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

NCT00671580 | Completed Phase 2

• 1 other identifier: PZ-601-02
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 15

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.

Conditions

Skin Infections

Keywords

Skin Infections; Complicated Skin and Skin Structure Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 6 weeks

Secondary Outcomes (7)

• 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

• 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

Study Arms (3)

A

EXPERIMENTAL

PZ-601

Drug: PZ-601

B

EXPERIMENTAL

PZ-601

Drug: PZ-601

C

ACTIVE COMPARATOR

Standard of Care

Drug: Standard of Care

Interventions

PZ-601 DRUG

750 mg

A

Standard of Care DRUG

as directed

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• infected ulcer (with the exception of multiple infected ulcers at distant sites.) Please Note: Patients with multiple sites of skin infection may be enrolled in the study. The most severely affected site or the one most likely to yield a positive culture should be chosen to follow throughout the course of evaluations.
• Presents with at least TWO of the following local symptoms:
• Purulent or seropurulent drainage/discharge
• Erythema
• Fluctuance

You may not qualify if:

• 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
• multiple infected ulcers at distant sites
• involve an ischemic ulcer due to peripheral vascular disease
• presence of gangrene of any etiology
• Necrotizing fasciitis or gas gangrene
• Infections resulting from human or animal bites (excluding infections secondary to arthropod bites)

Sponsors & Collaborators

• Protez Pharmaceuticals, Inc.: lead

Study Sites (15)

eStudySite - Sharp Chula Vista

Chula Vista, California, 91911, United States

Location

Novellus Research Site

Fountain Valley, California, 92708, United States

Location

Novellus Research Site

Long Beach, California, 90806, United States

Location

eStudySite - Tri-City Medical Center

Oceanside, California, 92056, United States

Location

eStudySite - Good Samaritan Hospital

San Jose, California, 95124, United States

Location

Infectious Disease of Indiana, PSC

Indianapolis, Indiana, 46280, United States

Location

Gulf Coast Research, LLC

Baton Rouge, Louisiana, 70808, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

Truman Medical Center - Hospital Hill

Kansas City, Missouri, 64108, United States

Location

Mercury Street Medical Group

Butte, Montana, 59701, United States

Location

Holy Name Hospital Institute for Clinical Research

Teaneck, New Jersey, 07666, United States

Location

Summa Health System

Akron, Ohio, 44304, United States

Location

Remington-Davis, Inc.

Columbus, Ohio, 43215, United States

Location

NewBridge Medical Research

Warren, Pennsylvania, 16365, United States

Location

MeSH Terms

Conditions

Cellulitis

Interventions

SM-216601; Standard of Care

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 5, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: June 3, 2009

Record last verified: 2009-06

Locations

US (15)