and TAZ/PIPC in community-acquired pneumonia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

clinical usefulness

Key secondary outcomes

Nothing


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

group of SBT/ABPC
to 2015, March 31

Interventions/Control_2

group of TAZ/PIPC
to 2015, March 31

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

community-acquired pneumonia

Key exclusion criteria

hospital-acquired pneumonia

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Niro Okimoto

Organization

Kawasaki Medical School

Division name

General Internal Medicine 1

Zip code


Address

2-1-80, Nakasange, Kitaku, Okayama City, Japan

TEL

086-225-2111

Email

n.okimoto@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Niro Okimoto

Organization

Kawasaki Medical School

Division name

General Internal Medicine 1

Zip code


Address

2-1-80, Nakasange, Kitaku, Okayama City, Japan yama city

TEL

086-225-2111

Homepage URL


Email

n.okimoto@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

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

川崎医科大学附属川崎病院(岡山県)


Other administrative information

Date of disclosure of the study information

2012 Year 12 Month 10 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

Terminated

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

2012 Year 12 Month 10 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 10 Day

Last follow-up date


Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 12 Month 08 Day

Last modified on

2015 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011117


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name