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
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
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
NCT ID
NCT00430937
First Posted
February 1, 2007
Last Updated
July 10, 2012
Sponsor
Novartis Pharmaceuticals
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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