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ISRCTN
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ISRCTN75784880
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ClinicalTrials.gov identifier
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Public title
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An open randomised comparison of Gatifloxacin versus Cefixime for the treatment of uncomplicated enteric fever
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Scientific title
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Acronym
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DM Study
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Serial number at source
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061330
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Study hypothesis
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To determine the relative efficacy of gatifloxacin and cefixime in treating culture confirmed enteric fever
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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 controlled trial
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Countries of recruitment
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Nepal
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Disease/condition/study domain
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Enteric fever
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Participants - inclusion criteria
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1. The treating physician believes the diagnosis to be enteric fever
2. More than or equal to three days history of fever, headache and oral temperature more than or equal to 37.8 °C
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Participants - exclusion criteria
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1. Complicated typhoid (jaundice, shock, peritonism, gastrointestinal bleeding, myocarditis, encephalopathy)
2. Pregnancy
3. Lactation
4. Allergy to study drug
5. Quinolone, fluoroquinolone, macrolide or 3rd generation cephalosporin treatment within previous week
6. Unable to take oral medication
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Anticipated start date
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02/06/2005
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Anticipated end date
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31/12/2006
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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169
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Interventions
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Open label randomised controlled trial of gatifloxacin versus cefixime.
Please note that due to safety reasons this trial was terminated on the 8th September 2005.
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Primary outcome measure(s)
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Time to fever clearance
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Secondary outcome measure(s)
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1. Development of complications
2. Blood culture sterilisation
3. Eradication of stool carriage
4. Need for retreatment
5. Development of enteric fever in household contacts
6. Treatment failure
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 061330)
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Trial website
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Publications
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Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17593957
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Contact name
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Dr
Jeremy
Farrar
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Address
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Oxford University Clinical Research Unit
The Hospital for Tropical Diseases
190 Ben Ham Tu
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City/town
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Ho Chi Minh City
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Zip/Postcode
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5
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Country
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Viet Nam
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Tel
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+84 8 8362225
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Fax
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+84 8 9238904
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Email
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jeremyjf@hcm.vnn.vn
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Sponsor
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University of Oxford (UK)
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Address
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University Offices
Wellington Square
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City/town
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Oxford
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Zip/Postcode
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OX1 2JD
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Country
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United Kingdom
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Tel
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+44 (0)1865 270143
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Fax
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+44 (0)1865 280467
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Email
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research.services@admin.ox.ac.uk
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Sponsor website:
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http://www.ox.ac.uk
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Date applied
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22/07/2005
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Last edited
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13/12/2007
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Date ISRCTN assigned
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22/07/2005
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