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| ID | Type | Description | Link |
|---|---|---|---|
| 466322 | Other Grant/Funding Number | Canadian Institutes of Health Research |
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| Name | Class |
|---|---|
| University of Melbourne | OTHER |
| The Peter Doherty Institute for Infection and Immunity | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daptomycin | Experimental | Daptomycin given by injection at a dose determined by the treating clinicians but no less than 6mg/kg |
|
| Vancomycin | Active Comparator | Vancomycin given by injection at a dose determined by the treating clinicians to achieve a trough-based or AUC-based target |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daptomycin for Injection | Drug | Daptomycin given by injection at a dose determined by the treating team but not to be less than 6mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119) |
| Serious Adverse Event or Adverse Event Leading to Discontinuation |
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The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lina Petrella | Contact | 514-934-1934 | 23730 | lina.petrella@muhc.mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Todd C Lee, MD MPH FIDSA | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concord Repatriation and General Hospital | Recruiting | Concord | New South Wales | 2139 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37543121 | Background | 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. | |
| 16914701 | 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. |
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Data sharing policies are dependent on the policies of the SNAP Platform (NCT05137119)
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| 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 |
|
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 |
| Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119) |
| All cause mortality | Death from any cause | 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. | 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 | 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 | Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119) |
| John Hunter Hospital | Recruiting | Newcastle | New South Wales | 2305 | Australia |
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| Westmead Hospital | Recruiting | Westmead | New South Wales | 2145 | Australia |
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| Royal Brisbane and Women's Hospital | Recruiting | Herston | Queensland | 4029 | Australia |
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| Flinders Medical Centre | Recruiting | Bedford Park | South Australia | 5042 | Australia |
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| Box Hill Hospital | Recruiting | Box Hill | Victoria | 3128 | Australia |
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| Monash Medical Campus (Monash Medical Centre + Jesse McPherson Private Hospital) | Recruiting | Clayton | Victoria | 3168 | Australia |
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| Royal Melbourne Hospital | Recruiting | Parkville | Victoria | 3050 | Australia |
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| Fiona Stanley Hospital | Recruiting | Murdoch | Western Australia | 6150 | Australia |
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| Royal Perth Hospital | Recruiting | Perth | Western Australia | 6000 | Australia |
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| University of Alberta Hospital | Recruiting | Edmonton | Alberta | Canada |
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| Fraser Health Authority (Surrey Memorial Hospital) | Recruiting | Surrey | British Columbia | V3V1Z2 | Canada |
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| Newfoundland Health Services (Health Sciences Centre and St. Clare's Mercy Hospital) | Recruiting | St. John's | Newfoundland and Labrador | Canada |
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| Hamilton Health Sciences (Hamilton General Hospital and Juravinski Hospital) | Recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
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| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
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| McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital) | Recruiting | Montreal | Quebec | H4A3S1 | Canada |
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| D007267 | Injections |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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