NCT01189487

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

A Multicenter, Unblinded, Non-Comparative Study Of Unasyn-S 12 G/Day Evaluating The Safety And Efficacy In Japanese Adult Subjects With Community Acquired Pneumonia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 16 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pneumonia, Bacterial

Interventions

Type	Name	Description
DRUG	ampicillin sodium/sulbactam sodium	ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-08-26
• Last updated: 2012-07-13
• Results posted: 2012-05-18

Locations

22 sites across 1 country: Japan