CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 47 enrolled
Drug / intervention
ampicillin sodium/sulbactam sodiumdrug
Likely dose
ampicillin sodium/sulbactam sodium 12gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01189487
NCT01189487Phase 3Completed
CompareCT.gov

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

Pfizer·interventional·Posted Aug 26, 2010·Updated Jul 13, 2012

In Brief

A Phase 3 clinical trial evaluating ampicillin sodium/sulbactam sodium for Pneumonia, Bacterial. Completed, enrolled 47 participants across 22 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia, Bacterial
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 26, 2010
Enrollment StartOct 1, 2010
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.8 years ago

Interventions

ampicillin sodium/sulbactam sodiumdrug

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