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Sponsored by: |
Protez Pharmaceuticals, Inc. |
Information provided by: | Protez Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00671580 |
The purpose of this study is to evaluate the potential effect and safety of two different doses of PZ-601 and to compare this with another antibiotic that is approved by the US Food and Drug Administration (also known as FDA) to treat adults with skin and skin structure infections.
Condition | Intervention | Phase |
Skin Infections |
Drug: PZ-601 Drug: Standard of Care |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized, Observer-Blind, Multi-Center Study to Evaluate the Safety, Potential Efficacy, and Pharmacokinetics of Two Dosing Regimens of Intravenous PZ-601 and Standard of Care in the Treatment of Complicated Skin and Skin Structure Infections |
Estimated Enrollment: | 99 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
PZ-601
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Drug: PZ-601
750 mg
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B: Experimental
PZ-601
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Drug: PZ-601
1000 mg
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C: Active Comparator
Standard of Care
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Drug: Standard of Care
as directed
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PZ-601 is a novel investigational carbapenem antibiotic with an antimicrobial spectrum of activity that includes pathogens responsible for community-acquired bacterial infections as well as multidrug-resistant Gram-positive pathogens - MRSA and vancomycin-resistant enterococci. PZ-601 also has activity against Gram-negative organisms including cephalosporin and quinolone resistant Enterobacteriaceae as well as Bacteriodes fragilis and peptostreptococci. Based on the antimicrobial profile, PZ-601 is a potentially promising agent for the treatment of complicated skin and skin structure infections.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of complicated skin and skin structure infection defined as infection which meets the following criteria:
Involves deeper soft tissue and/or require significant surgical intervention such as:
Presents with at least TWO of the following local symptoms:
At least ONE of the following systemic signs of infection
Exclusion Criteria:
Received more than 24 hours of systemic antibiotic therapy within 96 hours of initiation of study medication for the current episode of cSSSI, unless:
cSSSI of the following categories:
History or significant cardiac disease defined by the following:
United States, California | |||||
eStudySite - Good Samaritan Hospital | Recruiting | ||||
San Jose, California, United States, 95124 | |||||
Contact: Katherine Ersted 408-355-2320 kersted@estudysite.com | |||||
Principal Investigator: James Guetzkow, MD | |||||
eStudySite - Tri-City Medical Center | Recruiting | ||||
Oceanside, California, United States, 92056 | |||||
Contact: David Westenberger 760-631-3056 dwestenberger@estudysite.com | |||||
Principal Investigator: Paul Manos, DO | |||||
eStudySite - Sharp Chula Vista | Recruiting | ||||
Chula Vista, California, United States, 91911 | |||||
Contact: Adam Danielski 619-955-5246 adanielski@estudysite.com | |||||
Principal Investigator: Purvi Mehra, MD | |||||
United States, Louisiana | |||||
Gulf Coast Research, LLC | Recruiting | ||||
Baton Rouge, Louisiana, United States, 70808 | |||||
Contact: Naomy Granger, LPN, CCRC 225-757-1084 ext 308 naomy@gulfcostra.com | |||||
Principal Investigator: John M Prestigiacomo, MD | |||||
United States, Michigan | |||||
Henry Ford Hospital | Recruiting | ||||
Detroit, Michigan, United States, 48202 | |||||
Contact: Carol Nini 313-916-3138 cnini1@hfhs.org | |||||
Principal Investigator: Jose Vazquez, MD | |||||
United States, Montana | |||||
Mercury Street Medical Group | Recruiting | ||||
Butte, Montana, United States, 59701 | |||||
Contact: Michelle Harrington 406-723-1385 michelle.harrington@gfclinic.com | |||||
Principal Investigator: John Pullman, MD | |||||
United States, Ohio | |||||
Remington-Davis, Inc. | Recruiting | ||||
Columbus, Ohio, United States, 43215 | |||||
Contact: Jennifer Botte, RN 614-487-2560 jbotte@remdavis.com | |||||
Principal Investigator: Ian M Baird, MD | |||||
Summa Health System | Recruiting | ||||
Akron, Ohio, United States, 44304 | |||||
Contact: Sara-Jane Salstrom 330-375-4293 salstros@summa-health.org | |||||
Principal Investigator: Thomas File, MD |
Protez Pharmaceuticals, Inc. |
Responsible Party: | Protez Pharmaceuticals, Inc. ( Shelley Fayocavitz, Associate Director, Clinical Study Management ) |
Study ID Numbers: | PZ-601-02 |
First Received: | May 1, 2008 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00671580 |
Health Authority: | United States: Food and Drug Administration |
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