An open randomised study to assess the efficacy of gatifloxacin versus azithromycin for the treatment of uncomplicated typhoid fever

ISRCTN ISRCTN67946944
DOI https://doi.org/10.1186/ISRCTN67946944
Secondary identifying numbers 061330
Submission date
22/07/2005
Registration date
22/07/2005
Last edited
11/03/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jeremy Farrar
Scientific

Hospital for Tropical Diseases
The Hospital for Tropical Diseases
Oxford University Clinical Research
190 Ben Ham Tu
Ho Chi Minh City
5
Viet Nam

Phone +84 88362225
Email jfarrar@oucru.org

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymBJ Study
Study objectivesThere 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedTyphoid fever
InterventionAn 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Gatifloxacin and azithromycin
Primary outcome measureFever Clearance Time.
Secondary outcome measuresClinical and Microbiological Failure.
Overall study start date01/10/2005
Completion date30/09/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsTo be added
Key inclusion criteriaPatients 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
Key exclusion criteria1. Pregnancy or lactation
2. Any signs of symptoms of severe disease
3. No informed consent
Date of first enrolment01/10/2005
Date of final enrolment30/09/2006

Locations

Countries of recruitment

  • Viet Nam

Study participating centre

Hospital for Tropical Diseases
Ho Chi Minh City
5
Viet Nam

Sponsor information

University of Oxford (UK)
University/education

University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom

Website http://www.ox.ac.uk
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 061330)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 21/05/2008 Yes No