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Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections

Primary Purpose

Skin Diseases, Infectious, Soft Tissue Infections

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Daptomycin
Vancomycin
Teicoplanin
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Diseases, Infectious focused on measuring Complicated Skin and Soft Tissue Infections. Daptomycin, Vancomycin, Teicoplanin, Complicated skin and soft tissue infections

Eligibility Criteria

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

Inclusion criteria:

  • Subjects with a diagnosis of cSSTI
  • Infection known or suspected (based on Gram's stain) to be due, at least partially, to Gram-positive bacteria.
  • Hospitalised subjects with clinical evidence of at least one of the following:I infected ulcers , major abscess. deep or extensive cellulitis, post-surgical / post-traumatic wound infection
  • Presence of at least two of the following: drainage and/or discharge from the infection site, redness, swelling and/or hardened skin, heat and/or localised warmth, pain and/or tenderness to touch, presence of pus.

Exclusion criteria:

  • cSSTIs of the following categories:

    • Infected burns,
    • Severely impaired arterial blood supply (such that the likelihood of amputation of the infected anatomical site is likely),
    • Decubitus ulcers,
    • Infected diabetic foot ulcers associated with osteomyelitis,
    • Infected human or animal bites, superficial infections or abscesses in an anatomic site, such as the rectal area, where the risk of anaerobic or Gram-negative pathogen involvement is high (e.g. perirectal abscess),
    • Necrotising fasciitis or gangrene,
    • cSSTI expected to require more than 14 days of intravenous antimicrobial therapy,
    • Skin and/or skin structure infection that can be treated by surgery alone,
    • Infections associated with a permanent prosthetic device that will not be removed within 2 days of study randomisation
  • Subjects with documented bacteraemia at Baseline or those with shock or hypotension
  • Concomitant clinically suspected or confirmed other site of infection or disorder at study entry that may interfere with the evaluations in this protocol
  • Treatment with vancomycin or teicoplanin within the past 48 hours, unless administered for less than 24 hours.
  • Subjects admitted to the hospital for conditions associated with rhabdomyolysis or those with an infection due to an organism known prior to study entry to be resistant to daptomycin, vancomycin or teicoplanin.
  • Previously diagnosed disease of immune function. Human Immunodeficiency Virus (HIV) infected subjects without Acquired Immune Deficiency Syndrome (AIDS) may be enrolled.
  • Subjects receiving oral steroids or receiving immunosuppressant drugs after organ transplant.
  • Absence of purulent material for initial culture and Gram's stain. Subjects with cellulitis may be enrolled in the absence of purulent material, provided that infection with a Gram-positive organism is suspected.
  • Subjects who have received more than 48 hours of any systemic antibiotic or topical antibiotic at the infection site with activity against Gram-positive pathogens, unless there is clinical evidence of treatment failure OR documented resistance in the identified Gram-positive pathogen to the previous antibiotic therapy.
  • cSSTI suspected or documented as being due exclusively to Gram-negative or anaerobic organisms based on epidemiology or on direct examination of a Gram-stained specimen.
  • Subjects diagnosed with pneumonia or those with severe renal impairment or hepatic disease
  • Previous history of hearing loss. Other protocol defined inclusion/exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Daptomycin

    Pooled Comparator

    Arm Description

    4 mg/kg intravenous (i.v.) once daily

    Outcomes

    Primary Outcome Measures

    Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the "Test of Cure" (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population.
    Success: Total resolution of clinically significant signs and symptoms of the infection site (cure) or improvement to such a level that no further antibacterial therapy was required (improvement). Failure: Persistence or progression of signs and symptoms after at least 3 days of study therapy, or development of new signs and symptoms at the infection site, or concomitant or additional antibacterial therapy with documented activity against isolated organisms, or a treatment duration greater than 14 days, or requirement of a major surgical procedure as adjunct or follow-up therapy.

    Secondary Outcome Measures

    Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.
    Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated at the TOC evaluation and a superinfecting pathogen was not isolated either prior to or at the TOC evaluation. Microbiological Failure: Persistence of one or more infecting Gram-positive pathogens or isolation of a superinfecting pathogen prior to or at the TOC evaluation.

    Full Information

    First Posted
    February 1, 2007
    Last Updated
    July 10, 2012
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00430937
    Brief Title
    Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections
    Official Title
    A Multicenter, Randomized, Assessor-Blind Study to Evaluate Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections (cSSTI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Terminated
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    This study evaluated the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Diseases, Infectious, Soft Tissue Infections
    Keywords
    Complicated Skin and Soft Tissue Infections. Daptomycin, Vancomycin, Teicoplanin, Complicated skin and soft tissue infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    194 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Daptomycin
    Arm Type
    Experimental
    Arm Description
    4 mg/kg intravenous (i.v.) once daily
    Arm Title
    Pooled Comparator
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Daptomycin
    Other Intervention Name(s)
    Cubicin
    Intervention Description
    4 mg/kg intravenous once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Vancomycin
    Other Intervention Name(s)
    Vancocin
    Intervention Description
    1 g intravenous twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    Teicoplanin
    Other Intervention Name(s)
    Targocid
    Intervention Description
    400 mg intravenous once daily following a loading dose of 400 mg administered at 0, 12, 24 hours on day one.
    Primary Outcome Measure Information:
    Title
    Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the "Test of Cure" (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population.
    Description
    Success: Total resolution of clinically significant signs and symptoms of the infection site (cure) or improvement to such a level that no further antibacterial therapy was required (improvement). Failure: Persistence or progression of signs and symptoms after at least 3 days of study therapy, or development of new signs and symptoms at the infection site, or concomitant or additional antibacterial therapy with documented activity against isolated organisms, or a treatment duration greater than 14 days, or requirement of a major surgical procedure as adjunct or follow-up therapy.
    Time Frame
    Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks
    Secondary Outcome Measure Information:
    Title
    Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.
    Description
    Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated at the TOC evaluation and a superinfecting pathogen was not isolated either prior to or at the TOC evaluation. Microbiological Failure: Persistence of one or more infecting Gram-positive pathogens or isolation of a superinfecting pathogen prior to or at the TOC evaluation.
    Time Frame
    Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Subjects with a diagnosis of cSSTI Infection known or suspected (based on Gram's stain) to be due, at least partially, to Gram-positive bacteria. Hospitalised subjects with clinical evidence of at least one of the following:I infected ulcers , major abscess. deep or extensive cellulitis, post-surgical / post-traumatic wound infection Presence of at least two of the following: drainage and/or discharge from the infection site, redness, swelling and/or hardened skin, heat and/or localised warmth, pain and/or tenderness to touch, presence of pus. Exclusion criteria: cSSTIs of the following categories: Infected burns, Severely impaired arterial blood supply (such that the likelihood of amputation of the infected anatomical site is likely), Decubitus ulcers, Infected diabetic foot ulcers associated with osteomyelitis, Infected human or animal bites, superficial infections or abscesses in an anatomic site, such as the rectal area, where the risk of anaerobic or Gram-negative pathogen involvement is high (e.g. perirectal abscess), Necrotising fasciitis or gangrene, cSSTI expected to require more than 14 days of intravenous antimicrobial therapy, Skin and/or skin structure infection that can be treated by surgery alone, Infections associated with a permanent prosthetic device that will not be removed within 2 days of study randomisation Subjects with documented bacteraemia at Baseline or those with shock or hypotension Concomitant clinically suspected or confirmed other site of infection or disorder at study entry that may interfere with the evaluations in this protocol Treatment with vancomycin or teicoplanin within the past 48 hours, unless administered for less than 24 hours. Subjects admitted to the hospital for conditions associated with rhabdomyolysis or those with an infection due to an organism known prior to study entry to be resistant to daptomycin, vancomycin or teicoplanin. Previously diagnosed disease of immune function. Human Immunodeficiency Virus (HIV) infected subjects without Acquired Immune Deficiency Syndrome (AIDS) may be enrolled. Subjects receiving oral steroids or receiving immunosuppressant drugs after organ transplant. Absence of purulent material for initial culture and Gram's stain. Subjects with cellulitis may be enrolled in the absence of purulent material, provided that infection with a Gram-positive organism is suspected. Subjects who have received more than 48 hours of any systemic antibiotic or topical antibiotic at the infection site with activity against Gram-positive pathogens, unless there is clinical evidence of treatment failure OR documented resistance in the identified Gram-positive pathogen to the previous antibiotic therapy. cSSTI suspected or documented as being due exclusively to Gram-negative or anaerobic organisms based on epidemiology or on direct examination of a Gram-stained specimen. Subjects diagnosed with pneumonia or those with severe renal impairment or hepatic disease Previous history of hearing loss. Other protocol defined inclusion/exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections

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