Clinical trial NCT06637332: Daptomycin Vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia
Official title: DAPTO-SNAP: Daptomycin Vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Staphylococcus Aureus Septicemia
Staphylococcus Aureus Bacteremia
S. Aureus Bacteremia
S. Aureus Bloodstream Infection
Staphylococcus Aureus Endocarditis
Keywords: S. aureus bacteremia
Methicllin resistant
MRSA
S. aureus bloodstream infection
Daptomycin
Vancomycin
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: University of Melbourne
name: The Peter Doherty Institute for Infection and Immunity
First posted: 2024-10-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Desirability of Outcome Ranking (DOOR)
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Secondary outcomes:
measure: Clinical failure
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
measure: Serious Adverse Event or Adverse Event Leading to Discontinuation
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
measure: All cause mortality
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
measure: Infectious Complications
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
measure: Drug Induced Myostitis
timeFrame: Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)
measure: Eosinophilic pneumonia
timeFrame: Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Fraser Health Authority (Surrey Memorial Hospital)
state: British Columbia
city: Montreal
country: Canada
facility: McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Todd C Lee, MD MPH FIDSA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.