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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia, Bacterial

Intervention: sulopenem and PF-03709270 (Drug); Sulopenem and PF-03709270 (Drug); Ceftriaxone and amoxicillin/clavulanate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

Official title: A Phase 2 Randomized, Double-Blind, Double-Dummy Efficacy, Safety And Tolerability Study Of Iv Sulopenem With Switch To Oral PF-03709270 Compared To Ceftriaxone With Step Down To Amoxicillin/Clavulanate Potassium (Augmentin) In Subjects With Community Acquired Pneumonia (Cap) Requiring Hospitalization

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: clinical response at the test of cure visit

Secondary outcome:

clinical response at end of treatment and follow-up visit;

microbiological response at test of cure visit

change in Community acquired pneumonia symptom questionnaire.

Safety and tolerability will be measured by adverse event (AE) reporting including mortality, vital signs, physical examinations and safety laboratory results

Population pharmacokinetics

healthcare resource utilization


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Pfizer Investigational Site, Seoul 138-736, Korea, Republic of

Pfizer Investigational Site, Bialystok 15-003, Poland

Pfizer Investigational Site, Brzesko 32-800, Poland

Pfizer Investigational Site, Krakow 30-901, Poland

Pfizer Investigational Site, Lodz 90-153, Poland

Pfizer Investigational Site, Poznan 60-569, Poland

Pfizer Investigational Site, Proszowice 32-100, Poland

Pfizer Investigational Site, Warszawa 03-401, Poland

Pfizer Investigational Site, Chula Vista, California 91911, United States

Pfizer Investigational Site, Oceanside, California 92056, United States

Pfizer Investigational Site, Moline, Illinois 61265, United States

Pfizer Investigational Site, Rock Island, Illinois 61201, United States

Pfizer Investigational Site, Minneapolis, Minnesota 55422, United States

Pfizer Investigational Site, Akron, Ohio 44309, United States

Pfizer Investigational Site, Akron, Ohio 44304, United States

Pfizer Investigational Site, Akron, Ohio 44310, United States

Pfizer Investigational Site, Hamilton, Ontario L8L 2X2, Canada

Pfizer Investigational Site, Hamilton, Ontario L8N 3Z5, Canada

Pfizer Investigational Site, Hamilton, Ontario L8V 1C3, Canada

Pfizer Investigational Site, Brisbane, Queensland 4102, Australia

Pfizer Investigational Site, Provo, Utah 84604, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: January 2009
Last updated: September 21, 2009

Page last updated: August 23, 2015

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