Daptomycin Vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia

Phase 4

Recruiting

• Conditions: Staphylococcus Aureus Septicemia; Staphylococcus Aureus Bacteremia; S. Aureus Bacteremia; S. Aureus Bloodstream Infection; Staphylococcus Aureus Endocarditis
• Interventions: Drug: Daptomycin for Injection; Drug: Vancomycin (IV)

• Registration Number: NCT06637332
• Lead Sponsor: Todd C. Lee MD MPH FIDSA

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Status Verified: 2024-11
• Study Start: 2024-11-14
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2027-01
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daptomycin	Daptomycin for Injection	Daptomycin given by injection at a dose determined by the treating clinicians but no less than 6mg/kg
Vancomycin	Vancomycin (IV)	Vancomycin given by injection at a dose determined by the treating clinicians to achieve a trough-based or AUC-based target

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Fraser Health Authority (Surrey Memorial Hospital); 🇨🇦 Surrey, British Columbia, Canada

McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital); 🇨🇦 Montreal, Quebec, Canada