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Cubicin(R) for Complicated Post-surgical Wound Infections (PSW)

Primary Purpose

Wound Infections

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
daptomycin
Sponsored by
Cubist Pharmaceuticals LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Infections focused on measuring post-surgical, wound infection, superficial, deep, surgical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Read and signed informed consent form
  • female of childbearing potential, negative pregnancy test result
  • Confirmed diagnosis of post-surgical wound infections known or suspected (based on Gram stain) to be due to Gram-positive organisms obtained within 3 calendar days prior to first dose of study medication
  • Onset of surgical wound infection within 30 days after surgery
  • At least three clinical signs and symptoms of skin infection

Exclusion Criteria:

  • previous systemic antimicrobial therapy exceeding 24 hours duration administered anytime during 72 hours prior to the first dose of study drug
  • Uncomplicated surgical infections (eg, stitch abscesses)
  • osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection
  • Any type of space infection
  • Conditions requiring surgical removal of wound infection
  • necrotizing fasciitis, synergistic gangrene, Clostridial myonecrosis (gas gangrene), or Fournier's gangrene;
  • Foreign material involved in the post-surgical wound infection
  • Known to be allergic or intolerant to study medication
  • Creatinine Clearance (CLCR) <30 mL/min
  • history of neurological disease (eg, Guillain-Barré, multiple sclerosis)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Investigator's assessment of clinical response based on improvement of signs and symptoms

    Secondary Outcome Measures

    Incidence of adverse events
    eradication of pathogens isolated at admission
    overall therapeutic outcome based on agreement between clinical efficacy and microbiological response

    Full Information

    First Posted
    March 31, 2008
    Last Updated
    August 28, 2017
    Sponsor
    Cubist Pharmaceuticals LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00651131
    Brief Title
    Cubicin(R) for Complicated Post-surgical Wound Infections
    Acronym
    PSW
    Official Title
    Cubicin(R) for Complicated Post-surgical Wound Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    terminated due to slow enrollment
    Study Start Date
    June 1, 2004 (Actual)
    Primary Completion Date
    March 1, 2005 (Actual)
    Study Completion Date
    March 1, 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cubist Pharmaceuticals LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections
    Detailed Description
    A multi-center, single-arm, open-label, non-comparative study to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections. Adjunctive treatment with aztreonam and/or metronidazole could be given for Gram-negative and/or anaerobic organisms. Patients are to be treated for a period of 7-14 days as specified in the package insert. An evaluation is to be performed on the day CUBICIN treatment is completed (assessment for outcome of cure, improved, failure or unable to evaluate). A follow-up is required for patients with an Investigator response of 'Improved' at the end of treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wound Infections
    Keywords
    post-surgical, wound infection, superficial, deep, surgical

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    69 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    daptomycin
    Other Intervention Name(s)
    Cubicin, daptomycin for injection, Cubicin (daptomycin for injection)
    Intervention Description
    daptomycin i.v. 4 mg/kg q24h for 7-14 days
    Primary Outcome Measure Information:
    Title
    Investigator's assessment of clinical response based on improvement of signs and symptoms
    Time Frame
    End of Therapy
    Secondary Outcome Measure Information:
    Title
    Incidence of adverse events
    Time Frame
    first dose to end of therapy
    Title
    eradication of pathogens isolated at admission
    Time Frame
    End of Therapy
    Title
    overall therapeutic outcome based on agreement between clinical efficacy and microbiological response
    Time Frame
    End of Therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Read and signed informed consent form female of childbearing potential, negative pregnancy test result Confirmed diagnosis of post-surgical wound infections known or suspected (based on Gram stain) to be due to Gram-positive organisms obtained within 3 calendar days prior to first dose of study medication Onset of surgical wound infection within 30 days after surgery At least three clinical signs and symptoms of skin infection Exclusion Criteria: previous systemic antimicrobial therapy exceeding 24 hours duration administered anytime during 72 hours prior to the first dose of study drug Uncomplicated surgical infections (eg, stitch abscesses) osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection Any type of space infection Conditions requiring surgical removal of wound infection necrotizing fasciitis, synergistic gangrene, Clostridial myonecrosis (gas gangrene), or Fournier's gangrene; Foreign material involved in the post-surgical wound infection Known to be allergic or intolerant to study medication Creatinine Clearance (CLCR) <30 mL/min history of neurological disease (eg, Guillain-Barré, multiple sclerosis)

    12. IPD Sharing Statement

    Learn more about this trial

    Cubicin(R) for Complicated Post-surgical Wound Infections

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