UMIN-CTR Clinical Trial

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

bacterial pneumonia

Classification by specialty

Infectious disease

Pediatrics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Yokohama Pediatric Infectious Disease Research Conference

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2014

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

05

Month

27

Day

Last modified on

2018

Year

11

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016315