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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Daptomycin given by injection at a dose determined by the treating team but not to be less than 6mg/kg
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
Concord Repatriation and General Hospital
Concord, New South Wales, Australia
RECRUITINGJohn Hunter Hospital
Newcastle, New South Wales, Australia
NOT_YET_RECRUITINGWestmead Hospital
Westmead, New South Wales, Australia
RECRUITINGRoyal Brisbane and Women's Hospital
Herston, Queensland, Australia
RECRUITINGFlinders Medical Centre
Bedford Park, South Australia, Australia
NOT_YET_RECRUITINGBox Hill Hospital
Box Hill, Victoria, Australia
RECRUITINGMonash Medical Campus (Monash Medical Centre + Jesse McPherson Private Hospital)
Clayton, Victoria, Australia
RECRUITINGRoyal Melbourne Hospital
Parkville, Victoria, Australia
RECRUITINGFiona Stanley Hospital
Murdoch, Western Australia, Australia
NOT_YET_RECRUITINGRoyal Perth Hospital
Perth, Western Australia, Australia
NOT_YET_RECRUITING...and 3 more locations
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
Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
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.
Time frame: 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
Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
All cause mortality
Death from any cause
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)
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