The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)

Pfizer

Status and phase

Completed

Phase 3

Conditions

Pneumonia, Bacterial

Treatments

Drug: ampicillin sodium/sulbactam sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT01189487

A9231001

Details and patient eligibility

About

Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.

Enrollment

47 patients

Sex

All

Ages

16 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

16 years of age or older.
Patients who were diagnosed as moderate to severe community acquired pneumonia requiring initial intravenous therapy and hospitalization.

Exclusion criteria

Known or suspected hypersensitivity or intolerance to ampicillin sodium/sulbactam sodium, other penicillins, or cephems.
Hepatic dysfunction [Aspartate Aminotransferase(AST), Alanine Aminotransferase (ALT), total bilirubin > 3 times upper limit of normal range values].
Severe renal dysfunction (creatinine clearance < 30 ml/min).
Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.