Investigation of the efficacy and safety of high-dose clarithromycin in adult patients with community-acquired pneumonia-multicenter,single-group,open-label study

Investigation of the efficacy and safety of high-dose clarithromycin in adult patients with community-acquired pneumonia-multicenter,single-group,open-label study - Investigation of the efficacy and safety of high-dose clarithromycin in adult patients with community-acquired pneumonia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016277

Enrollment

Registered

2015-01-20

Start date

2015-01-20

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

Adult community-acquired pneumonia

Interventions

Clarithromycin is orally administered at a daily dosage of 800 mg in two divided doses. The administration period is between 4 and 14 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with mild or moderate community-acquired pneumonia in accordance with the JRS guidelines for severity (2) The patient's pneumonia is suspected to be caused by either pneumococcus, Hemophilus influenza or Mycoplasma pneumonia, or is either suspected bacterial pneumonia or mycoplasma pneumonia in accordance with the JRS guidelines. (3) Patients who can visit the hospital (4) Patients who can provide informed consent in writing

Exclusion criteria

Exclusion criteria: Patients who have previously experienced anaphylaxis reactions to the investigational drug or other drugs (2) Patients who are treated with pimozide- or ergotamine-containing drugs or tadalafil (3) Patients determined to be ineligible for the study due to liver disease, kidney disease, heart disease or other serious complications (4) Pregnant or lactating females and females who are suspected of being pregnant (5) Patients assessed by the principal investigator or sub-investigator as

Design outcomes

Primary

Measure	Time frame
Based on clinical findings from observations and laboratory tests, the clinical efficacy of the investigational drug will be determined at the completion or discontinuation of treatment, in accordance with the guidelines for assessment of effectiveness of pneumonia treatment established by the Japanese Society of Chemotherapy. All adverse events during the treatment period (from the start of treatment with investigational drug until the completion or discontinuation of treatment with investigational drug) will be investigated.	—

Measure

Time frame

Based on clinical findings from observations and laboratory tests, the clinical efficacy of the investigational drug will be determined at the completion or discontinuation of treatment, in accordance with the guidelines for assessment of effectiveness of pneumonia treatment established by the Japanese Society of Chemotherapy. All adverse events during the treatment period (from the start of treatment with investigational drug until the completion or discontinuation of treatment with investigational drug) will be investigated.

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Countries

Japan

Contacts

Public ContactCommunity-acquired pneumonia study secretariat

Satt Co., Ltd. Clinical Research Group

pneumonia@sa-tt.co.jp03-5312-5026

Outcome results

None listed

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