A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization
Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 12, 2009
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: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Oceanside, California 92056, United States; Recruiting
Pfizer Investigational Site, Atlantis, Florida 33462, United States; Not yet recruiting
Pfizer Investigational Site, Minneapolis, Minnesota 55422, United States; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2009
Ending date: May 2009
Last updated: February 9, 2009
|
