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An open randomised comparison of Gatifloxacin versus Cefixime for the treatment of uncomplicated enteric fever
ISRCTN ISRCTN75784880
DOI 10.1186/ISRCTN75784880
ClinicalTrials.gov identifier
EudraCT number
Public title An open randomised comparison of Gatifloxacin versus Cefixime for the treatment of uncomplicated enteric fever
Scientific title
Acronym DM Study
Serial number at source 061330
Study hypothesis To determine the relative efficacy of gatifloxacin and cefixime in treating culture confirmed enteric fever
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Nepal
Disease/condition/study domain Enteric fever
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 02/06/2005
Anticipated end date 31/12/2006
Status of trial Stopped
Patient information material
Target number of participants 169
Interventions 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.
Primary outcome measure(s) Time to fever clearance
Secondary outcome measure(s) 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
Sources of funding The Wellcome Trust (UK) (grant ref: 061330)
Trial website
Publications Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17593957
Contact name Dr  Jeremy  Farrar
  Address Oxford University Clinical Research Unit
The Hospital for Tropical Diseases
190 Ben Ham Tu
  City/town Ho Chi Minh City
  Zip/Postcode 5
  Country Viet Nam
  Tel +84 8 8362225
  Fax +84 8 9238904
  Email jfarrar@oucru.org
Sponsor University of Oxford (UK)
  Address University Offices
Wellington Square
  City/town Oxford
  Zip/Postcode OX1 2JD
  Country United Kingdom
  Tel +44 (0)1865 270143
  Fax +44 (0)1865 280467
  Email research.services@admin.ox.ac.uk
  Sponsor website: http://www.ox.ac.uk
Date applied 22/07/2005
Last edited 11/03/2013
Date ISRCTN assigned 22/07/2005
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