A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization

Summary

The purpose of this study is to test if intravenous sulopenem and an oral drug, PF-03709270 are safe and effective in patients that are hospitalized with community acquired pneumonia.

Timeline

Start

2009-01

Primary completion

2009-06

Completion

2009-06

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Sulopenem (Single Intravenous Dose) and PF-03709270 vs Ceftriaxone and Amoxicillin/Clavulanate; Clinical Cure Difference 27.5 (80% CI -4.0 to 55.3) NCT00797108 ↗

registry analysis (superiority or other test); Sulopenem (Multi Intravenous Dose) and PF-03709270 vs Ceftriaxone and Amoxicillin/Clavulanate; Clinical Cure Difference 25.0 (80% CI -13.1 to 57.9) NCT00797108 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ceftriaxone	Other / unclassified	2 g	Intravenous
Subject	Sulopenem	Small molecule	600 mg	Intravenous
Comparator	amoxicillin/clavulanate	Unknown	400 mg	Oral
Subject	sulopenem etzadroxil	Small molecule	1000 mg	Oral

Indications