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Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia (DASH)

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ClinicalTrials.gov Identifier: NCT02972983
Recruitment Status : Recruiting
First Posted : November 25, 2016
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Todd Lee, McGill University Health Center

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)
Estimated 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
Study Start Date : November 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 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


Contacts
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Contact: Todd C Lee, MD 514-934-1934 ext 53333 todd.lee@mcgill.ca
Contact: Matthew P Cheng, MD 514-934-1934 ext 53333 matthew.cheng@mail.mcgill.ca

Locations
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Canada, Quebec
McGill University Health Centre (Royal Victoria Hospital, Montreal Neurological Hospital, and Montreal General Hospital) Recruiting
Montreal, Quebec, Canada, H4A3J1
Contact: Todd C Lee, MD MPH    514-934-1934 ext 53333    todd.lee@mcgill.ca   
Contact: Cheng P Matthew, MD    514-934-1934 ext 53333    matthew.cheng@mail.mcgill.ca   
Principal Investigator: Todd C Lee, MD MPH         
Principal Investigator: Matthew P Cheng, MD         
Sub-Investigator: Alexander Lawandi, MD         
Sub-Investigator: Guillaume Butler-Laporte, MD         
Sponsors and Collaborators
McGill University Health Center
Investigators
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Principal Investigator: Todd C Lee, MD McGill University Health Center

Publications:
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Responsible Party: Todd Lee, Doctor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02972983     History of Changes
Other Study ID Numbers: 2017-2666
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
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 Center:
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