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Combination Antibiotic Therapy for Methicillin Resistant Staphylococcus Aureus Infection

NCT02365493 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2018-12-19

No results posted yet for this study

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.

Conditions

  • Methicillin-Resistant Staphylococcus Aureus

Interventions

DRUG

Beta-Lactam

Sponsors & Collaborators

  • Australasian Society for Infectious Diseases

    collaborator OTHER

  • Singapore Infectious Diseases Clinical Research Network

    collaborator OTHER

  • The University of Queensland

    collaborator OTHER

  • Australasian Kidney Trials Network

    collaborator NETWORK

  • Menzies School of Health Research

    lead OTHER

Principal Investigators

  • Joshua Davis, MBBS, FRACP · Menzies School of Health Research

  • Steven Tong, MBBS, FRACP · Menzies School of Health Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-26
Primary Completion
2018-10-24
Completion
2018-10-24

Countries

  • Australia
  • Israel
  • New Zealand
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02365493 on ClinicalTrials.gov