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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

Page last updated: February 12, 2009

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