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Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia (DASH)

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ClinicalTrials.gov Identifier: NCT02972983
Recruitment Status : Completed
First Posted : November 25, 2016
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Todd Lee, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date  ICMJE November 21, 2016
First Posted Date  ICMJE November 25, 2016
Last Update Posted Date September 22, 2020
Actual Study Start Date  ICMJE December 1, 2016
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
Blood culture clearance [ Time Frame: 5 days ]
Time between first positive and first negative blood culture
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Mortality [ Time Frame: 30 days ]
    Death from all causes (yes/no)
  • Adverse Reactions [ Time Frame: 5 days ]
    Daptomycin adverse reactions
  • Intensive care admission [ Time Frame: 30 days ]
    Admission to the intensive care unit (yes/no)
  • Metastatic infection [ Time Frame: 30 days ]
    The development of a new deep seated infection (e.g. osteomyelitis, abscess, endocarditis) not present at time of initial bacteremia
  • Recurrent infection [ Time Frame: 30 days ]
    The presence of a new positive blood culture occurring after the first negative culture and within 30 days of the initial positive
Original Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
  • Mortality [ Time Frame: 30 days ]
  • Adverse Reactions [ Time Frame: 5 days ]
    Daptomycin adverse reactions
  • Intensive care admission [ Time Frame: 30 days ]
  • Metastatic infection [ Time Frame: 30 days ]
    The development of a new deep seated infection (e.g. osteomyelitis, abscess, endocarditis) not present at time of initial bacteremia
  • Recurrent infection [ Time Frame: 30 days ]
    The presence of a new positive blood culture occurring after the first negative culture and within 30 days of the initial positive
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia
Official Title  ICMJE Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia
Brief Summary The purpose of our study is to examine the effects of a second antibiotic, daptomycin, in combination with a beta lactam antibiotic on treating bloodstream infection caused by methicillin-susceptible S. aureus.
Detailed Description

When patients have a blood infection with methicillin-susceptible S. aureus, they will all be treated with the usual standard of care, including abeta-lactam antibiotic, have their blood tested daily for the presence of the infection until they test negative, as well as an ultrasound of the heart to rule out an infection of the heart valves, as well as have any catheters removed (if possible) to ensure adequate control of the infection.

This study involves adding a second antibiotic, daptomycin, to the treatment regimen of half of the patients enrolled in this study. Daptomycin is approved by Health Canada for treating blood infections due to Staphylococcus aureus. It is currently not used in combination with a beta-lactam for these infections because there is insufficient evidence of benefit to justify the cost.

The study participants will receive an additional daily iv therapy which will consist of either daptomycin or a placebo for a total of five days while admitted to the hospital. During this time, the participants will continue to have their blood drawn to assess for the presence of bacteria. The participants' liver and muscle enzymes will also be measured on the first and fifth day of therapy to test for potential side effects of the daptomycin.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Methicillin Susceptible Staphylococcus Aureus Septicemia
  • Bacteremia
Intervention  ICMJE
  • Drug: Daptomycin
    Adjuvant therapy for up to five days
    Other Name: Cubicin
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    51 patients receiving a daily placebo infusion for five days on top of standard of care treatment for methicillin-sensitive Staphylococcus aureus (MSSA) bacteremia
    Intervention: Other: Placebo
  • Experimental: Daptomycin
    51 patients receiving daily daptomycin infusion for five days on top of standard of care treatment for MSSA bacteremia
    Intervention: Drug: Daptomycin
Publications *

*   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: November 23, 2016)
102
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2019
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient has a methicillin susceptible Staphylococcus aureus bacteremia.

Exclusion Criteria:

  • Underlying terminal illness
  • Significant contraindication to beta-lactam therapy (i.e. severe allergy, severe adverse drug reaction)
  • Expected death before 5 days
  • Microbiologically confirmed need for concomitant VANCOMYCIN or DAPTOMYCIN
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02972983
Other Study ID Numbers  ICMJE 2017-2666
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: We will make this available under the right conditions including the appropriate data sharing agreements and ethics applications under Quebec law.
Responsible Party Todd Lee, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Todd C Lee, MD McGill University Health Centre/Research Institute of the McGill University Health Centre
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date September 2020

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