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 |
| Protocol serial number | 061330 |
| Sponsor | University of Oxford (UK) |
| Funder | The Wellcome Trust (UK) (grant ref: 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
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 |
|---|---|
| jfarrar@oucru.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | BJ Study |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Gatifloxacin and azithromycin |
| Primary outcome measure(s) |
Fever Clearance Time. |
| Key secondary outcome measure(s) |
Clinical and Microbiological Failure. |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key 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 |
| Key exclusion criteria | 1. Pregnancy or lactation 2. Any signs of symptoms of severe disease 3. No informed consent |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
Hospital for Tropical Diseases
Ho Chi Minh City
5
Viet Nam
5
Viet Nam
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
