A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization
Information source: Pfizer
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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
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.
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
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
healthcare resource utilization
Minimum age: 18 Years.
Maximum age: N/A.
- 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.
- 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
To obtain contact information for a study center near you, click here.
Starting date: January 2009
Last updated: September 21, 2009