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ISRCTN
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ISRCTN68138140
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ClinicalTrials.gov identifier
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Public title
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Molecular Diagnosis of Central Venous Catheter (CVC) associated infections
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Scientific title
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Acronym
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MD-CVC
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Serial number at source
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HTA 03/39/13; N0484156267
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Study hypothesis
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Central Venous Catheters (CVCs) are an essential part of the management of children undergoing treatment for cancer because they allow the safe administration of life-saving cancer drugs. Blood stream infection is a frequent and potentially serious complication of the use of CVCs. Some CVC associated infections can be treated by leaving the CVC where it is but frequently the best management involves taking the CVC out. Current methods of diagnosing CVC associated infection are unreliable with a result that more than 80% of CVCs removed for suspected infection are not in fact the source of infection. Also because of the difficulty in making a diagnosis, CVC associated infections may not be diagnosed or treated as early or as well as they can be.
In this study we will determine how best to use this test in children undergoing treatment for cancer and then find out if this new and relatively expensive test should be made available more widely.
In summary, we aim to find out whether the new test helps with the management of children with a central venous catheter, and improves the health outcomes.
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Ethics approval
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No ethics information provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Central Venous Catheter Associated Infections
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Participants - inclusion criteria
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1. Child, adolescent or young adult aged zero 18 years inclusive
2. Undergoing treatment for cancer/leukaemia or severe haematological disorders at a collaborating United Kingdom Children's Cancer Study Group (UKCCSG) centre
3. The routine standard of care requires a tunnelled single, double or triple lumen CVC or implanted vascular port
4. It is expected that the CVC or port will be required for a minimum of three months
5. Patients who already have an indwelling vascular access device in situ at the time of recruitment are eligible if they have been apyrexial and have not received intravenous antimicrobial therapy in the preceding two weeks
6. Written informed consent has been obtained from the parent/guardian and assent from the patient where appropriate
7. National/Local Ethical Committee approval has been obtained
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Participants - exclusion criteria
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1. Failure to meet the above criteria
2. Patients with untunnelled CVCs or short term CVCs will not be included
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Anticipated start date
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01/06/2005
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Anticipated end date
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30/11/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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330
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Interventions
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There are two parts to the study:
In part one, we will determine how a novel molecular test for the diagnosis of CVC-associated infections performs in children being treated for cancer.
In the second part, we will determine the impact of the test as an adjunct to standard care on CVC management. Patients will be randomised to availability of the test plus standard care or standard care only.
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Primary outcome measure(s)
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CVC survival
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Secondary outcome measure(s)
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1. Duration of antibiotic treatment and hospitalisation for fever
2. Mortality
3. Economic analysis
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Contact name
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Dr
Michael
Millar
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Address
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Department of Microbiology
37 Ashfield Street
Whitechapel
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City/town
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London
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Zip/Postcode
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E1 1BB
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Country
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United Kingdom
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Tel
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+44 (0)20 73773078
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Fax
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+44 (0)20 73777330
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Email
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M.R.millar@qmul.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/11/2004
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Last edited
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16/01/2008
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Date ISRCTN assigned
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14/12/2004
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