Combination Antibiotic Therapy for Methicillin Resistant Staphylococcus Aureus Infection
Status:
Terminated
Trial end date:
2018-10-24
Target enrollment:
Participant gender:
Summary
The aim of this clinical trial is to determine whether a novel combination antibiotic
treatment (vancomycin/daptomycin + beta-lactam) is superior to the standard antibiotic
treatment (vancomycin/daptomycin) for hospitalised adults with Methicillin Resistant
Staphylococcus aureus bacteraemia. The hypothesis is that the addition of beta-lactam
antibiotics (these are antibiotics from the penicillin family) to the standard therapy will
lead to more efficient bacterial killing and hence lead to faster clearance of bacteria from
the blood stream and other areas of infection, thereby reducing the risk of the spread of
infection and death.
The study design is an investigator-initiated, multi-centre, open-label, randomised
controlled trial. This will include 440 participants diagnosed with Methicillin Resistant
Staphylococcus aureus bacteraemia recruited over a period of 4 years (July 2015 - June 2019)
from within Infectious Diseases inpatient units across 21 hospital sites including 18 from
within Australia and 3 located in Singapore. Participation will be voluntary and subject to
informed consent. The participants will be randomised 1:1 to either the standard therapy
group or combination therapy group. The combination therapy will include a treatment of
intravenous beta-lactam for the first 7 days of treatment, in addition to the standard
treatment (either vancomycin or daptomycin). The primary outcome measure will be
complication-free survival 90 days post randomisation.
Phase:
Phase 3
Details
Lead Sponsor:
Menzies School of Health Research
Collaborators:
Australasian Kidney Trials Network Australasian Society for Infectious Diseases Singapore Infectious Diseases Clinical Research Network The University of Queensland