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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02365493
Registration number
NCT02365493
Ethics application status
Date submitted
11/02/2015
Date registered
19/02/2015
Date last updated
19/12/2018
Titles & IDs
Public title
Combination Antibiotic Therapy for Methicillin Resistant Staphylococcus Aureus Infection
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Scientific title
CAMERA 2 - Combination Antibiotic Therapy for Methicillin Resistant Staphylococcus Aureus Infection - An Investigator-initiated, Multi-centre, Parallel Group, Open Labelled Randomised Controlled Trial
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Secondary ID [1]
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NHMRC1078930
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Universal Trial Number (UTN)
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Trial acronym
CAMERA2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Methicillin-Resistant Staphylococcus Aureus
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Condition category
Condition code
Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
No intervention: Standard therapy - Intravenous vancomycin dosed as per Australian Therapeutic Guidelines (loading dose of 25 mg/kg followed by maintenance dose of 15-20 mg/kg every 12 hours) with subsequent adjustment to maintain trough levels at 15-20 mg/dL OR Intravenous daptomycin 6-10 mg/kg per day, adjusted for renal function (details of renally adjusted dosing provided in full protocol).
The choice of daptomycin or vancomycin is clinician-determined and may be influenced by such factors as local practice, the vancomycin minimum inhibitory concentration (MIC) of the isolate and evidence emerging during the course of the study
Experimental: Standard therapy + Beta-Lactam - In addition to standard treatment an intravenous Beta-Lactam (ß-lactam) will be added for the first 7 calendar days following randomisation (randomisation is day 1 - hence patients will receive 6-7 days of ß-lactam). This ß-lactam will be intravenous flucloxacillin 2g every 6 hours in Australia and intravenous cloxacillin 2g every 6 hours in Singapore. For those with a history of minor allergy to any penicillin (rash or unclear history, but not anaphylaxis or angiooedema), it will be intravenous cefazolin 2g every 8 hours. For haemodialysis patients, it will usually be cefazolin 2g three times per week post dialysis, however clinicians are also free to choose intermittent (flu)cloxacillin, dosed as for glomerular filtration rate (GFR ) \<10, if they desire.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Complication-free 90 day survival
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Assessment method [1]
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Composite outcome at 90 days - any of:
1. All-cause mortality
2. Persistent bacteraemia at day 5 or beyond
3. Microbiological relapse - positive blood culture for MRSA at least 72 hours after a preceding negative culture
4. Microbiological treatment failure. Positive sterile site culture for MRSA at least 14 days after randomisation.
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Timepoint [1]
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Time period from randomisation (day 1) to day 90
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Secondary outcome [1]
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All-cause mortality at days 14, 42 and 90 days
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Assessment method [1]
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Timepoint [1]
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Time period from randomisation (day 1) to day 90
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Secondary outcome [2]
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Persistent bacteraemia at day 2
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Assessment method [2]
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Timepoint [2]
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Time period from randomisation (day 1) to day 90
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Secondary outcome [3]
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Persistent bacteraemia at day 5 or beyond
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Assessment method [3]
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Timepoint [3]
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Time period from randomisation (day 1) to day 90
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Secondary outcome [4]
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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.
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Assessment method [4]
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\>=stage 1 modified RIFLE criteria (1.5-fold increase in the serum creatinine, or glomerular filtration rate (GFR) decrease by 25 percent). This endpoint does not apply to participants who were already on haemodialysis at randomisation.
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Timepoint [4]
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Time period from randomisation (day 1) to day 90
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Secondary outcome [5]
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Microbiological relapse - positive blood culture for MRSA at least 72 hours after a preceding negative culture
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Assessment method [5]
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Timepoint [5]
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Time period from randomisation (day 1) to day 90
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Secondary outcome [6]
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Microbiological treatment failure. Positive sterile site culture for MRSA at least 14 days after randomisation
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Assessment method [6]
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Timepoint [6]
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Time period from randomisation (day 1) to day 90
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Secondary outcome [7]
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Duration of intravenous antibiotic treatment
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Assessment method [7]
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Timepoint [7]
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Time period from randomisation (day 1) to day 90
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Secondary outcome [8]
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Direct health care costs
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Assessment method [8]
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Timepoint [8]
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Time period from randomisation (day 1) to day 90
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 ß-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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/10/2018
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Sample size
Target
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Accrual to date
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Final
358
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Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Blacktown Hospital - Blacktown
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [4]
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St Vincent's Hospital - Darlinghurst
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Recruitment hospital [5]
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Nepean Hospital - Kingswood
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Recruitment hospital [6]
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Liverpool Hospital - Liverpool
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Recruitment hospital [7]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [8]
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Westmead Hospital - Westmead
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Recruitment hospital [9]
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Wollongong Hospital - Wollongong
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Recruitment hospital [10]
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Royal Darwin Hospital - Darwin
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Recruitment hospital [11]
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Cairns Hospital - Cairns
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Recruitment hospital [12]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [13]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [14]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [15]
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Flinder's Medical Centre - Bedford Park
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Recruitment hospital [16]
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The Queen Elizabeth Hospital - Woodville South
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Recruitment hospital [17]
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Monash Medical Centre Clayton Campus - Clayton
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Recruitment hospital [18]
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Dandenong Hospital - Dandenong
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Recruitment hospital [19]
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Western Health - Footscray - Footscray
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Recruitment hospital [20]
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Austin Hospital - Heidelberg
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Recruitment hospital [21]
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Western Health - Sunshine Hospital - Sunshine
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Recruitment hospital [22]
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Western Health - Williamstown Hospital - Williamstown
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Recruitment hospital [23]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [24]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2139 - Concord
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Recruitment postcode(s) [4]
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2010 - Darlinghurst
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Recruitment postcode(s) [5]
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2747 - Kingswood
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Recruitment postcode(s) [6]
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2170 - Liverpool
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Recruitment postcode(s) [7]
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2305 - New Lambton Heights
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Recruitment postcode(s) [8]
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2145 - Westmead
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Recruitment postcode(s) [9]
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2500 - Wollongong
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Recruitment postcode(s) [10]
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0820 - Darwin
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Recruitment postcode(s) [11]
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4870 - Cairns
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Recruitment postcode(s) [12]
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4029 - Herston
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Recruitment postcode(s) [13]
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4102 - Woolloongabba
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Recruitment postcode(s) [14]
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5000 - Adelaide
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Recruitment postcode(s) [15]
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5042 - Bedford Park
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Recruitment postcode(s) [16]
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5011 - Woodville South
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Recruitment postcode(s) [17]
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3168 - Clayton
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Recruitment postcode(s) [18]
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3175 - Dandenong
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Recruitment postcode(s) [19]
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3011 - Footscray
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Recruitment postcode(s) [20]
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3084 - Heidelberg
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Recruitment postcode(s) [21]
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3021 - Sunshine
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Recruitment postcode(s) [22]
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3016 - Williamstown
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Recruitment postcode(s) [23]
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6150 - Murdoch
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Recruitment postcode(s) [24]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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Israel
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State/province [1]
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Haifa
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Israel
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State/province [2]
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Petah Tikva
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New Zealand
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State/province [3]
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Auckland
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Singapore
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State/province [4]
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Tan Tock Seng
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Country [5]
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Singapore
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State/province [5]
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Kent Ridge
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Country [6]
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Singapore
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State/province [6]
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Outram Park
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Funding & Sponsors
Primary sponsor type
Other
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Name
Menzies School of Health Research
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Australasian Society for Infectious Diseases
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Singapore Infectious Diseases Clinical Research Network
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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The University of Queensland
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Australasian Kidney Trials Network
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Address [4]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT02365493
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Trial related presentations / publications
Tong SYC, Lye DC, Yahav D, Sud A, Robinson JO, Nelson J, Archuleta S, Roberts MA, Cass A, Paterson DL, Foo H, Paul M, Guy SD, Tramontana AR, Walls GB, McBride S, Bak N, Ghosh N, Rogers BA, Ralph AP, Davies J, Ferguson PE, Dotel R, McKew GL, Gray TJ, Holmes NE, Smith S, Warner MS, Kalimuddin S, Young BE, Runnegar N, Andresen DN, Anagnostou NA, Johnson SA, Chatfield MD, Cheng AC, Fowler VG Jr, Howden BP, Meagher N, Price DJ, van Hal SJ, O'Sullivan MVN, Davis JS; Australasian Society for Infectious Diseases Clinical Research Network. Effect of Vancomycin or Daptomycin With vs Without an Antistaphylococcal beta-Lactam on Mortality, Bacteremia, Relapse, or Treatment Failure in Patients With MRSA Bacteremia: A Randomized Clinical Trial. JAMA. 2020 Feb 11;323(6):527-537. doi: 10.1001/jama.2020.0103. Tong SY, Nelson J, Paterson DL, Fowler VG Jr, Howden BP, Cheng AC, Chatfield M, Lipman J, Van Hal S, O'Sullivan M, Robinson JO, Yahav D, Lye D, Davis JS; CAMERA2 study group and the Australasian Society for Infectious Diseases Clinical Research Network. CAMERA2 - combination antibiotic therapy for methicillin-resistant Staphylococcus aureus infection: study protocol for a randomised controlled trial. Trials. 2016 Mar 31;17:170. doi: 10.1186/s13063-016-1295-3.
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Public notes
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Contacts
Principal investigator
Name
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Joshua Davis, MBBS, FRACP
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Address
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Menzies School of Health Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02365493
Download to PDF