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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003765
Receipt No. 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

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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
Institute Group for Thinking about Wourld-New Oral Carbapenem
Institute
Department

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
URL(English) https://upload.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


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