An open randomised comparison of Gatifloxacin versus Cefixime for the treatment of uncomplicated enteric fever
| ISRCTN | ISRCTN75784880 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75784880 |
| Secondary identifying numbers | 061330 |
- Submission date
- 22/07/2005
- Registration date
- 22/07/2005
- Last edited
- 11/03/2013
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jeremy Farrar
Scientific
Scientific
Oxford University Clinical Research Unit
The Hospital for Tropical Diseases
190 Ben Ham Tu
Ho Chi Minh City
5
Viet Nam
| Phone | +84 8 8362225 |
|---|---|
| jfarrar@oucru.org |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | DM Study |
| Study objectives | To determine the relative efficacy of gatifloxacin and cefixime in treating culture confirmed enteric fever |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gatifloxacin and cefixime |
| Primary outcome measure | 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 study start date | 02/06/2005 |
| Completion date | 31/12/2006 |
| Reason abandoned (if study stopped) | Safety reasons |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 169 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/06/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Nepal
- Viet Nam
Study participating centre
Oxford University Clinical Research Unit
Ho Chi Minh City
5
Viet Nam
5
Viet Nam
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Website | http://www.ox.ac.uk |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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: | 27/06/2007 | Yes | No |
