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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Community Acquired Pneumonia (CAP)

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00809328

A0661191

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

Azithromycin

Experimental group

Description:

Azithromycin switch therapy (switch from intravenous to oral)

Treatment:

Drug: Azithromycin