community acquired bacterial pneumonia
Conditions
Interventions
CLARITH Tablets 200 (800mg/day)
Sponsors
Organization of Clinical Trials for Respiratory and Infectious Disease
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Efficacy: A bacterial response will be evaluated at the end of the medication or at the end of observation period. | — |
Countries
Japan
Outcome results
None listed