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Trial registered on ANZCTR
Registration number
ACTRN12610000940077
Ethics application status
Approved
Date submitted
12/10/2010
Date registered
4/11/2010
Date last updated
25/08/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
CAMERA - Combination Antibiotic treatment for Methicillin Resistant Staphylococcus Aureus
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Scientific title
In adults with methicillin resistant staphylococcus aureus (MRSA) bacteraemia, does the combination of vancomycin plus flucloxacillin lead to a faster resolution of bacteraemia than does vancomycin alone?
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Secondary ID [1]
252858
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N/A
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Universal Trial Number (UTN)
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Trial acronym
CAMERA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Methicillin Resistant Staphylococcus Aureus Bacteraemia
258571
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Condition category
Condition code
Infection
258713
258713
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0
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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
Vancomycin 1.5 grams every 12 hours infused intravenously over 90 minutes (for standard duration of 2-6 weeks) PLUS flucloxacillin 2grams every six hours infused intravenously over 10-30 minutes (for 7 days). Both Vancomycin and Flucloxacillin will be comenced on day one. The duration of Vancomycin treatment will be decided by the treating clinician based on clinical variables and response.
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Intervention code [1]
257543
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Treatment: Drugs
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Comparator / control treatment
Vancomycin 1.5 grams every 12 hours infused intravenously over 90 minutes (for standard duration of 2-6 weeks). The duration of Vancomycin treatment will be decided by the treating clinician based on clinical variables and response.
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Control group
Active
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Outcomes
Primary outcome [1]
259393
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Duration of MRSA bacteraemia. Blood culutres will be collected daily for the first 7 days and, if still postitive at day 7, every 48 hours therafter until negative. A negative blood culture means no growth detected in an automated blood culture system after 48 hours of incubation.
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Timepoint [1]
259393
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Blood cultures will be collected daily for the first 7 days and, if still postitive at day 7, every 48 hours therafter until negative. A negative blood culture means no growth detected in an automated blood culture system after 48 hours of incubation.
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Secondary outcome [1]
265927
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Clinical cure, as judged by an infectious diseases physician. Clinical cure is defined as resolution of fever for more than 48 hours, resolution of all clinical signs of infection, no longer receving any antibiotic treatment for the index infection, and at least one negative blood culutre after the cessation of all antibiotics.
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Timepoint [1]
265927
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90 days post randomisation
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Secondary outcome [2]
265928
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All-cause mortality as determined from hospital discharge data. If the patient is discharged from hospital prior to 28 days post randomisation, they or their general practitioner will be contacted to determine their vital status.
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Timepoint [2]
265928
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28 days post randomisation
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Secondary outcome [3]
265929
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Composite endpoint of development of new renal impairment or WHO grade 2 or higher abnormal liver enzymes. New renal impairment is defined as serum creatinine>1.5 times the upper limit of normal if it was <=1.25 upper limit of normal at trial entry; WHO Grade 2 or higher liver toxicity is defined as one or both of alanine transaminase or gamma glutaryl tranferase of >2.6 times the upper limit of normal
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Timepoint [3]
265929
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First 10 days following randomisation
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Eligibility
Key inclusion criteria
1. MRSA identified in a blood culture drawn within 48 hours prior to randomisation
2. Hospital inpatient with expected stay of at least 7 days
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Minimum age
18
Years
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Maximum age
100
Years
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Gender
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Definite history of allergy to vancomycin or flucloxacillin
2. Renal impairment with estimated Glomerular Filtration Rate (eGFR) <30ml/min
3. Polymicrobial bacteraemia in the index MRSA blood culture
4. Current treatment with a beta-lactam antibiotic which the patient's clinician deems necessary to continue
5. Pregnancy
6. Previous randomisation into this study
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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)
Following written informed consent, the patient will be randomised by sequentially numbered opaque sealed envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified by centre. Randomisation in permuted blocks of variable block size.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Pilot study to determine feasibility and inform design of a larger study with mortality as the primary endpoint. Main aim is to determine the duration of bacteraemia in the treatment and control groups, rather than to demonstrate efficacy.
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Phase
Phase 2
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Type of endpoint(s)
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
22/11/2010
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Actual
12/01/2011
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Date of last participant enrolment
Anticipated
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Actual
6/05/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,NT,WA
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Recruitment postcode(s) [1]
3302
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0811
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Funding & Sponsors
Funding source category [1]
257826
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Government body
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Name [1]
257826
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Northern Territory Research and Innovation Board
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Address [1]
257826
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Ground Floor
Development House
76 The Esplanade
Darwin NT 0800
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Country [1]
257826
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Australia
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Primary sponsor type
Individual
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Name
Dr Joshua Davis
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Address
Menzies School of Health Research
Rocklands Drive
Tiwi
NT 0811
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Country
Australia
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Secondary sponsor category [1]
257027
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Individual
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Name [1]
257027
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Dr Steven Tong
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Address [1]
257027
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Menzies School of Health Research
Rocklands Drive
Tiwi
NT 0811
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Country [1]
257027
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Australia
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Other collaborator category [1]
251556
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Other Collaborative groups
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Name [1]
251556
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Australian Society for Infectious Diseases Clinical Research Network
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Address [1]
251556
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C/- The Royal Australasian College of Physicians
145 Macquarie Street
Sydney, NSW 2000
AUSTRALIA
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Country [1]
251556
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
259856
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Human Research Ethics Committee of the Menzies School of Health Research and Northern Territory Department of Health and Families
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Ethics committee address [1]
259856
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Menzies School of Health Research
Rocklands Drive
Tiwi
NT 0811
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Ethics committee country [1]
259856
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Australia
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Date submitted for ethics approval [1]
259856
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15/07/2010
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Approval date [1]
259856
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12/10/2010
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Ethics approval number [1]
259856
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1/10/1436
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Summary
Brief summary
MRSA bacteraemia has a mortality of 30-40%, exceeding that of sensitive Staphylococcus aureus primarily due to the shortcomings of vancomycin, the standard therapy for MRSA bacteraemia. Whilst several new antibiotics have become available for MRSA, none have been shown to be superior to vancomycin. Although MRSA is by definition resistant to oxacillin, multiple in-vitro and animal studies have demonstrated synergy of vancomycin with beta-lactams (including oxacillin) against MRSA and hetro-resistant vancomycin intermediate Staphylococcus aureus (hVISA). This study aims to answer the following question: In hospitalised adults with MRSA bacteraemia, does combination therapy with vancomycin and flucloxacillin lead to a shorter time to clearance of bacteraemia than vancomycin alone?
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
31761
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Dr Josh Davis
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Address
31761
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Menzies School of Health Research Rocklands Drive Tiwi NT 0811
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Country
31761
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Australia
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Phone
31761
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+61 8 89448005
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Fax
31761
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Email
31761
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Joshua.Davis@menzies.edu.au
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Contact person for public queries
Name
15008
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Dr Dr Josh Davis
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Address
15008
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Menzies School of Health Research
Rocklands Drive
Tiwi NT 0811
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Country
15008
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Australia
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Phone
15008
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+61 8 89448005
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Fax
15008
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Email
15008
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Joshua.Davis@menzies.edu.au
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Contact person for scientific queries
Name
5936
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Dr Dr Josh Davis
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Address
5936
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Menzies School of Health Research
Rocklands Drive
Tiwi NT 0811
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Country
5936
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Australia
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Phone
5936
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+61 8 89448005
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Fax
5936
0
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Email
5936
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Joshua.Davis@menzies.edu.au
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No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
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Other publications
Have study results been made publicly available in another format?
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Results – basic reporting
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Results – plain English summary
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