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Completed

NCT Number: NCT02972983

Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

McGill University Health Centre (Royal Victoria Hospital, Montreal Neurological Hospital, and Montreal General Hospital)

Montreal, Quebec, H4A3J1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

daptomycin

Drug

Adjuvant therapy for up to five days

Other names: Cubicin

Placebo

Other

Placebo

Primary outcomes

  1. Blood culture clearance

    Time frame: 5 days

    Time between first positive and first negative blood culture

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Acronym: DASH

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 25, 2016
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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