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Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia (DASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02972983
Recruitment Status : Completed
First Posted : November 25, 2016
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Todd Lee, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Condition or disease Intervention/treatment Phase
Methicillin Susceptible Staphylococcus Aureus Septicemia Bacteremia Drug: Daptomycin Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : July 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other: Placebo
Placebo

Experimental: Daptomycin
51 patients receiving daily daptomycin infusion for five days on top of standard of care treatment for MSSA bacteremia
Drug: Daptomycin
Adjuvant therapy for up to five days
Other Name: Cubicin




Primary Outcome Measures :
  1. Blood culture clearance [ Time Frame: 5 days ]
    Time between first positive and first negative blood culture


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    Death from all causes (yes/no)

  2. Adverse Reactions [ Time Frame: 5 days ]
    Daptomycin adverse reactions

  3. Intensive care admission [ Time Frame: 30 days ]
    Admission to the intensive care unit (yes/no)

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02972983


Locations
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Canada, Quebec
McGill University Health Centre (Royal Victoria Hospital, Montreal Neurological Hospital, and Montreal General Hospital)
Montreal, Quebec, Canada, H4A3J1
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Todd C Lee, MD McGill University Health Centre/Research Institute of the McGill University Health Centre
Publications:
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Responsible Party: Todd Lee, Doctor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02972983    
Other Study ID Numbers: 2017-2666
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
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.
Keywords provided by Todd Lee, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Staphylococcus aureus
Bacteremia
Daptomycin
Additional relevant MeSH terms:
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Bacteremia
Sepsis
Bacterial Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents