UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the clinical efficacy and number of days of tebipenem pivoxil administration for the treatment of pediatric bacterial pneumonia.
Title of the study (Brief title)	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	Kazunobu Ouchi
Organization	Kawasaki Medical School
Division name	Department of Pediatrics
Address	577, Matsushima, Kurashiki-shi, Okayama
TEL	086-462-1111
Email

Public contact
Name of contact person	Hiroto Akaike
Organization	Kawasaki Medical School
Division name	Department of Pediatrics
Address	577, Matsushima, Kurashiki-shi, Okayama
TEL	086-462-1111
Homepage URL
Email

Sponsor
Institute	Department of Pediatrics, Kawasaki Medical School
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011829