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Trial record 11 of 20 for:    Oxacillin

Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections

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ClinicalTrials.gov Identifier: NCT01184872
Recruitment Status : Completed
First Posted : August 19, 2010
Results First Posted : April 18, 2012
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE February 18, 2010
First Posted Date  ICMJE August 19, 2010
Results First Submitted Date  ICMJE March 22, 2012
Results First Posted Date  ICMJE April 18, 2012
Last Update Posted Date July 13, 2012
Study Start Date  ICMJE March 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2012)
Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit [ Time Frame: Baseline and 7 to 14 days after end of therapy ]
Success: Clinically significant signs and symptoms associated with the skin infection present at the pre-treatment infection site resolved (cure), or improved without need of further antibacterial therapy. Failure: Persistence or progression of signs and symptoms or development of new clinical signs and symptoms at the infection site, or concomitant antibacterial therapy with activity against isolated organisms, or treatment duration longer than pre-specified, or switch back to intravenous therapy due to relapse, or requirement of a major surgical procedure as adjunct or follow-up therapy.
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
Evaluate and descriptively compare clinical success at the Test-Of-Cure visit in elderly patients with Complicate Skin and Soft Tissue Infections, treated with either 4 or 6 mg/kg once daily daptomycin and with comparator. [ Time Frame: 7 to 14 days after end of therapy (Test-of-Cure visit) (therapy duration is 14 to 28 days) ]
Change History Complete list of historical versions of study NCT01184872 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2012)
  • Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit [ Time Frame: Baseline and 7 to 14 days after end of therapy ]
    Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated or presumed to be eradicated at the Test-of-Cure (TOC) evaluation and a super infecting pathogen was not isolated either prior to or at the TOC evaluation. Microbiological Failure: Persistence or relapse / re-infection of one or more infecting Gram-positive pathogens or isolation of a super infecting pathogen prior to or at the TOC evaluation.
  • Duration of Treatment (Intravenous) [ Time Frame: Up to 28 days ]
    Duration of treatment is the interval from first to last intravenous (i.v.) administration. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.
  • Duration of Treatment (Intravenous and Oral) [ Time Frame: Up to 28 days ]
    Duration of treatment is the interval from first to last intravenous (i.v.) or to last oral administration if patients switched to an oral antibiotic therapy. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.
  • Number of Patients With Adverse Events, Serious Adverse Events and Death [ Time Frame: Continuously from baseline up to 28 days after end of antibiotic treatment. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
  • Evaluate the microbiological outcome of daptomycin in comparison to that of comparator as measured by the proportion of patients achieving bacteriological eradication of Gram-positive baseline pathogens at the Test-Of-Cure visit. [ Time Frame: 7 to 14 days after end of therapy (therapy duration is 14 to 28 days) ]
  • To evaluate the duration of treatment (i.v., i.v. + oral). [ Time Frame: End of therapy ]
  • To evaluate and descriptively compare adverse event frequencies and laboratory abnormalities in elderly patients treated with 4 and 6 mg/kg once daily of i.v daptomycin and with comparator (Safety evaluation). [ Time Frame: Throughout the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections
Official Title  ICMJE An Open Label, Multi-center, Randomized, Comparative Phase IIIb Study to Compare Efficacy and Safety of Intravenous (i.v.) Daptomycin With That of Semi-Synthetic Penicillins (SSPs) or Vancomycin in the Treatment of Elderly Patients (Aged ≥ 65 Years) With Complicated Skin and Soft Tissue Infections (cSSTI)
Brief Summary The purpose of this study is to provide data documenting the efficacy of daptomycin in elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infections
Intervention  ICMJE
  • Drug: Daptomycin

    Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

    Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

  • Drug: Vancomycin or Semi-Synthetic Penicillins (SSPs)

    Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

    Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

    Other Names:
    • Oxacillin,
    • Cloxacillin,
    • Flucloxacillin,
Study Arms  ICMJE
  • Experimental: Daptomycin

    Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

    Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

    Intervention: Drug: Daptomycin
  • Active Comparator: Vancomycin or Semi-Synthetic Penicillins (SSPs)

    Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

    Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

    Intervention: Drug: Vancomycin or Semi-Synthetic Penicillins (SSPs)
Publications * Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI; Daptomycin 98-01 and 99-01 Investigators. The safety and efficacy of daptomycin for the treatment of complicated skin and skin-structure infections. Clin Infect Dis. 2004 Jun 15;38(12):1673-81. Epub 2004 May 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2010)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

Patients 65 years or older with infection of sufficient severity to require in-patient hospitalization, with parenteral antimicrobial therapy for at least 96 hours.

Patients who have a diagnosis of Gram-positive complicated Skin and Soft Tissue Infections (cSSTIs) with or without bacteremia:

  • Wound infections,
  • Major abscesses with or without recognized preceding trauma, that require antibiotic therapy in addition to surgical incision and drainage,
  • Severe carbunculosis,
  • Infected ulcers (except patients with multiple infected ulcers) associated with: diabetes, vascular insufficiency, pressure (i.e., decubitus ulcers).

Exclusion criteria:

Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (e.g., amputation).

Minor or superficial skin infections (e.g., furuncles, simple abscesses, acne, impetigo).

Cellulitis, including erysipelas, not associated with complicating factors. However, patients with cellulitis associated with more serious infection (e.g., surgical wound, diabetic ulcer, deep tissue) can be enrolled (proportion of these patients will be limited to 30%).

Infections for which outcome is difficult to assess:

  • Perirectal abscess,
  • Hidradenitis suppurativa,
  • Gangrene,
  • Infected human or animal bites,
  • Multiple infected ulcers at distant sites,
  • Infected burns (only third degree burn wound or wound area of more than 10 cm diameter),
  • Conditions requiring emergency surgery including necrotizing fasciitis.

Medical conditions:

  • History of significant allergy or intolerance to Vancomycin or Daptomycin. Hypersensitivity to SSPs penicillins is not an exclusion criterion,
  • Concomitant clinically suspected or confirmed other site of infection or disorder at study entry that may interfere with the evaluation in this protocol,
  • Infections associated with a permanent prosthetic device that will not be removed within 24 hours after enrolment,
  • Known or suspected HIV infection with a CD4+ T-cell count < 500/μL (HIV testing is not required),
  • Severe hepatic disease (Child-Pugh Class C) or ALT and/or AST > 5 times ULN and/ or total bilirubin > 2 times ULN at screening,
  • Calculated creatinine clearance by the Cockcroft-Gault equation using actual body weight < 30 mL/min or any type of dialysis,
  • Treatment with any investigational agent or device within 30 days of study drug administration.

Exclusion criteria related to medications:

  • Previous systemic antibacterial therapy for the treatment of Gram-positive complicated skin and soft tissue infections for more than 24 hours within 48 hours prior to the day of first infusion of study drug unless:
  • The previous antibacterial therapy was administered for 3 or more calendar days with either worsening or no improvement in the clinical signs and symptoms of cSSTIs, and was not Vancomycin or SSPs.

Other protocol-defined inclusion/exclusion criteria applied.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   Italy,   Russian Federation,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01184872
Other Study ID Numbers  ICMJE CCBC134A2404
2009-014391-22 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmceuticals Novartis Pharmceuticals
PRS Account Novartis
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP