S. Aureus Bacteremia, S. Aureus Bloodstream Infection, Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis, Staphylococcus Aureus Septicemia
Conditions
Keywords
S. aureus bacteremia, Methicllin resistant, MRSA, S. aureus bloodstream infection, Daptomycin, Vancomycin
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)
Interventions
Daptomycin given by injection at a dose determined by the treating team but not to be less than 6mg/kg
DRUGVancomycin (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
Sponsors
Todd C. Lee MD MPH FIDSA
University of Melbourne
The Peter Doherty Institute for Infection and Immunity
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The participant must meet all inclusion and
Exclusion criteria
for the SNAP Platform (NCT05137119) and also the following inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Desirability of Outcome Ranking (DOOR) | 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: 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical failure | 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. |
| Serious Adverse Event or Adverse Event Leading to Discontinuation | 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 |
| All cause mortality | Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119) | Death from any cause |
| Infectious Complications | 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. |
| Drug Induced Myostitis | 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 |
| Eosinophilic pneumonia | 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 |
Countries
Australia, Canada, New Zealand
Contacts
CONTACTLina Petrella
PRINCIPAL_INVESTIGATORTodd C Lee, MD MPH FIDSA
McGill University Health Centre/Research Institute of the McGill University Health Centre
Outcome results
None listed