<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02972983</url>
  </required_header>
  <id_info>
    <org_study_id>2017-2666</org_study_id>
    <nct_id>NCT02972983</nct_id>
  </id_info>
  <brief_title>Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia</brief_title>
  <acronym>DASH</acronym>
  <official_title>Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of our study is to examine the effects of a second antibiotic, daptomycin, in&#xD;
      combination with a beta lactam antibiotic on treating bloodstream infection caused by&#xD;
      methicillin-susceptible S. aureus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When patients have a blood infection with methicillin-susceptible S. aureus, they will all be&#xD;
      treated with the usual standard of care, including abeta-lactam antibiotic, have their blood&#xD;
      tested daily for the presence of the infection until they test negative, as well as an&#xD;
      ultrasound of the heart to rule out an infection of the heart valves, as well as have any&#xD;
      catheters removed (if possible) to ensure adequate control of the infection.&#xD;
&#xD;
      This study involves adding a second antibiotic, daptomycin, to the treatment regimen of half&#xD;
      of the patients enrolled in this study. Daptomycin is approved by Health Canada for treating&#xD;
      blood infections due to Staphylococcus aureus. It is currently not used in combination with a&#xD;
      beta-lactam for these infections because there is insufficient evidence of benefit to justify&#xD;
      the cost.&#xD;
&#xD;
      The study participants will receive an additional daily iv therapy which will consist of&#xD;
      either daptomycin or a placebo for a total of five days while admitted to the hospital.&#xD;
      During this time, the participants will continue to have their blood drawn to assess for the&#xD;
      presence of bacteria. The participants' liver and muscle enzymes will also be measured on the&#xD;
      first and fifth day of therapy to test for potential side effects of the daptomycin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">July 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood culture clearance</measure>
    <time_frame>5 days</time_frame>
    <description>Time between first positive and first negative blood culture</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Death from all causes (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Reactions</measure>
    <time_frame>5 days</time_frame>
    <description>Daptomycin adverse reactions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care admission</measure>
    <time_frame>30 days</time_frame>
    <description>Admission to the intensive care unit (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metastatic infection</measure>
    <time_frame>30 days</time_frame>
    <description>The development of a new deep seated infection (e.g. osteomyelitis, abscess, endocarditis) not present at time of initial bacteremia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrent infection</measure>
    <time_frame>30 days</time_frame>
    <description>The presence of a new positive blood culture occurring after the first negative culture and within 30 days of the initial positive</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Methicillin Susceptible Staphylococcus Aureus Septicemia</condition>
  <condition>Bacteremia</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>51 patients receiving a daily placebo infusion for five days on top of standard of care treatment for methicillin-sensitive Staphylococcus aureus (MSSA) bacteremia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Daptomycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>51 patients receiving daily daptomycin infusion for five days on top of standard of care treatment for MSSA bacteremia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daptomycin</intervention_name>
    <description>Adjuvant therapy for up to five days</description>
    <arm_group_label>Daptomycin</arm_group_label>
    <other_name>Cubicin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has a methicillin susceptible Staphylococcus aureus bacteremia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Underlying terminal illness&#xD;
&#xD;
          -  Significant contraindication to beta-lactam therapy (i.e. severe allergy, severe&#xD;
             adverse drug reaction)&#xD;
&#xD;
          -  Expected death before 5 days&#xD;
&#xD;
          -  Microbiologically confirmed need for concomitant VANCOMYCIN or DAPTOMYCIN&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd C Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McGill University Health Centre (Royal Victoria Hospital, Montreal Neurological Hospital, and Montreal General Hospital)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Cheng MP, Lawandi A, Butler-Laporte G, Paquette K, Lee TC. Daptomycin versus placebo as an adjunct to beta-lactam therapy in the treatment of Staphylococcus aureus bacteremia: study protocol for a randomized controlled trial. Trials. 2018 May 29;19(1):297. doi: 10.1186/s13063-018-2668-6.</citation>
    <PMID>29843781</PMID>
  </reference>
  <reference>
    <citation>Cheng MP, Lawandi A, Butler-Laporte G, De l'Etoile-Morel S, Paquette K, Lee TC. Adjunctive Daptomycin in the Treatment of Methicillin-susceptible Staphylococcus aureus Bacteremia: A Randomized, Controlled Trial. Clin Infect Dis. 2021 May 4;72(9):e196-e203. doi: 10.1093/cid/ciaa1000.</citation>
    <PMID>32667982</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>September 18, 2020</last_update_submitted>
  <last_update_submitted_qc>September 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Todd Lee</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Staphylococcus aureus</keyword>
  <keyword>Bacteremia</keyword>
  <keyword>Daptomycin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Staphylococcal Infections</mesh_term>
    <mesh_term>Bacteremia</mesh_term>
    <mesh_term>Sepsis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Daptomycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We will make this available under the right conditions including the appropriate data sharing agreements and ethics applications under Quebec law.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02972983
org study id: 2017-2666
nct id: NCT02972983
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Blood culture clearance
time frame: 5 days
description: Time between first positive and first negative blood culture
measure: Mortality
time frame: 30 days
description: Death from all causes (yes/no)
measure: Adverse Reactions
time frame: 5 days
description: Daptomycin adverse reactions
measure: Intensive care admission
time frame: 30 days
description: Admission to the intensive care unit (yes/no)
measure: Metastatic infection
time frame: 30 days
description: The development of a new deep seated infection (e.g. osteomyelitis, abscess, endocarditis) not present at time of initial bacteremia
measure: Recurrent infection
time frame: 30 days
description: The presence of a new positive blood culture occurring after the first negative culture and within 30 days of the initial positive
arm group label: Placebo
arm group type: Placebo Comparator
description: 51 patients receiving a daily placebo infusion for five days on top of standard of care treatment for methicillin-sensitive Staphylococcus aureus (MSSA) bacteremia
arm group label: Daptomycin
arm group type: Experimental
description: 51 patients receiving daily daptomycin infusion for five days on top of standard of care treatment for MSSA bacteremia
intervention type: Drug
intervention name: Daptomycin
description: Adjuvant therapy for up to five days
arm group label: Daptomycin
other name: Cubicin
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Todd C Lee, MD
role: Principal Investigator
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
facility: 
country: Canada
citation: Cheng MP, Lawandi A, Butler-Laporte G, Paquette K, Lee TC. Daptomycin versus placebo as an adjunct to beta-lactam therapy in the treatment of Staphylococcus aureus bacteremia: study protocol for a randomized controlled trial. Trials. 2018 May 29;19(1):297. doi: 10.1186/s13063-018-2668-6.
PMID: 29843781
citation: Cheng MP, Lawandi A, Butler-Laporte G, De l'Etoile-Morel S, Paquette K, Lee TC. Adjunctive Daptomycin in the Treatment of Methicillin-susceptible Staphylococcus aureus Bacteremia: A Randomized, Controlled Trial. Clin Infect Dis. 2021 May 4;72(9):e196-e203. doi: 10.1093/cid/ciaa1000.
PMID: 32667982
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Todd Lee
investigator title: Doctor
mesh term: Staphylococcal Infections
mesh term: Bacteremia
mesh term: Sepsis
mesh term: Daptomycin
sharing ipd: Undecided
ipd description: We will make this available under the right conditions including the appropriate data sharing agreements and ethics applications under Quebec law.