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

Protez Pharmaceuticals, Inc.14 sites in 1 country99 target enrollmentMay 2008

ConditionsSkin Infections

InterventionsPZ-601 Standard of Care

DrugsPZ-601 Standard of Care

Overview

Phase: Phase 2
Intervention: PZ-601
Conditions: Skin Infections
Sponsor: Protez Pharmaceuticals, Inc.
Enrollment: 99
Locations: 14
Primary Endpoint: The primary efficacy parameter is the proportion of patients experiencing clinical response based on improvement or resolution of clinical signs and symptoms of infection in the Clinically Evaluable population at the Test of Cure visit.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

February 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Protez Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•Written informed consent provided by the patient
•Males and females ≥ 18 years of age
•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

Exclusion Criteria

•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)
•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)
•Concomitant conditions requiring antimicrobial therapy that would interfere with the evaluability of the condition under study
•Anticipated need for prolonged antibiotic therapy (ie, \>14 days)
•Topical use of antimicrobials (excluding vaginally or topically administered antifungal agents)
•cSSSI known or suspected to be caused by fungal, parasitic or viral infections
•cSSSI of the following categories:
•infected diabetic foot ulcers or decubitus ulcer

Arms & Interventions

A

PZ-601

Intervention: PZ-601

B

PZ-601

Intervention: PZ-601

C

Standard of Care

Intervention: Standard of Care

Outcomes

Primary Outcomes

The primary efficacy parameter is the proportion of patients experiencing clinical response based on improvement or resolution of clinical signs and symptoms of infection in the Clinically Evaluable population at the Test of Cure visit.

Time Frame: up to 6 weeks

Secondary Outcomes

Clinical Response in the Intent-to-Treat (ITT), Microbiological ITT (mITT), and Microbiologically Evaluable (ME) populations at the End of Treatment (EOT) visit(Up to 4 weeks)
By-pathogen and by-patient Microbiological Response in the Microbiological ITT (mITT) and Microbiologically Evaluable (ME) populations at the Test of Cure (TOC) visit(Up to 4 weeks)
By-pathogen and by-patient Microbiological Response in the Microbiological ITT (mITT) and Microbiologically Evaluable (ME) populations at the End of Treatment (EOT) visit(Up to 4 weeks)
Overall combined Clinical and Microbiological Response in the Microbiological ITT (mITT) and Microbiologically Evaluable (ME) populations at the Test of Cure (TOC) visit(Up to 4 weeks)
Overall combined Clinical and Microbiological Response in the Microbiological ITT (mITT) and Microbiologically Evaluable (ME) populations at the End of Therapy (EOT) visit(Up to 4 weeks)
Clinical Response in the Clinically Evaluable (CE) population at the End of Treatment (EOT) visit(Up to 4 weeks)
Clinical Response in the Intent-to-Treat (ITT), Microbiological ITT (mITT), and Microbiologically Evaluable (ME) populations at the Test of Cure (TOC) visit(Up to 4 weeks)