Clinical evaluation of efficacy and safety 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009208

Enrollment

Registered

2012-10-29

Start date

2012-10-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

community acquired bacterial pneumonia and mycoplasma pneumonia

Interventions

CLARITH Tablets 200mg(800mg/day)

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, H.influenzae or M.pneumoniae otherwise patients suspected to be bacterial pneumonia or Mycoplasma pneumonia 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

Contacts

Public ContactDaisuke Fukuta

Organization of Clinical Trials for Respiratory and Infectious Disease secretariat

fukuta@calo.co.jp086-805-8722

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026