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

Completed · Phase 2

Conditions studied: Skin Infections

In brief

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.

Key facts

Study ID

NCT00671580

Run by

Protez Pharmaceuticals, Inc.

People needed

99

Starts

2008-05-01

Expected to finish

2009-02-01

Last updated by the study team

2009-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Heat/Localized Warmth
• Pain/tenderness to palpation
• Swelling/induration
• At least ONE of the following systemic signs of infection
• Increased Temperature (≥100.4ºF/≥38.0ºC) measured orally or its equivalent (note: other methods of obtaining temperature are acceptable)
• WBC (>10,000 cells/mm3)
• Immature neutrophils (>10% band forms regardless of the total peripheral white count)
• Require initial hospitalization with at least 7 days of parenteral therapy for treatment of suspected cSSSI infection
• Ability to obtain a culture and Gram stain of the cSSSI site within 48 hours prior to the initiation of study medication;

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)
• Known or suspected osteomyelitis or septic arthritis
• Superinfected eczema or other chronic medical conditions (eg, atopic dermatitis, hidradentitis suppurativa) characterized by prominent signs of inflammation for an extended period even after successful bacterial eradication
• Patients who have undergone more than two surgical interventions (defined as surgery that cannot be performed at the bedside) for treatment of cSSSI at the time of enrollment
• Patients who are expected to require more than two surgical interventions (defined as surgery that cannot be performed at the bedside) for treatment of cSSSI during the first 48 hours following study enrollment
• Infections complicated by the presence of prosthetic materials that will not be removed such as permanent intracardiac devices or joint replacement prosthesis
• Moderately or severely impaired renal function with known creatinine clearance <50 mL/min (based on the Cockcroft-Gault formula using ideal body weight)
• ALT or AST >3x upper limit of normal or bilirubin >1.5x upper limit of normal (ULN)
• Neutropenia defined as an absolute neutrophil count <500/mm3
• Thrombocytopenia defined as a platelet count <50,000 cells/mm3
• Infection with human immunodeficiency virus and a CD4 count known at the time of enrollment to be <200 cells/mm3 or another Acquired Immune Deficiency Syndrome (AIDS)-defining illness

Where it is running

• 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
• Mercury Street Medical Group — Butte, Montana, United States
• Holy Name Hospital Institute for Clinical Research — Teaneck, New Jersey, United States
• Summa Health System — Akron, Ohio, United States
• Remington-Davis, Inc. — Columbus, Ohio, United States
• NewBridge Medical Research — Warren, Pennsylvania, United States

Full record on ClinicalTrials.gov

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