Staphylococcus Aureus SepticemiaPhase 4DAPTO-SNAPNCT06637332
Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia
A Phase 4 study testing Daptomycin for Injection and Vancomycin (IV) in people with Staphylococcus Aureus Septicemia and Staphylococcus Aureus Bacteremia, run by Todd C. Lee MD MPH FIDSA at 20 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus Septicemia, Staphylococcus Aureus Bacteremia, S. Aureus Bacteremia
- What is being tested?
- Daptomycin for Injection and Vancomycin (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 14 Nov 2024to Nov 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Methicillin-resistant S. aureus bacteremia
Who cannot join
- 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
Trial locations and contacts
20 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 3 countries
Australia12 sites, 12 recruiting
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
Nicholas Anagnostou, MD, nicholas.anagnostou@sa.gov.au
Nicholas Anagnostou, MD
- Recruiting
Monash Health - Casey Hospital
Berwick, Victoria, 3806
Ben Rogers, MD, Ben.rogers@monash.edu
Ben Rogers, MD
- Recruiting
Blacktown Hospital
Blacktown, New South Wales, NSW 2148
Ravindra Dotel, MD, Ravindra.dotel@health.nsw.gov.au
Ravindra Dotel, MD
- Recruiting
Box Hill Hospital
Box Hill, Victoria, 3128
Stephen Guy, MD, stephen.guy@easternhealth.org.au
Steven Guy, MD
- Recruiting
Monash Medical Campus (Monash Medical Centre + Jesse McPherson Private Hospital)
Clayton, Victoria, 3168
Ben Rogers, MD PhD, ben.rogers@monash.edu
Ben Rogers, MD PhD
- Recruiting
Concord Repatriation and General Hospital
Concord, New South Wales, 2139
Genevieve McKew, genevieve.mckew@health.nsw.gov, genevieve.mckew@health.nsw.gov.au
Genevieve McKew
- Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Bridget Barber, MD, Bridget.Barber@qimrberghofer.edu.au
Bridget Barber, MD
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Owen Robinson, MD, owen.robinson@health.wa.gov.au
Owen Robinson, MD
- Recruiting
John Hunter Hospital
Newcastle, New South Wales, 2305
Brian Chong, MD PhD, brian.chong@health.nsw.gov.au
Joshua Davis, MD PhD
- Recruiting
Royal Melbourne Hospital
Parkville, Victoria, 3050
Justin Denholm, MD, justin.denholm@mh.org.au
Justin Denholm, MD
- Recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
Owen Robinson, MD, owen.robinson@health.wa.gov.au
Owen Robinson, MD
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Matthew O'Sullivan, MD, matthew.osullivan@health.nsw.gov.au
Matthew O'Sullivan, MD
Canada7 sites, 7 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta
Stephanie Smith, MD, ss@ualberta.ca
Stephanie Smith, MD
- Recruiting
Hamilton Health Sciences (Hamilton General Hospital and Juravinski Hospital)
Hamilton, Ontario, L8L 2X2
Dominik Mertz, MD, 905-521-2100 ext. 43592, mertzd@mcmaster.ca
Dominik Mertz, MD
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Leighanne Parkes, MD, leighanne.parkes@mcgill.ca
Leighanne Parkes, MD
- Recruiting
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
Montreal, Quebec, H4A3S1
Lina Petrella, 5149341934 ext. 23730, lina.petrella@muhc.mcgill.ca
Todd C Lee, MD MPH FIDSA
- Recruiting
Newfoundland Health Services (Health Sciences Centre and St. Clare's Mercy Hospital)
St. John's, Newfoundland and Labrador
Peter Daly, MD, pkd336@mun.ca
Peter Daly, MD
- Recruiting
Fraser Health Authority (Surrey Memorial Hospital)
Surrey, British Columbia, V3V1Z2
Christopher Condin, PhD, christopher.condin@fraserhealth.ca
Kevin Afra, MD
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Nick Daneman, MD MSc, Nick.Daneman@sunnybrook.ca
Nick Daneman, MD MSc
New Zealand1 site, 1 recruiting
- Recruiting
Middlemore Hospital
Otahuhu, Auckland
Georgia Fowler, Georgia.Fowler@aotearoatrials.nz
Genevieve Walls, MD
About this study
Official title: 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)
- Conditions
- Staphylococcus Aureus Septicemia, Staphylococcus Aureus Bacteremia, S. Aureus Bacteremia, S. Aureus Bloodstream Infection, Staphylococcus Aureus Endocarditis
- Being tested
- Daptomycin for Injection, Vancomycin (IV)
- Keywords
- S. aureus bacteremia, Methicllin resistant, MRSA, S. aureus bloodstream infection, Daptomycin, Vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daptomycin for InjectionDrug
Daptomycin given by injection at a dose determined by the treating team but not to be less than 6mg/kg
Vancomycin (IV)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Daptomycin | Experimental | Daptomycin given by injection at a dose determined by the treating clinicians but no less than 6mg/kg Receives: Drug: Daptomycin for Injection |
| Vancomycin | Active comparator | Vancomycin given by injection at a dose determined by the treating clinicians to achieve a trough-based or AUC-based target Receives: Drug: Vancomycin (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desirability of Outcome Ranking (DOOR)
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:
- Clinical failure: Absence of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated.
- 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.
- 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
Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Secondary outcomes (6)
Clinical failure
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.
Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Serious Adverse Event or Adverse Event Leading to Discontinuation
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
Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
All cause mortality
Death from any cause
Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Infectious Complications
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.
Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Drug Induced Myostitis
Defined as a creatinine kinase level greater than or equal to 5 times the upper limit of normal
Measured: Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)
Eosinophilic pneumonia
Defined as the development of symptomatic eosinophilic pneumonia as diagnosed by the treating team in consultation with the appropriate specialists
Measured: Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start14 Nov 2024
- Primary completionJan 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus Aureus SepticemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Todd C. Lee MD MPH FIDSA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne, The Peter Doherty Institute for Infection and Immunity
- Responsible party
- Sponsor-investigator, Todd C. Lee MD MPH FIDSA, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Todd C Lee, MD MPH FIDSA, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637332
- Sponsor's protocol ID
- 2025-10666
- Other IDs
- 466322, 2025
- Acronym
- DAPTO-SNAP
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing policies are dependent on the policies of the SNAP Platform (NCT05137119)
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.
PubMed 37543121Fowler 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.
PubMed 16914701