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Recruitment status Terminated
Unique ID issued by UMIN UMIN000014078
Receipt No. 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

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Basic information
Public title Clinical evaluation of tebipenem pivoxil in the treatment of child community-acquired bacterial pneumonia
Acronym Clinical evaluation of tebipenem pivoxil in the treatment of child community-acquired bacterial pneumonia
Scientific Title Clinical evaluation of tebipenem pivoxil in the treatment of child community-acquired bacterial pneumonia
Scientific Title:Acronym Clinical evaluation of tebipenem pivoxil in the treatment of child community-acquired bacterial pneumonia
Region
Japan

Condition
Condition bacterial pneumonia
Classification by specialty
Infectious disease Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of tebipenem pivoxil against child community-acquired bacterial pneumonia (moderate severity)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical efficacy at the end of treatment
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 tebipenem pivoxil 6mg/kg twice daily orally
Interventions/Control_2 ampicillin 30~40mg/kg three times daily intravenously
or
sulbactam/ampicillin 30~50mg/kg three times daily intravenously
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
6 months-old <=
Age-upper limit
192 months-old >
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuo Sato
Organization Yokohama Rosai Hosipital, Japan Labour Health and Welfare Organization
Division name Department of Pediatrics
Zip code
Address 3211 Kozukue-cho, Kohoku-ku, Yokohama City
TEL 045-474-8111
Email satouatsuo@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Atsuo Sato
Organization Yokohama Rosai Hosipital, Japan Labour Health and Welfare Organization
Division name Department of Pediatrics
Zip code
Address 3211 Kozukue-cho, Kohoku-ku, Yokohama City
TEL 045-474-8111
Homepage URL
Email satouatsuo@mac.com

Sponsor
Institute Yokohama Pediatric Infectious Disease Research Conference
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 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

Other administrative information
Date of disclosure of the study information
2014 Year 06 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 Terminated
Date of protocol fixation
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 27 Day
Last modified on
2018 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.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


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