Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci 


Tracking Information

Start Date  ICMJEJanuary 2007
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2008)		Incidence of elevated CPK (defined as any CPK value above 500 U/L based on central laboratory assessments) [ Time Frame: 5 to 7 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ICMJE 
 (submitted: August 16, 2007)		Incidence of elevated CPK (defined as any CPK value above 500 U/L based on central laboratory assessments) [ Time Frame: 5 to 7 weeks ]
Change HistoryComplete list of historical versions of study NCT00428844 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: March 19, 2008)		General safety (AEs and SAEs, laboratory analytes, vital signs, concomitant medications and physical examination findings) and efficacy (clinical response, microbiological response, and overall therapeutic response and clinical relapse) [ Time Frame: 5 to 7 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJE 
 (submitted: August 16, 2007)		General safety (AEs and SAEs, laboratory analytes, vital signs, concomitant medications and physical examination findings) and efficacy (clinical response, microbiological response, and overall therapeutic response and clinical relapse) [ Time Frame: 5 to 7 weeks ]

Descriptive Information

Brief Title  ICMJEStudy of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
Official Title  ICMJEA Phase 2 Randomized Study Investigating the Safety, Efficacy and Pharmacokinetics of Daptomycin 6 mg/kg and 8 mg/kg Versus Comparator in the Treatment of Subjects Undergoing Surgical Standard of Care for Osteomyelitis Associated With an Infected Prosthetic Hip or Knee Joint Caused by Staphylococci
Brief Summary

This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci. These types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEOsteomyelitis
Intervention  ICMJE
  • Drug: daptomycin
    6 mg/kg
    Other Name: Cubicin
  • Drug: daptomycin
    8 mg/kg
    Other Name: Cubicin
  • Drug: vancomycin
    1 gm
    Other Name: Vancocin
  • Drug: teicoplanin
    6 mg/kg; This drug used only at UK sites
    Other Name: Targocid
  • Drug: nafcillin
    1-2 gm
    Other Name: Unipen
  • Drug: oxacillin
    1-2 gm
    Other Name: Bactocill
  • Drug: flucloxacillin
    1-2 mg
    Other Name: Fluclox
Study Arms / Comparison Groups
  • 1: Experimental
    Daptomycin 6 mg/kg
    Intervention: Drug: daptomycin
  • 2: Experimental
    Daptomycin 8 mg/kg
    Intervention: Drug: daptomycin
  • 3: Active Comparator
    vancomycin 1 gm teicoplanin 6 mg/kg nafcillin 1-2 gm oxacillin 1-2 gm flucloxacillin 1-2 gm
    Interventions:
    • Drug: vancomycin
    • Drug: teicoplanin
    • Drug: nafcillin
    • Drug: oxacillin
    • Drug: flucloxacillin

Recruitment Information

Recruitment Status  ICMJERecruiting
Estimated Enrollment  ICMJE72
Estimated Completion DateJuly 2010
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must be between the ages of 18 and 80, inclusive
  • Subject must have a diagnosis of prosthetic joint infection (PJI) in a hip or knee joint which has never previously been totally revised because of an infection and for which they are anticipated to undergo a two-stage replacement surgery
  • Subject must have a Positive microbiological identifier of staphylococci.
  • If Subject is female of childbearing potential, must be willing to practice reliable birth control

Exclusion Criteria:

  • Subject has permanent intravascular prosthetic material such as heart valves or pacemakers
  • Subject has a creatinine clearance (CLCR) <30 mL/min as determined by the Cockcroft-Gault equation using actual body weight.
  • Subject has significant hepatic dysfunction
  • Subject has a fungal or mycobacterial PJI
  • Subject is known to be HIV-infected with CD4 count ≤ 200 cells/ mm3
  • Subject has an abnormal creatine phosphokinase (CPK) (elevated CPK level ≥ 2x ULN) at baseline as measured by central laboratory
  • Subject is currently under treatment with chemotherapeutic agents excluding chronic maintenance therapy (e.g. tamoxifen to prevent relapse of primary breast cancer)
  • Subject is pregnant, nursing, or lactating.
  • Subject is receiving or is expected to receive chronic immunosuppressive therapy during the study.
GenderBoth
Ages18 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Ed Campanaro781-860-8318ed.campanaro@cubist.com
Location Countries  ICMJEUnited States,   Russian Federation,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00428844
Responsible PartyEd Campanaro, VP ClinOps and Data Mgmt, Cubist Pharmaceuticals
Study ID Numbers  ICMJEDAP-OST-06-02
Study Sponsor  ICMJECubist Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Margarita Cancio, MDInfectious Disease Association of Tampa Bay
Information Provided ByCubist Pharmaceuticals