UMIN-CTR Clinical Trial

Public title

Clinical evaluation of efficacy and safety of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia.

Acronym

Clinical evaluation of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia.

Scientific Title

Clinical evaluation of efficacy and safety of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia.

Scientific Title:Acronym

Clinical evaluation of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia.

Region

Japan

Condition

community acquired bacterial pneumonia

Classification by specialty

Pneumology

Infectious disease

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to evaluate the clinical efficacy and safety of CLARITH Tablets 200 mg (800mg/day) administration for the subjects with community acquired bacterial pneumonia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Efficacy:
A clinical response will be evaluated by an attending physician at the end of the medication or at the end of observation period.
Safety:
An adverse event will be recorded until the end of medication.

Key secondary outcomes

Efficacy:
A bacterial response will be evaluated at the end of the medication or at the end of observation period.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

CLARITH Tablets 200 (800mg/day)

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Subject of this study are patients who fulfill all following criteria and need this drug treatment.
1)Patients whose JRS severity classification are mild to moderate.
2)Patients who can treat out of hospital refer to JRS guideline.
3)Patients whose presumable pathogenic bacteria is S.pneumoniae or H.influenzae otherwise patients suspected to be bacterial pneumonia refer to JRS guideline by physician in charge.

Key exclusion criteria

1)Patients with known hypersensitivity to clarithromycin or any other component of the product.
2)Patients receiving treatment with pimozide, ergotamine(or its derivatives), or tadalafil/ADCIRCA.
3)Patients under 20 years old.
4)Patients with hypersensitivity to any other antibiotics.
5)Patients with hepatic dysfunction, renal impairment, cardiac disorder, or other severe complication which inadequate this study.
6)Women known pregnant, lactation or suspected to be pregnant.
7)Patients who are regarded as inadequate subject by physician in charge (*)
*Posible to enter the patients who treat low-dose long-time macrolides therapy(200mg) when increase the dosage(800mg).
*Posible to enter the patients who previously treat 400mg of clarithromycin if increase the dosage(800mg).

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Yoshihito Niki

Organization

School of Medicine, Showa University

Division name

Clinical Infectious Disease

Zip code

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

School of Medicine, Showa University

Division name

Clinical Infectious Disease

Zip code

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan

TEL

Homepage URL

Email

Institute

Organization of Clinical Trials
for Respiratory and Infectious Disease

Institute

Department

Personal name

Organization

Organization of Clinical Trials
for Respiratory and Infectious Disease

Organization

Division

Category of Funding Organization

Non profit foundation

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

Date of disclosure of the study information

2010

Year

12

Month

17

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

Completed

Date of protocol fixation

2010

Year

11

Month

13

Day

Date of IRB

Anticipated trial start date

2010

Year

12

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

12

Month

17

Day

Last modified on

2012

Year

10

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005650