Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia

NCT06637332 | Recruiting Phase 4 DMC

• 2 other identifiers: 2025-10666466322
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 14

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)

Conditions

Staphylococcus Aureus Bacteremia; S. Aureus Bacteremia; S. Aureus Bloodstream Infection; Staphylococcus Aureus Endocarditis; Staphylococcus Aureus Septicemia

Keywords

S. aureus bacteremia; Methicllin resistant; MRSA; S. aureus bloodstream infection; Daptomycin; Vancomycin

Outcome Measures

Primary Outcomes (1)

• 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: 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

  Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

Secondary Outcomes (6)

• Clinical failure

  Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

• Serious Adverse Event or Adverse Event Leading to Discontinuation

  Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

• All cause mortality

  Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

• Infectious Complications

  Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

• Drug Induced Myostitis

  Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)

Study Arms (2)

Daptomycin

EXPERIMENTAL

Daptomycin given by injection at a dose determined by the treating clinicians but no less than 6mg/kg

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

Drug: Vancomycin (IV)

Interventions

Daptomycin for Injection DRUG

Daptomycin given by injection at a dose determined by the treating team but not to be less than 6mg/kg

Daptomycin

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

Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Methicillin-resistant S. aureus bacteremia
• 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

Sponsors & Collaborators

• University of Melbourne: collaborator
• The Peter Doherty Institute for Infection and Immunity: collaborator
• Todd C. Lee MD MPH FIDSA: lead

Study Sites (14)

Concord Repatriation and General Hospital

Concord, New South Wales, 2139, Australia

RECRUITING

John Hunter Hospital

Newcastle, New South Wales, 2305, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

RECRUITING

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

RECRUITING

Monash Medical Campus (Monash Medical Centre + Jesse McPherson Private Hospital)

Clayton, Victoria, 3168, Australia

RECRUITING

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

RECRUITING

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

RECRUITING

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

RECRUITING

Fraser Health Authority (Surrey Memorial Hospital)

Surrey, British Columbia, V3V1Z2, Canada

RECRUITING

Newfoundland Health Services (Health Sciences Centre and St. Clare's Mercy Hospital)

St. John's, Newfoundland and Labrador, Canada

RECRUITING

Hamilton Health Sciences (Hamilton General Hospital and Juravinski Hospital)

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

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

Montreal, Quebec, H4A3S1, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 37543121 BACKGROUND

• 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.

  PMID: 16914701 BACKGROUND

MeSH Terms

Interventions

Daptomycin; Injections; Vancomycin

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Drug Administration Routes; Drug Therapy; Therapeutics; Glycopeptides; Glycoconjugates; Carbohydrates

Study Officials

• Todd C Lee, MD MPH FIDSA

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lina Petrella

CONTACT

514-934-1934; lina.petrella@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2025-08

Locations

AU (10); CA (4)