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NCT Number: NCT06637332

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)

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Blacktown Hospital, Blacktown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daptomycin for Injection

Drug

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

Primary outcomes

  1. 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:

    • 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

Secondary outcomes

  1. 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.

  2. 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

  3. All cause mortality

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

    Death from any cause

  4. 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.

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lina Petrella

CONTACT

[email protected]

514-934-1934 ext. 23730

Sponsors and collaborators

Lead sponsor

Todd C. Lee MD MPH FIDSA

Other

Collaborators

  • The Peter Doherty Institute for Infection and Immunity
  • University of Melbourne

Registry information

Official study title

DAPTO-SNAP: Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia

Acronym: DAPTO-SNAP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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