Contact information
Type
Scientific
Primary contact
Dr Jeremy Farrar
ORCID ID
Contact details
Oxford University Clinical Research Unit
The Hospital for Tropical Diseases
190 Ben Ham Tu
Ho Chi Minh City
5
Viet Nam
+84 8 8362225
jfarrar@oucru.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
061330
Study information
Scientific title
Acronym
DM Study
Study hypothesis
To determine the relative efficacy of gatifloxacin and cefixime in treating culture confirmed enteric fever
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Enteric fever
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Gatifloxacin and cefixime
Primary outcome measures
Time to fever clearance
Secondary outcome measures
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
Overall trial start date
02/06/2005
Overall trial end date
31/12/2006
Reason abandoned
Safety reasons
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
169
Participant 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
Recruitment start date
02/06/2005
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Nepal
Trial participating centre
Oxford University Clinical Research Unit
Ho Chi Minh City
5
Viet Nam
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 061330)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Publication citations
-
Results
Pandit A, Arjyal A, Day JN, Paudyal B, Dangol S, Zimmerman MD, Yadav B, Stepniewska K, Campbell JI, Dolecek C, Farrar JJ, Basnyat B, An open randomized comparison of gatifloxacin versus cefixime for the treatment of uncomplicated enteric fever., PLoS ONE, 2007, 2, 6, e542, doi: 10.1371/journal.pone.0000542.