Contact information
Type
Scientific
Primary contact
Dr Jeremy Farrar
ORCID ID
Contact details
Hospital for Tropical Diseases
The Hospital for Tropical Diseases
Oxford University Clinical Research
190 Ben Ham Tu
Ho Chi Minh City
5
Viet Nam
+84 88362225
jfarrar@oucru.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
061330
Study information
Scientific title
Acronym
BJ Study
Study hypothesis
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.
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
Typhoid fever
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Gatifloxacin and azithromycin
Primary outcome measures
Fever Clearance Time.
Secondary outcome measures
Clinical and Microbiological Failure.
Overall trial start date
01/10/2005
Overall trial end date
30/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
To be added
Participant exclusion criteria
1. Pregnancy or lactation
2. Any signs of symptoms of severe disease
3. No informed consent
Recruitment start date
01/10/2005
Recruitment end date
30/09/2006
Locations
Countries of recruitment
Viet Nam
Trial participating centre
Hospital for Tropical Diseases
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/18493312
Publication citations
-
Results
Dolecek C, Tran TP, Nguyen NR, Le TP, Ha V, Phung QT, Doan CD, Nguyen TB, Duong TL, Luong BH, Nguyen TB, Nguyen TA, Pham ND, Mai NL, Phan VB, Vo AH, Nguyen VM, Tran TT, Tran TC, Schultsz C, Dunstan SJ, Stepniewska K, Campbell JI, To SD, Basnyat B, Nguyen VV, Nguyen VS, Nguyen TC, Tran TH, Farrar J, A multi-center randomised controlled trial of gatifloxacin versus azithromycin for the treatment of uncomplicated typhoid fever in children and adults in Vietnam., PLoS ONE, 2008, 3, 5, e2188, doi: 10.1371/journal.pone.0002188.