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ISRCTN
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ISRCTN63718248
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ClinicalTrials.gov identifier
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Public title
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A phase III, randomised, double blind, multicentre study to evaluate the safety and efficacy of dalbavancin versus linezolid in the treatment of complicated skin and soft tissue infections with suspected gram-positive bacterial pathogens
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0123138529
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Study hypothesis
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To compare how safe the trial medication dalbavancin is when compared to a standard of care treatment in patients suffering from complicated skin infections
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Ethics approval
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Not provided at time of registration
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Study design
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Phase III randomised double blind multicentre study
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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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Infections and Infestations: Gram-positive bacterial pathogens
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Participants - inclusion criteria
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1. Patients having infection consistent with complicated skin and soft tissue infection either involving deeper soft tissue or requiring significant surgical intervention
2. Patients to require 24hrs of parental therapy for suspected gram-positive complicated skin
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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30/09/2003
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Anticipated end date
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05/08/2004
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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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Not provided at time of registration
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Interventions
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Dalbavancin vs standard care
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Primary outcome measure(s)
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The clinical and microbiological responses to therapy.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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University Hospitals of Leicester NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Martin
Wiselka
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Address
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University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
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City/town
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Leicester
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Zip/Postcode
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LE1 4PW
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Country
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United Kingdom
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Tel
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+44 (0)116 258 4109
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Fax
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+44 (0)116 258 4226
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Email
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martin.wiselka@uhl-tr.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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29/06/2010
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Date ISRCTN assigned
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30/09/2004
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