UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010144 |
|---|---|
| Receipt number | R000011829 |
| Scientific Title | Study of the clinical efficacy and number of days of tebipenem pivoxil administration for the treatment of pediatric bacterial pneumonia. |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2017/05/22 17:33:36 |
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Basic information
Public title
Study of the clinical efficacy and number of days of tebipenem pivoxil administration for the treatment of pediatric bacterial pneumonia.
Acronym
Clinical efficacy of tebiepenem pivoxil for the treatment of childhood pneumonia.
Scientific Title
Study of the clinical efficacy and number of days of tebipenem pivoxil administration for the treatment of pediatric bacterial pneumonia.
Scientific Title:Acronym
Clinical efficacy of tebiepenem pivoxil for the treatment of childhood pneumonia.
Region
| Japan |
Condition
Condition
Pediatric bacterial pneumonia
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the clinical efficacy of TBPM-PI at a dose of 6 mg/kg twice daily in principle for 3 days (up to 7 days) in patients who are candidates for in-hospital treatment as well as candidates for outpatient treatment but who are suspected of being infected with resistant bacteria.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
* Clinical effect 1 week after the end of treatment (i.e., determination of healing).
* Adverse events occurring during the assessment period (with undeniable causality: side effects).
Key secondary outcomes
* Bacteriological efficacy at the end of treatment (day 3 to day 8).
* Clinical efficacy 2 to 3 days after the initiation of treatment (day 3 to day 4) and at the end of treatment (day 3 to day 8).
* Changes in body temperature and laboratory values.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 0 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Outpatients and hospitalized patients are eligible.
2) All of the following conditions must be met:
(1) Seven days or less after disease onset.
(2) Presence of symptoms of respiratory infection, such as fever (over 37.5 degrees centigrade), cough, and expectorated sputum.
(3) Images of new infiltration visible on the chest radiograph.
(4) WBC count over 15,000/uL or CRP level over 4 mg/dL.
3) Pediatric patients with a moderate or mild form of the disease or with a risk of being infected by resistant bacteria according to the standard criteria described in the 2011 guidelines.
Key exclusion criteria
1) Pediatric patients with other infectious foci who are potentially unresponsive to treatment with orally administered medication.
2) Pediatric patients in whom the efficacy and safety of the study drug is difficult to determine because of a progressive, complicated, or severe underlying disease believed to critically influence the onset of the infection, its clinical course, and therapeutic efficacy.
3) Pediatric patients with convulsive disorders, such as epilepsy, as an underlying disease.
4) Pediatric patients with a lipid metabolism disorder or congenital carnitine deficiency.
5) Pediatric patients with severe hepatic or renal dysfunction.
To determine whether the pediatric patient is appropriate for this study, the attending physician must judge the child's condition on the basis of the following laboratory values:
- Liver function values: AST (GOT) levels over 100 IU/L or ALT (GPT) levels over 100 IU/L.
- Renal function values: BUN over 25 mg/dL or serum creatinine levels over 2.0 mg/dL.
6) Pediatric patients with poor oral ingestion or receiving parenteral feeding.
7) Pediatric patients with a history of allergy to beta-lactam antibiotics (e.g.,carbapenems, penicillin, and cephem).
8) Pediatric patients who have received other antibiotics and exhibited improvements.
9) Pediatric patients deemed inappropriate for this study by the attending physician.
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-shi, Okayama
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroto Akaike |
Organization
Kawasaki Medical School
Division name
Department of Pediatrics
Zip code
Address
577, Matsushima, Kurashiki-shi, Okayama
TEL
086-462-1111
Homepage URL
Sponsor or person
Institute
Department of Pediatrics, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Keio University School of Medicine
Niigata University Medical and Dental Hospital
Osaka Rosai Hospital
Sotobo Children's Clinic, Medical Corporation Shigyo-no-kai
Kurosaki Children's Clinic
etc
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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（岡山県）
新潟大学（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）
国立病院機構東京医療センター（東京都）
旭川厚生病院（北海道）
富士重工業健康保険組合 太田記念病院（群馬県）
博慈会記念総合病院（東京都）
久留米大学医学部（福岡県）
長井小児科医院（福岡県）
いけざわこどもクリニック（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）
県立広島病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
National Hospital Organization Tokyo Medical Center
Asahikawa Kosei Hospital
Fuji Heavy Industries Ltd., Health Insurance Society General Ota Hospital
Hakujikai Memorial Hospital
Kurume University School of Medicine
Yokohama Minami Kyosai Hospital
Yokosuka Kyosai Hospital
Prefectural University of Hiroshima
Management information
Registered date
| 2013 | Year | 03 | Month | 01 | Day |
Last modified on
| 2017 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011829
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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