Combination Antibiotic Therapy for Methicillin Resistant Staphylococcus Aureus Infection
Information source: Menzies School of Health Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Methicillin-Resistant Staphylococcus Aureus
Intervention: Beta-Lactam (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Menzies School of Health Research Official(s) and/or principal investigator(s):
Joshua Davis, MBBS, FRACP, Principal Investigator, Affiliation: Menzies School of Health Research
Steven Tong, MBBS, FRACP, Principal Investigator, Affiliation: Menzies School of Health Research
Overall contact:
Joshua Davis, MBBS, FRACP, Phone: +61488191938, Email: joshua.davis@menzies.edu.au
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 antibitoics 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.
Clinical Details
Official title: CAMERA 2 - Combination Antibiotic Therapy for Methicillin Resistant Staphylococcus Aureus Infection - An Investigator-initiated, Multi-centre, Parallel Group, Open Labelled Randomised Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Complication-free 90 day survival
Secondary outcome: All-cause mortality at days 14, 42 and 90 daysPersistent bacteraemia at day 2 Persistent bacteraemia at day 5 or beyond Acute kidney injury defined as ≥ stage 1 modified RIFLE criteria at any time within the first 7 days, OR new need for renal replacement therapy at any time from days 1 to 90. Excludes participants already on haemodialysis. Microbiological relapse - positive blood culture for MRSA at least 72 hours after a preceding negative culture Microbiological treatment failure. Positive sterile site culture for MRSA at least 14 days after randomisation Duration of intravenous antibiotic treatment Direct health care costs
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age >= 18 years.
2. ≥1 set of blood cultures positive for MRSA
3. Able to be randomized within 72 hours of blood cultures being collected.
4. Likely to remain as inpatient for 7 days following randomization
Exclusion Criteria:
1. Previous type 1 hypersensitivity reaction to ß-lactams
2. Polymicrobial bacteraemia (not counting contaminants)
3. Previous participation in the trial
4. Known pregnancy
5. Current β-lactam antibiotic therapy which cannot be ceased or substituted
6. Participant's primary clinician unwilling to enrol patient
7. Moribund (expected to die in next 48 hours with or without treatment)
8. Treatment limitations which preclude the use of antibiotics Note that we are NOT
planning to exclude participants with renal failure.
Locations and Contacts
Joshua Davis, MBBS, FRACP, Phone: +61488191938, Email: joshua.davis@menzies.edu.au Additional Information
Starting date: August 2015
Last updated: August 13, 2015
|
