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

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ClinicalTrials.gov Identifier: NCT00428844
Recruitment Status : Completed
First Posted : January 30, 2007
Results First Posted : June 14, 2011
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Tracking Information
First Submitted Date  ICMJE January 26, 2007
First Posted Date  ICMJE January 30, 2007
Results First Submitted Date  ICMJE March 16, 2011
Results First Posted Date  ICMJE June 14, 2011
Last Update Posted Date January 31, 2018
Actual Study Start Date  ICMJE June 26, 2007
Actual Primary Completion Date March 26, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2011)
Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L) [ Time Frame: From the 3rd day of therapy to 1 week post last dose (approximately week 7) ]
Number of subjects with CPK >500 U/L between Day 3 and 7 days following the last dose of study medication (Day 7P) as measured by the central laboratory.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00428844 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2011)
  • Safety - Notable Laboratory Abnormalities [ Time Frame: From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30) ]
    Summary of Notable Laboratory Abnormalities - description of the proportion of subjects within each treatment group that had clinical laboratory values outside the reference range.
  • Overall Clinical Outcome [ Time Frame: Approximately 6 weeks post last dose (approximately week 12) ]
    The sponsor determined overall clinical outcome based on blinded review of clinical, microbiological, and radiological response of the subject including, but not limited to, clinical signs and symptoms of PJI, microbiological assessments, radiographic findings, and surgical procedures performed. Subjects were a success if both clinical and microbiological responses were success. A subject who failed to respond clinically or microbiologically was a failure. If microbiological response was non-evaluable and/or clinical evaluation at TOC was not performed, the subject was non-evaluable.
  • Microbiological Response [ Time Frame: Approximately 6 weeks post last dose (approximately week 12) ]
    Sponsor's assessment of subject-level microbiological response at the test-of-cure visit for the modified Intent-to-Treat (mITT) population.
  • Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) [ Time Frame: Day 4 (steady state) ]
    The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.
  • Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss) [ Time Frame: Day 4 (steady state) ]
    The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
Official Title  ICMJE A 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteomyelitis
Intervention  ICMJE
  • Drug: daptomycin
    6 mg/kg
    Other Name: Cubicin
  • Drug: daptomycin
    8 mg/kg
    Other Name: Cubicin
  • Drug: vancomycin
    1 gram
    Other Name: Vancocin
  • Drug: teicoplanin
    6 mg/kg; used only at UK sites
    Other Name: Targocid
  • Drug: nafcillin
    1-2 gram
    Other Name: Unipen
  • Drug: oxacillin
    1-2 gram
    Other Name: Bactocill
  • Drug: flucloxacillin
    1-2 mg
    Other Name: Fluclox
Study Arms  ICMJE
  • Experimental: Daptomycin 6 mg/kg
    Daptomycin (6 mg/kg every 24 hours [q24h]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week).
    Intervention: Drug: daptomycin
  • Experimental: Daptomycin 8 mg/kg
    Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week).
    Intervention: Drug: daptomycin
  • Active Comparator: Comparator
    Vancomycin was administered at 1 gram every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
    Interventions:
    • Drug: vancomycin
    • Drug: teicoplanin
    • Drug: nafcillin
    • Drug: oxacillin
    • Drug: flucloxacillin
Publications * Byren I, Rege S, Campanaro E, Yankelev S, Anastasiou D, Kuropatkin G, Evans R. Randomized controlled trial of the safety and efficacy of Daptomycin versus standard-of-care therapy for management of patients with osteomyelitis associated with prosthetic devices undergoing two-stage revision arthroplasty. Antimicrob Agents Chemother. 2012 Nov;56(11):5626-32. doi: 10.1128/AAC.00038-12. Epub 2012 Aug 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: September 13, 2010)
75
Original Enrollment  ICMJE
 (submitted: January 29, 2007)
72
Actual Study Completion Date  ICMJE June 23, 2010
Actual Primary Completion Date March 26, 2010   (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00428844
Other Study ID Numbers  ICMJE 3009-016
DAP-OST-06-02 ( Other Identifier: Cubist Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party Cubist Pharmaceuticals LLC
Study Sponsor  ICMJE Cubist Pharmaceuticals LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alistair Wheeler, MD Cubist Pharmaceuticals, 65 Hayden Ave, Lexington, MA 02421, USA
PRS Account Cubist Pharmaceuticals LLC
Verification Date January 2018

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