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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06637332
Registration number
NCT06637332
Ethics application status
Date submitted
9/10/2024
Date registered
15/10/2024
Date last updated
15/08/2025
Titles & IDs
Public title
Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia
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Scientific title
DAPTO-SNAP: Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia
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Secondary ID [1]
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466322
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Secondary ID [2]
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2025-10666
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Universal Trial Number (UTN)
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Trial acronym
DAPTO-SNAP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Staphylococcus Aureus Septicemia
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Staphylococcus Aureus Bacteremia
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S. Aureus Bacteremia
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S. Aureus Bloodstream Infection
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Staphylococcus Aureus Endocarditis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Daptomycin for Injection
Treatment: Drugs - Vancomycin (IV)
Experimental: Daptomycin - Daptomycin given by injection at a dose determined by the treating clinicians but no 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
Treatment: Drugs: Daptomycin for Injection
Daptomycin given by injection at a dose determined by the treating team but not to be less than 6mg/kg
Treatment: Drugs: Vancomycin (IV)
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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Desirability of Outcome Ranking (DOOR)
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Assessment method [1]
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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: 1. Clinical failure: Absence of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated. 2. Infectious Complications: Including 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 therapy due to inadequate clinical response. 3. Serious adverse drug event (Common Terminology Criteria class 4) due to study drug OR adverse drug event (classes 1-3) leading to discontinuation of the study drug
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Timepoint [1]
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Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
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Secondary outcome [1]
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Clinical failure
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Assessment method [1]
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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.
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Timepoint [1]
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Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
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Secondary outcome [2]
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Serious Adverse Event or Adverse Event Leading to Discontinuation
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Assessment method [2]
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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
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Timepoint [2]
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Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
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Secondary outcome [3]
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All cause mortality
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Assessment method [3]
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Death from any cause
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Timepoint [3]
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Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
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Secondary outcome [4]
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Infectious Complications
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Assessment method [4]
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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.
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Timepoint [4]
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Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
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Secondary outcome [5]
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Drug Induced Myostitis
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Assessment method [5]
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Defined as a creatinine kinase level greater than or equal to 5 times the upper limit of normal
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Timepoint [5]
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Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)
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Secondary outcome [6]
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Eosinophilic pneumonia
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Assessment method [6]
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Defined as the development of symptomatic eosinophilic pneumonia as diagnosed by the treating team in consultation with the appropriate specialists
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Timepoint [6]
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Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)
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Eligibility
Key inclusion criteria
The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria:
* Methicillin-resistant S. aureus bacteremia
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/11/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2027
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation and General Hospital - Concord
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Recruitment hospital [2]
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John Hunter Hospital - Newcastle
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Recruitment hospital [3]
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Westmead Hospital - Westmead
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Recruitment hospital [4]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [5]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [6]
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Box Hill Hospital - Box Hill
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Recruitment hospital [7]
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Monash Medical Campus (Monash Medical Centre + Jesse McPherson Private Hospital) - Clayton
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Recruitment hospital [8]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [9]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [10]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2305 - Newcastle
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4029 - Herston
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Recruitment postcode(s) [5]
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5042 - Bedford Park
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Recruitment postcode(s) [6]
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3128 - Box Hill
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Recruitment postcode(s) [7]
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3168 - Clayton
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Recruitment postcode(s) [8]
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3050 - Parkville
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Recruitment postcode(s) [9]
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6150 - Murdoch
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Recruitment postcode(s) [10]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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British Columbia
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Country [2]
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Canada
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State/province [2]
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Newfoundland and Labrador
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Country [3]
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Canada
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State/province [3]
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
Todd C. Lee MD MPH FIDSA
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Address
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Other collaborator category [1]
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Other
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Name [1]
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University of Melbourne
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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The Peter Doherty Institute for Infection and Immunity
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
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)
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Trial website
https://clinicaltrials.gov/study/NCT06637332
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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Todd C Lee, MD MPH FIDSA
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Address
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McGill University Health Centre/Research Institute of the McGill University Health Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lina Petrella
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Address
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Country
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Phone
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514-934-1934
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
Data sharing policies are dependent on the policies of the SNAP Platform (NCT05137119)
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06637332
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