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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 )

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.

Condition or disease Intervention/treatment Phase
Infections Drug: Daptomycin Drug: Vancomycin or Semi-Synthetic Penicillins (SSPs) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : March 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.


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.

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,




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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. ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184872


Locations
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Austria
Novartis Investigative Site
Graz, Austria
Novartis Investigative Site
Vienna, Austria
Germany
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Homburg, Germany
Novartis Investigative Site
Magdeburg, Germany
Novartis Investigative Site
Mannheim, Germany
Novartis Investigative Site
Muenster, Germany
Novartis Investigative Site
Tuebingen, Germany
Italy
Novartis Investigative Site
Pisa, Italy
Russian Federation
Novartis Investigative Site (1)
Moscow, Russian Federation
Novartis Investigative Site
Novosibirsk, Russian Federation
Novartis Investigative Site (2)
Saint Petersburg, Russian Federation
Novartis Investigative Site
Yaroslavi, Russian Federation
Spain
Novartis Investigative Site (1)
Madrid, Spain
Novartis Investigative Site
Santander, Spain
Novartis Investigative Site
Seville, Spain
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmceuticals Novartis Pharmceuticals

Publications:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01184872     History of Changes
Other Study ID Numbers: CCBC134A2404
2009-014391-22 ( EudraCT Number )
First Posted: August 19, 2010    Key Record Dates
Results First Posted: April 18, 2012
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Skin infection
Daptomycin
Elderly
Gram positive
Complicated skin and soft tissue infections

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Soft Tissue Infections
Vancomycin
Penicillins
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents