Bacteremia Due to Staphylococcus Aureus Clinical Trial
Official title:
A Multi-centre Open Label Randomized Controlled Phase IIB Trial Comparing Vancomycin Versus Daptomycin for the Treatment of MRSA Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations
The aim of this study is to compare the efficacy of daptomycin treatment versus vancomycin
treatment in the treatment of methicillin resistant staphylococcus aureus (MRSA) bloodstream
infections (BSI) due to isolates with high vancomycin minimum inhibitory concentrations
(MIC) (i.e. > or equal to 1.5 ug/ml) in terms of reducing all-cause mortality.
Our secondary aim is to compare clinical failure rates of daptomycin treatment versus
vancomycin treatment and to compare time to microbiological clearance in patients treated
with daptomycin versus those treated with vancomycin.
Our primary hypothesis is that Daptomycin treatment is superior to vancomycin treatment in
reducing mortality from BSIs due to MRSA with high vancomycin MIC from 25% to 10%.
Introduction/Clinical Significance Vancomycin is the standard first-line treatment for
methicillin resistant Staphylococcus aureus (MRSA) bacteremia. In recent years however,
there has been an increase in the number of MRSA isolates with high vancomycin minimum
inhibitory concentrations (MIC). Recent consensus guidelines recommend clinicians consider
using alternative agents such as daptomycin for MRSA infection when the vancomycin MIC is
greater than 1 ug/ml. To date however, there has been no head to head randomized trial
comparing the safety and efficacy of daptomycin and vancomycin in the treatment of blood
stream infections (BSIs) due to MRSA with high vancomycin MICs.
Specific Aims:
Our primary aim is to compare the efficacy of daptomycin treatment versus vancomycin
treatment in the treatment of MRSA BSIs due to isolates with high vancomycin MICs (i.e. > or
equal to 1.5 ug/mL) in terms of reducing all-cause mortality.
Our secondary aim is to compare clinical failure rates of daptomycin treatment versus
vancomycin treatment and to compare time to microbiological clearance in patients treated
with daptomycin versus those treated with vancomycin.
Hypothesis:
Daptomycin treatment is superior to vancomycin treatment in reducing mortality from BSIs due
to MRSA with high vancomycin MIC from 25% to 10%.
Methodology We will conduct a prospective open label randomized controlled phase 2B pilot
study in 3 major Singaporean hospitals, with balanced treatment assignments within each
hospital achieved by permuted block randomization. There will be 21 subjects per arm, with
the control arm receiving vancomycin and the experimental arm receiving daptomycin. The
primary objective is to compare the efficacy of daptomycin treatment versus vancomycin
treatment in the treatment of MRSA BSIs due to isolates with high vancomycin MICs (i.e. > or
equal to 1.5 ug/mL) in terms of reducing all-cause mortality 60 days from positive index
blood culture. Secondary outcomes include rates of clinical failure, time to microbiological
clearance, and rates of nephro- and muscular toxicities in both arms.
If the pilot study proves our hypothesis that indeed , we aim to proceed with a larger scale
trial
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT05329168 -
ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis
|
Phase 2 | |
| Recruiting |
NCT05184764 -
Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
|
Phase 1/Phase 2 |