Conditions: Pneumonia, Bacterial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 35
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Loading dose of IV sulopenem with switch to oral PF-03709270 arm 2: IV sulopenem with switch to oral PF-03709270 arm 3: IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator

Interventions: intervention 1: sulopenem and PF-03709270 intervention 2: Sulopenem and PF-03709270 intervention 3: Ceftriaxone and amoxicillin/clavulanate
Intervention descriptions: intervention 1: Sulopenem - 600 mg infused over 1 hour, single loading dose and switch to oral PF-03709270 - 1000 mg twice a day intervention 2: Sulopenem - 600 mg infused over 1 hour twice daily for a minimum of 2 days and switch to oral PF-03709270 - 1000 mg twice a day intervention 3: IV ceftriaxone (2g) infused over 30 minutes QD (once daily) for minimum of 2 days Step down oral amoxicillin/clavulanate potassium suspension (400 mg/5 ml) BID (every 12 hours)

Protocol document: