Clinical evaluation of efficacy and safety of CLARITH Tablets 200 mg (800mg/day) against community acquired bacterial pneumonia.
- Conditions
- community acquired bacterial pneumonia
- Registration Number
- JPRN-UMIN000004745
- Lead Sponsor
- Organization of Clinical Trials for Respiratory and Infectious Disease
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Efficacy: A bacterial response will be evaluated at the end of the medication or at the end of observation period.