Unique ID issued by UMIN | UMIN000009208 |
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Receipt number | R000010797 |
Scientific Title | Clinical evaluation of efficacy and safety of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia and mycoplasma pneumonia. |
Date of disclosure of the study information | 2012/10/29 |
Last modified on | 2013/11/26 09:29:27 |
Clinical evaluation of efficacy and safety of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia and mycoplasma pneumonia.
Clinical evaluation of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia and mycoplasma pneumonia.
Clinical evaluation of efficacy and safety of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia and mycoplasma pneumonia.
Clinical evaluation of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia and mycoplasma pneumonia.
Japan |
community acquired bacterial pneumonia and mycoplasma pneumonia
Pneumology | Infectious disease |
Others
NO
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 and mycoplasma pneumonia.
Safety,Efficacy
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.
Efficacy:
A bacterial response will be evaluated at the end of the medication or at the end of observation period.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
CLARITH Tablets 200mg(800mg/day)
20 | years-old | <= |
Not applicable |
Male and Female
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, H.influenzae or M.pneumoniae otherwise patients suspected to be bacterial pneumonia or Mycoplasma pneumonia by physician in charge.
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).
24
1st name | |
Middle name | |
Last name | Yoshihito Niki |
School of Medicine, Showa University
Clinical Infectious Disease
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
1st name | |
Middle name | |
Last name | Daisuke Fukuta |
Organization of Clinical Trials for Respiratory and Infectious Disease
secretariat
23-16-2 Kaminakano, Kita-ku, Okayama-shi, Okayama 700-0972, Japan
086-805-8722
fukuta@calo.co.jp
Organization of Clinical Trials
for Respiratory and Infectious Disease
Organization of Clinical Trials
for Respiratory and Infectious Disease
Non profit foundation
NO
2012 | Year | 10 | Month | 29 | Day |
Unpublished
Completed
2012 | Year | 09 | Month | 28 | Day |
2012 | Year | 10 | Month | 26 | Day |
2013 | Year | 03 | Month | 31 | Day |
2012 | Year | 10 | Month | 29 | Day |
2013 | Year | 11 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010797
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