Unique ID issued by UMIN | UMIN000003765 |
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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 |
clinical evaluation on effectiveness and safety of orapenem pediatiric granule for children with bacterial pneumonia
KP2
clinical evaluation on effectiveness and safety of orapenem pediatiric granule for children with bacterial pneumonia
KP2
Japan |
bacterial penumonia in children
Pediatrics |
Others
NO
To evaluate the effectiveness and efficacy of orapenem pediatric granule for children with bacterial pneumoniae
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
effectiveness of orapenem pediatric granule
safety of orapenem pediatric granule
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
orapenem pediatric granule
2 | months-old | <= |
192 | months-old | > |
Male and Female
mild to severe bacterial pneumonia by severity classification of guidelines for the management of respiratory infectious diseases in children in Japan 2007
children who refuse or are unable to take medicine
children with severe infection who must be treated with parenteral antibiotics
100
1st name | |
Middle name | |
Last name | Kazunobu Ouchi |
Kawasaki Medical School
Department of Pediatrics
577 Matsushima, Kurashiki, Okayama
086-462-1111
1st name | |
Middle name | |
Last name | Kazunobu Ouchi |
Kawasaki Medical School
Department of Pediatrics
577 Matsushima, Kurashiki, Okayama
086-462-1111
pediatr@med.kawasaki-m.ac.jp
Group for Thinking about Wourld-New Oral Carbapenem
Kawasaki Medical School
Other
Japan
NO
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)
2011 | Year | 04 | Month | 30 | Day |
Published
Target sample size:100case
Sample size:22
clinical effective response 22/22 100%
side effect 2/22 9% (only dearrhea)
Completed
2010 | Year | 05 | Month | 25 | Day |
2010 | Year | 06 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 09 | Month | 01 | Day |
2010 | Year | 06 | Month | 16 | Day |
2018 | Year | 09 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004438
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