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COMPLETEDPHASE2

Safety, Potential Efficacy, and Pharmacokinetics of PZ-601 in the Treatment of Complicated Skin and Skin Structure Infection

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

NCT00671580•Protez Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent provided by the patient
•2. Males and females ≥ 18 years of age
•3. Diagnosis of complicated skin and skin structure infection defined as infection which meets the following criteria:
•* Suspected to be caused by bacterial pathogens, including multi-drug resistant organisms such as MRSA, and
•* Involves deeper soft tissue and/or require significant surgical intervention such as:
•* major abscesses
•* infected burn (less than or equal to 20% body surface area)
•* traumatic wound infection
•* deep/extensive cellulitis
•* surgical wound infection
+14 more criteria

Exclusion Criteria

•1. Female patients who are pregnant, lactating (breast milk feeding), or planning a pregnancy during the course of the study, or who are of child bearing potential and not using an acceptable method of birth control (ie, surgically sterile, intrauterine device, oral contraceptive plus barrier contraceptive, hormone delivery system plus barrier contraceptive or condom in combination with contraceptive cream, jelly or foam)
•2. Received more than 24 hours of systemic antibiotic therapy within 96 hours of initiation of study medication for the current episode of cSSSI, unless:
•* there is evidence of clinical failure following at least 48 hours of prior, non-study systemic therapy OR
•* there is microbiological evidence of failure (ie, Gram stain reveals WBC and at least one potential pathogen or isolation of an organism resistant to the prior therapy)
•3. Concomitant conditions requiring antimicrobial therapy that would interfere with the evaluability of the condition under study
•4. Anticipated need for prolonged antibiotic therapy (ie, \>14 days)
•5. Topical use of antimicrobials (excluding vaginally or topically administered antifungal agents)
•6. cSSSI known or suspected to be caused by fungal, parasitic or viral infections
•7. cSSSI of the following categories:
•* infected diabetic foot ulcers or decubitus ulcer
+30 more criteria

Locations (15)

eStudySite - Sharp Chula Vista

Chula Vista, California, United States

Novellus Research Site

Fountain Valley, California, United States

Novellus Research Site

Long Beach, California, United States

eStudySite - Tri-City Medical Center

Oceanside, California, United States

eStudySite - Good Samaritan Hospital

San Jose, California, United States

Infectious Disease of Indiana, PSC

Indianapolis, Indiana, United States

Gulf Coast Research, LLC

Baton Rouge, Louisiana, United States

Henry Ford Hospital

Detroit, Michigan, United States

University of Missouri Health Care

Columbia, Missouri, United States

Truman Medical Center - Hospital Hill

Kansas City, Missouri, United States

Key Dates

Start Date

May 1, 2008

Primary Completion Date

February 1, 2009

Completion Date

February 1, 2009

Last Updated

June 3, 2009

Enrollment

ESTIMATED participants

Conditions

Skin Infections

Interventions

PZ-601

DRUG

PZ-601

DRUG

Standard of Care

DRUG

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COMPLETEDPHASE3

Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA

NCT02814916

Methicillin-Resistant Staphylococcus AureusBacterial Infections+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety, Potential Efficacy, and Pharmacokinetics of PZ-601 in the Treatment of Complicated Skin and Skin Structure Infection

Inclusion Criteria

Exclusion Criteria

Burden of Recreational Water Illness Due to Exposure to Cyanobacteria and Their Toxins in Freshwater Beaches in Canada

Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA

Retapamulin Microdialysis Feasibility Study

Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA

Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.

The Natural History of Community-Associated MRSA Infections and Decolonization Strategies