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ISRCTN
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ISRCTN67946944
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ClinicalTrials.gov identifier
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Public title
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An open randomised study to assess the efficacy of gatifloxacin versus azithromycin for the treatment of uncomplicated typhoid fever
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Scientific title
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Acronym
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BJ Study
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Serial number at source
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061330
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Study hypothesis
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There has been a dramatic change in Viet Nam in the sensitivity of Salmonella typhi (the bacteria that causes typhoid fever) to all antibiotics. In the Mekong Delta more than 95% of isolates are resistant to all first line antibiotics (defined as multidrug resistant) and show significantly poorer clinical response to the older fluoroquinolones. There is the very real risk that typhoid fever in Viet Nam will soon become effectively untreatable. There is an urgent need to develop treatments that combine speed of clinical response, reduction in secondary transmission and protection from the development of resistance. From uncontrolled clinical data from a small number of patients treated at Dong Thap Hospital in Viet Nam and from in vitro sensitivity data gatifloxacin maybe a suitable new treatment for multidrug resistant Typhoid 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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Viet Nam
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Disease/condition/study domain
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Typhoid fever
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Participants - inclusion criteria
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Patients will be eligible if they have suspected or culture proven enteric fever provided:
1. They give fully informed consent
2. They are not obtunded not jaundiced
3. There are no signs of gastrointestinal (GI) bleeding or any other evidence of severity (see below)
4. No history of hypersensitivity to either of the trial drugs
5. No treatment with a quinolone or 3rd generation cephalosporin or macrolide within one week of hospital admission
6. They are not pregnant
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Participants - exclusion criteria
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1. Pregnancy or lactation
2. Any signs of symptoms of severe disease
3. No informed consent
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Anticipated start date
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01/10/2005
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Anticipated end date
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30/09/2006
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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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To be added
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Interventions
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An open randomised two-way comparison of gatifloxacin (10 mg/kg/day) versus azithromycin (20 mg/kg/day) for seven days for the treatment of symptomatic uncomplicated typhoid fever.
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Primary outcome measure(s)
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Fever Clearance Time.
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Secondary outcome measure(s)
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Clinical and Microbiological 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 in http://www.ncbi.nlm.nih.gov/pubmed/18493312
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Contact name
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Dr
Jeremy
Farrar
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Address
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Hospital for Tropical Diseases
The Hospital for Tropical Diseases
Oxford University Clinical Research
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 88362225
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Fax
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+84 89238904
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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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22/05/2008
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Date ISRCTN assigned
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22/07/2005
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