Unique ID issued by UMIN | UMIN000014078 |
---|---|
Receipt number | R000016315 |
Scientific Title | Clinical evaluation of tebipenem pivoxil in the treatment of child community-acquired bacterial pneumonia |
Date of disclosure of the study information | 2014/06/01 |
Last modified on | 2018/11/29 18:20:53 |
Clinical evaluation of tebipenem pivoxil in the treatment of child community-acquired bacterial pneumonia
Clinical evaluation of tebipenem pivoxil in the treatment of child community-acquired bacterial pneumonia
Clinical evaluation of tebipenem pivoxil in the treatment of child community-acquired bacterial pneumonia
Clinical evaluation of tebipenem pivoxil in the treatment of child community-acquired bacterial pneumonia
Japan |
bacterial pneumonia
Infectious disease | Pediatrics |
Others
NO
To evaluate efficacy and safety of tebipenem pivoxil against child community-acquired bacterial pneumonia (moderate severity)
Efficacy
Clinical efficacy at the end of treatment
1)Time to defervescence after the first administration
2)Recrudescence of pneumonia within 1 week after the end of treatment
3)Adverse events during treatment
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
tebipenem pivoxil 6mg/kg twice daily orally
ampicillin 30~40mg/kg three times daily intravenously
or
sulbactam/ampicillin 30~50mg/kg three times daily intravenously
6 | months-old | <= |
192 | months-old | > |
Male and Female
1)Hospitalized patients who are diagnosed as community-acquired bacterial pneumonia are eligible.
2) Both of the following conditions must be met:
- WBC count over 12,000/uL or CRP level over 2 mg/dL.
- Patients with a moderate form of the disease according to the standard criteria described in the 2011 guidelines.
1)Patients with other infectious foci who are potentially unresponsive to treatment with orally administered medication.
2)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)Patients with convulsive disorders, such as epilepsy, as an underlying disease.
4)Patients with a lipid metabolism disorder or congenital carnitine deficiency.
5)Patients with a history of allergy to beta-lactam antibiotics (e.g.,carbapenems, penicillin, and cephem).
6)Patients in whom tebipenem pivoxil is contraindicated.
7)Patients who have received pivalate-conjugated antibiotics more than 1 week within 2 weeks before admission.
8)Patients who have received tebipenem pivoxil or control antibiotics just before admission.
9)Patients who have received other antibiotics and exhibited improvements.
10)Patients who are presenting with concurrent asthma attack.
11)Patients who are definitively diagnosed as Mycoplasmal pneumonia or Chlamydial penumina
12)Patients deemed inappropriate for this study by the attending physician.
200
1st name | |
Middle name | |
Last name | Atsuo Sato |
Yokohama Rosai Hosipital, Japan Labour Health and Welfare Organization
Department of Pediatrics
3211 Kozukue-cho, Kohoku-ku, Yokohama City
045-474-8111
satouatsuo@mac.com
1st name | |
Middle name | |
Last name | Atsuo Sato |
Yokohama Rosai Hosipital, Japan Labour Health and Welfare Organization
Department of Pediatrics
3211 Kozukue-cho, Kohoku-ku, Yokohama City
045-474-8111
satouatsuo@mac.com
Yokohama Pediatric Infectious Disease Research Conference
None
Self funding
NO
労働者健康福祉機構横浜労災病院、横浜市立みなと赤十字病院、横浜市立大学附属市民総合医療センター
2014 | Year | 06 | Month | 01 | Day |
Unpublished
Terminated
2014 | Year | 06 | Month | 01 | Day |
2014 | Year | 06 | Month | 02 | Day |
2014 | Year | 05 | Month | 27 | Day |
2018 | Year | 11 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016315
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |