- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06637332
Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia (DAPTO-SNAP)
DAPTO-SNAP: Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia
This is an open label randomized controlled trial for patients with methicillin resistant S. aureus (MRSA) bloodstream infection which will directly compare the two most commonly used therapies, vancomycin and daptomycin.
This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Lina Petrella
- Phone Number: 23730 514-934-1934
- Email: lina.petrella@muhc.mcgill.ca
Study Locations
-
-
New South Wales
-
Concord, New South Wales, Australia, 2139
- Recruiting
- Concord Repatriation and General Hospital
-
Principal Investigator:
- Genevieve McKew
-
Contact:
- Genevieve McKew, genevieve.mckew@health.nsw.gov
- Email: genevieve.mckew@health.nsw.gov.au
-
Newcastle, New South Wales, Australia, 2305
- Recruiting
- John Hunter Hospital
-
Principal Investigator:
- Joshua Davis, MD PhD
-
Contact:
- Brian Chong, MD PhD
- Email: brian.chong@health.nsw.gov.au
-
Westmead, New South Wales, Australia, 2145
- Recruiting
- Westmead Hospital
-
Contact:
- Matthew O'Sullivan, MD
- Email: matthew.osullivan@health.nsw.gov.au
-
Principal Investigator:
- Matthew O'Sullivan, MD
-
-
Queensland
-
Herston, Queensland, Australia, 4029
- Recruiting
- Royal Brisbane and Women's Hospital
-
Contact:
- Bridget Barber, MD
- Email: Bridget.Barber@qimrberghofer.edu.au
-
Principal Investigator:
- Bridget Barber, MD
-
-
South Australia
-
Bedford Park, South Australia, Australia, 5042
- Recruiting
- Flinders Medical Centre
-
Contact:
- Nicholas Anagnostou, MD
- Email: nicholas.anagnostou@sa.gov.au
-
Principal Investigator:
- Nicholas Anagnostou, MD
-
-
Victoria
-
Box Hill, Victoria, Australia, 3128
- Recruiting
- Box Hill Hospital
-
Contact:
- Stephen Guy, MD
- Email: stephen.guy@easternhealth.org.au
-
Principal Investigator:
- Steven Guy, MD
-
Clayton, Victoria, Australia, 3168
- Recruiting
- Monash Medical Campus (Monash Medical Centre + Jesse McPherson Private Hospital)
-
Contact:
- Ben Rogers, MD PhD
- Email: ben.rogers@monash.edu
-
Principal Investigator:
- Ben Rogers, MD PhD
-
Parkville, Victoria, Australia, 3050
- Recruiting
- Royal Melbourne Hospital
-
Contact:
- Justin Denholm, MD
- Email: justin.denholm@mh.org.au
-
Principal Investigator:
- Justin Denholm, MD
-
-
Western Australia
-
Murdoch, Western Australia, Australia, 6150
- Recruiting
- Fiona Stanley Hospital
-
Contact:
- Owen Robinson, MD
- Email: owen.robinson@health.wa.gov.au
-
Principal Investigator:
- Owen Robinson, MD
-
Perth, Western Australia, Australia, 6000
- Recruiting
- Royal Perth Hospital
-
Contact:
- Owen Robinson, MD
- Email: owen.robinson@health.wa.gov.au
-
Principal Investigator:
- Owen Robinson, MD
-
-
-
-
Alberta
-
Edmonton, Alberta, Canada
- Recruiting
- University of Alberta Hospital
-
Principal Investigator:
- Stephanie Smith, MD
-
Contact:
- Stephanie Smith, MD
- Email: ss@ualberta.ca
-
-
British Columbia
-
Surrey, British Columbia, Canada, V3V1Z2
- Recruiting
- Fraser Health Authority (Surrey Memorial Hospital)
-
Principal Investigator:
- Kevin Afra, MD
-
Contact:
- Christopher Condin, PhD
- Email: christopher.condin@fraserhealth.ca
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Canada
- Recruiting
- Newfoundland Health Services (Health Sciences Centre and St. Clare's Mercy Hospital)
-
Contact:
- Peter Daly, MD
- Email: pkd336@mun.ca
-
Principal Investigator:
- Peter Daly, MD
-
-
Ontario
-
Hamilton, Ontario, Canada, L8L 2X2
- Recruiting
- Hamilton Health Sciences (Hamilton General Hospital and Juravinski Hospital)
-
Principal Investigator:
- Dominik Mertz, MD
-
Contact:
- Dominik Mertz, MD
- Phone Number: 43592 905-521-2100
- Email: mertzd@mcmaster.ca
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Recruiting
- Jewish General Hospital
-
Contact:
- Leighanne Parkes, MD
- Email: leighanne.parkes@mcgill.ca
-
Principal Investigator:
- Leighanne Parkes, MD
-
Montreal, Quebec, Canada, H4A3S1
- Recruiting
- McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
-
Principal Investigator:
- Emily G McDonald, MD MSc
-
Principal Investigator:
- Todd C Lee, MD MPH FIDSA
-
Contact:
- Lina Petrella
- Phone Number: 23730 5149341934
- Email: lina.petrella@muhc.mcgill.ca
-
Sub-Investigator:
- Matthew P. Cheng, MD SM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria:
Inclusion Criteria:
- Methicillin-resistant S. aureus bacteremia
Exclusion Criteria:
- Severe allergy or non-severe rash to vancomycin or daptomycin
- Suspected or confirmed MRSA pneumonia
- Known vancomycin minimum inhibitory concentration (MIC) greater than or equal to 2mg/L or daptomycin MIC greater than or equal to 1mg/L
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Daptomycin
Daptomycin given by injection at a dose determined by the treating clinicians but no less than 6mg/kg
|
Daptomycin given by injection at a dose determined by the treating team but not to be less than 6mg/kg
|
|
Active Comparator: Vancomycin
Vancomycin given by injection at a dose determined by the treating clinicians to achieve a trough-based or AUC-based target
|
Vancomycin by injection to be given at a dose selected by the treating team to achieve a desired trough level or AUC-based target, as determined by local standards of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Desirability of Outcome Ranking (DOOR)
Time Frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
|
Desirability of Outcome Ranking (DOOR) - an ordinal outcome with 5 levels defined: Rank 1 - Alive without complication Rank 2 - Alive with 1 complication Rank 3 - Alive with 2 complications Rank 4 - Alive with 3 complications Rank 5 - Dead Complications include:
|
Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical failure
Time Frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
|
Defined as the absence of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated for its treatment.
|
Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
|
|
Serious Adverse Event or Adverse Event Leading to Discontinuation
Time Frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
|
Defined as a serious adverse drug event (Common Terminology Criteria for Adverse Events (CTCAE) class 4) presumed due to study drug OR adverse drug event (CTCAE classes 1-3) leading to discontinuation of the study drug
|
Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
|
|
All cause mortality
Time Frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
|
Death from any cause
|
Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
|
|
Infectious Complications
Time Frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
|
Defined as change in therapy for inadequate clinical response; new endocarditis; new evidence of other deep metastatic foci (e.g., osteomyelitis or deep abscess); relapse of MRSA bacteremia after a patient has sterilized their initial blood cultures; readmission for subsequent care of S. aureus bacteremia; need for unplanned source control procedures; change of antibiotic therapy due to inadequate clinical response. New implies that the complication was not suspected at enrollment and is not a function of delay to diagnostic testing. |
Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
|
|
Drug Induced Myostitis
Time Frame: Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)
|
Defined as a creatinine kinase level greater than or equal to 5 times the upper limit of normal
|
Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)
|
|
Eosinophilic pneumonia
Time Frame: Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)
|
Defined as the development of symptomatic eosinophilic pneumonia as diagnosed by the treating team in consultation with the appropriate specialists
|
Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Todd C Lee, MD MPH FIDSA, McGill University Health Centre/Research Institute of the McGill University Health Centre
Publications and helpful links
General Publications
- Zhang G, Zhang N, Xu J, Yang T, Yin H, Cai Y. Efficacy and safety of vancomycin for the treatment of Staphylococcus aureus bacteraemia: a systematic review and meta-analysis. Int J Antimicrob Agents. 2023 Oct;62(4):106946. doi: 10.1016/j.ijantimicag.2023.106946. Epub 2023 Aug 4.
- Fowler VG Jr, Boucher HW, Corey GR, Abrutyn E, Karchmer AW, Rupp ME, Levine DP, Chambers HF, Tally FP, Vigliani GA, Cabell CH, Link AS, DeMeyer I, Filler SG, Zervos M, Cook P, Parsonnet J, Bernstein JM, Price CS, Forrest GN, Fatkenheuer G, Gareca M, Rehm SJ, Brodt HR, Tice A, Cosgrove SE; S. aureus Endocarditis and Bacteremia Study Group. Daptomycin versus standard therapy for bacteremia and endocarditis caused by Staphylococcus aureus. N Engl J Med. 2006 Aug 17;355(7):653-65. doi: 10.1056/NEJMoa053783.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Gram-Positive Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Staphylococcal Infections
- Bacteremia
- Sepsis
- Endocarditis
- Peptides
- Amino Acids, Peptides, and Proteins
- Therapeutics
- Lipids
- Drug Administration Routes
- Drug Therapy
- Carbohydrates
- Polycyclic Compounds
- Glycoconjugates
- Macrocyclic Compounds
- Peptides, Cyclic
- Lipopeptides
- Glycopeptides
- Vancomycin
- Daptomycin
- Injections
Other Study ID Numbers
- 2025-10666
- 466322 (Other Grant/Funding Number: Canadian Institutes of Health Research)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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