UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003765
Receipt number R000004438
Scientific Title clinical evaluation on effectiveness and safety of orapenem pediatiric granule for children with bacterial pneumonia
Date of disclosure of the study information 2011/04/30
Last modified on 2018/09/12 18:19:16

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Basic information

Public title

clinical evaluation on effectiveness and safety of orapenem pediatiric granule for children with bacterial pneumonia

Acronym

KP2

Scientific Title

clinical evaluation on effectiveness and safety of orapenem pediatiric granule for children with bacterial pneumonia

Scientific Title:Acronym

KP2

Region

Japan


Condition

Condition

bacterial penumonia in children

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness and efficacy of orapenem pediatric granule for children with bacterial pneumoniae

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

effectiveness of orapenem pediatric granule

Key secondary outcomes

safety of orapenem pediatric granule


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

orapenem pediatric granule

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

2 months-old <=

Age-upper limit

192 months-old >

Gender

Male and Female

Key inclusion criteria

mild to severe bacterial pneumonia by severity classification of guidelines for the management of respiratory infectious diseases in children in Japan 2007

Key exclusion criteria

children who refuse or are unable to take medicine
children with severe infection who must be treated with parenteral antibiotics

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunobu Ouchi

Organization

Kawasaki Medical School

Division name

Department of Pediatrics

Zip code


Address

577 Matsushima, Kurashiki, Okayama

TEL

086-462-1111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazunobu Ouchi

Organization

Kawasaki Medical School

Division name

Department of Pediatrics

Zip code


Address

577 Matsushima, Kurashiki, Okayama

TEL

086-462-1111

Homepage URL


Email

pediatr@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Group for Thinking about Wourld-New Oral Carbapenem

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

慶応義塾大学(東京都)、新潟県立新発田病院(新潟県)、大阪労災病院(大阪府)、外房こどもクリニック(千葉県)、くろさきこどもクリニック(千葉県)、東京医療センター(東京都)、旭川厚生病院(北海道)、太田病院(群馬県)、博慈会記念総合病院(東京都)、久留米大学(福岡県)、横浜南共済病院(神奈川県)、横須賀共済病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Target sample size:100case
Sample size:22
clinical effective response 22/22 100%
side effect 2/22 9% (only dearrhea)

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

2010 Year 05 Month 25 Day

Date of IRB


Anticipated trial start date

2010 Year 06 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry

2012 Year 03 Month 01 Day

Date trial data considered complete

2012 Year 06 Month 01 Day

Date analysis concluded

2012 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 06 Month 16 Day

Last modified on

2018 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004438


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name