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ISRCTN
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ISRCTN06126383
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ClinicalTrials.gov identifier
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Public title
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Antibiotics with catheter withdrawal (a randomised double blind placebo controlled trial)
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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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N0277104938
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Study hypothesis
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Null hypothesis: antibiotic use on catheter removal does significantly reduce the risk of developing a clinically significant urinary tract infection (UTI)
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Lay summary
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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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Randomised double blind placebo 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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Urinary tract infection (UTI)
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Participants - inclusion criteria
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150 in-patients with in-dwelling catheters about to be removed will be blinded into two arms of the study (test and placebo)
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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10/10/2001
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Anticipated end date
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01/10/2004
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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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150
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Interventions
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Removing the catheter and collection of two urine samples (immediately and 7 days later). Antibiotic or placebo prescribed for 48 hours after catheter removal.
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Primary outcome measure(s)
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If antibiotics are advocated, this will become a guideline for all health professionals using catheters. If antibiotics are unnecessary, this will help to decrease the incidence of antimicrobial resistance and reduce the financial burden of antibiotic use in this group.
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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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Whittington Hospital NHS Trust (UK)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/15541126
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Contact name
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Dr
H
Wazait
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Address
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Department of Urology
2nd floor, Jenner Building
Whittington Hospital
Highgate Hill
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City/town
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London
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Zip/Postcode
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N19 5NF
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Country
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United Kingdom
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Tel
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+44 (0)20 7288 5221
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Email
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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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09/07/2009
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Date ISRCTN assigned
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30/09/2004
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