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Skin InfectionsPhase 2NCT00671580

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

A Phase 2 study testing PZ-601 in people with Skin Infections, run by Protez Pharmaceuticals, Inc. at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Skin Infections
What is being tested?
PZ-601
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
15 sitesUnited States
Study dates
May 2008to Feb 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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;

Who cannot join

  • 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)
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  • 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
  • Requiring concomitant administration of systemic corticosteroids greater than 40 mg/day of prednisolone (or equivalent)
  • Treatment with cancer chemotherapy, radiotherapy, or potent, non-corticosteroid immunosuppressant drugs (eg, cyclosporine, azathioprine, tacrolimus, immune-modulating monoclonal antibody therapy, etc.) within the 3 months prior to study enrollment
  • Concomitant therapy with medications known to lower seizure threshold or those patients with a history of seizure disorder
  • Concomitant therapy with medications known to be associated with QTc prolongation potential (eg, Class IA and Class III anti-arrhythmic agents)
  • History or significant cardiac disease defined by the following:
  • New York Heart Association (NYHA) Class III or IV heart failure
  • History or risk of ventricular arrhythmia (excluding isolated premature ventricular contractions [PVC's] or consecutive PVC's <10 beats), Torsades de Pointes, 2nd or 3rd degree AV block, or QTc interval >470 mm/sec
  • History of any hypersensitivity or allergic reaction to beta-lactam drugs such as carbapenems, penicillins, or cephalosporins
  • History of any hypersensitivity or allergic reaction to vancomycin or history of Red Man Syndrome
  • Any planned medical intervention or personal event that might interfere with the ability to comply with the study requirements
  • Any condition that, in the opinion of the principal investigator, would compromise the safety of the patient or the quality of the data
  • Life expectancy of less than 3 months from the time of enrollment
  • Use of an investigational drug or device (ie, a drug or device without an FDA approved indication) within the previous 30 days
  • Prior participation in this protocol
  • Unable or unwilling to adhere to the study-specified procedures and restrictions

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Summa Health System

    Akron, Ohio, 44304

  • Gulf Coast Research, LLC

    Baton Rouge, Louisiana, 70808

  • Mercury Street Medical Group

    Butte, Montana, 59701

  • eStudySite - Sharp Chula Vista

    Chula Vista, California, 91911

  • University of Missouri Health Care

    Columbia, Missouri, 65212

  • Remington-Davis, Inc.

    Columbus, Ohio, 43215

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Novellus Research Site

    Fountain Valley, California, 92708

  • Infectious Disease of Indiana, PSC

    Indianapolis, Indiana, 46280

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Novellus Research Site

    Long Beach, California, 90806

  • eStudySite - Tri-City Medical Center

    Oceanside, California, 92056

  • eStudySite - Good Samaritan Hospital

    San Jose, California, 95124

  • Holy Name Hospital Institute for Clinical Research

    Teaneck, New Jersey, 07666

  • NewBridge Medical Research

    Warren, Pennsylvania, 16365

Other trials in United States

About this 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

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.

Read the 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.

Conditions
Skin Infections
Being tested
PZ-601, Standard of Care
Keywords
Skin Infections, Complicated Skin and Skin Structure Infections
Medical subject headings
Cellulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PZ-601Drug

    750 mg

  • PZ-601Drug

    1000 mg

  • Standard of CareDrug

    as directed

Study groups in NCT00671580
Study groupRoleWhat they receive
AExperimentalPZ-601
Receives: Drug: PZ-601
BExperimentalPZ-601
Receives: Drug: PZ-601
CActive comparatorStandard of Care
Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 6 weeks

Secondary outcomes (7)

  1. Clinical Response in the Clinically Evaluable (CE) population at the End of Treatment (EOT) visit

    Measured: Up to 4 weeks

  2. Clinical Response in the Intent-to-Treat (ITT), Microbiological ITT (mITT), and Microbiologically Evaluable (ME) populations at the Test of Cure (TOC) visit

    Measured: Up to 4 weeks

  3. Clinical Response in the Intent-to-Treat (ITT), Microbiological ITT (mITT), and Microbiologically Evaluable (ME) populations at the End of Treatment (EOT) visit

    Measured: Up to 4 weeks

  4. By-pathogen and by-patient Microbiological Response in the Microbiological ITT (mITT) and Microbiologically Evaluable (ME) populations at the Test of Cure (TOC) visit

    Measured: Up to 4 weeks

  5. By-pathogen and by-patient Microbiological Response in the Microbiological ITT (mITT) and Microbiologically Evaluable (ME) populations at the End of Treatment (EOT) visit

    Measured: Up to 4 weeks

  6. Overall combined Clinical and Microbiological Response in the Microbiological ITT (mITT) and Microbiologically Evaluable (ME) populations at the Test of Cure (TOC) visit

    Measured: Up to 4 weeks

  7. Overall combined Clinical and Microbiological Response in the Microbiological ITT (mITT) and Microbiologically Evaluable (ME) populations at the End of Therapy (EOT) visit

    Measured: Up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00671580
Sponsor's protocol ID
PZ-601-02
Status last verified
Jun 2009
First submitted
1 May 2008
Last updated
3 Jun 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PZ-601 in people with Skin Infections, run by Protez Pharmaceuticals, Inc. at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00671580.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2009.

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