Overview

The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)

Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
0
Participant gender:
All
Summary
Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Azithromycin
Criteria
Inclusion Criteria:

- 16 years of age or older patients with CAP.

- Patients who were diagnosed as moderate in severity.

Exclusion Criteria:

- Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides,
or ketolides.

- Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).

- Severe renal dysfunction (creatinine clearance < 30 ml/min).

- Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients
who have a congenital or sporadic long QT syndrome, or who are received the drugs with
reported QT prolongation.

- Severe underlying disease.