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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Pneumonia, Bacterial

Treatments: Drug: sulopenem and PF-03709270; Drug: Ceftriaxone and amoxicillin/clavulanate; Drug: Sulopenem and PF-03709270

Study type: Interventional

Funder types: Industry

Identifiers

NCT00797108

A8811020

2008-006307-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalized male or female patients 18 years of age or older.
• Female patients of childbearing potential must not be pregnant.
• Must exhibit at least two pre-specified clinical symptoms/signs of pneumonia.
• Must require hospitalization for the pneumonia.
• Chest Xray must be suggestive of a pneumonia.

Exclusion criteria

• Hospital or ventilator associated pneumonia.
• Patients with cystic fibrosis, pneumocystis carinii pneumonia or active tuberculosis.
• Previous treatment for the current pneumonia episode received for more than 24 hours.
• Allergies to penems or beta lactams.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 3 patient groups

1

Experimental group

Description:

Loading dose of IV sulopenem with switch to oral PF-03709270

Treatment:

Drug: sulopenem and PF-03709270

2

Experimental group

Description:

IV sulopenem with switch to oral PF-03709270

Treatment:

Drug: Sulopenem and PF-03709270

3

Active Comparator group

Description:

IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator

Treatment:

Drug: Ceftriaxone and amoxicillin/clavulanate