A comparison of azithromycin and ofloxacin in the treatment of typhoid in adult patients in Laos
ISRCTN | ISRCTN66534807 |
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DOI | https://doi.org/10.1186/ISRCTN66534807 |
Secondary identifying numbers | 066828 |
- Submission date
- 07/12/2005
- Registration date
- 07/12/2005
- Last edited
- 02/02/2009
- 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 Paul Newton
Scientific
Scientific
Microbiology laboratory
Ministry of Health
Mahosot Hospital
Mahosot Road
Vientiane
-
Lao People's Democratic Republic
Phone | +856 (0)21 250752 |
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paul@tropmedres.ac |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A randomised clinical trial of Azithromycin versus Ofloxacin in the treatment of adults with uncomplicated typhoid fever at Mahosot Hospital, Vientiane, Lao People's Democratic Republic (PDR) |
Study acronym | AO |
Study objectives | To conduct an open, randomised comparative clinical trial of oral azithromycin, versus ofloxacin in the treatment of 88 adults with uncomplicated typhoid fever at Mahosot Hospital, Vientiane, Lao PDR. The primary outcome measures will be fever clearance, cure rate, relapse rate and S. typhi stool carriage rate. Trial details submitted to the Wellcome Trust 8th June 2005. Please note that as of 21/01/08 this trial was stopped. This is because the incidence of typhoid in Vientiane has declined. We have permission to continue the trial should the incidence rise or if there is an epidemic. |
Ethics approval(s) | 1. Oxford Tropical Ethics Committee (OXTREC) gave approval on the 6th May 2004 (ref: OXTREC 006-04) 2. Faculty of Medical Sciences, Vientiane, Laos Ethical Committee gave approval on the 2nd April 2004 (ref: FMS 2/4/2004) |
Health condition(s) or problem(s) studied | Typhoid fever |
Intervention | A randomised, open clinical trial with random allocation to three days ofloxacin or three days azithromycin. Please note that the anticipated end date has been extended to 31st December 2008. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Azithromycin and ofloxacin |
Primary outcome measure | The primary outcome measures are fever clearance, cure rate, relapse rate and S. typhi stool carriage rate. |
Secondary outcome measures | No secondary outcome measures |
Overall study start date | 01/05/2004 |
Completion date | 31/12/2006 |
Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 88 |
Key inclusion criteria | 1. Adult (more than or equal to 15 years, either sex) non-pregnant patients with suspected or blood culture proven typhoid 2. Fever more than 37.5 °C 3. Informed written consent to the study 4. Able to stay in hospital for seven days 5. Able to take oral medication 6. Body weight more than 40 kg 7. Likely to be able to complete six months follow up 8. None of the exclusion criteria |
Key exclusion criteria | 1. Known hypersensitivity to ofloxacin or azithromycin 2. Administration of chloramphenicol, co-trimoxazole, ampicillin, azithromycin or a fluoroquinolone during the previous week 3. Pregnancy or breast feeding 4. Contraindications to ofloxacin or azithromycin 5. Evidence for severe typhoid |
Date of first enrolment | 01/05/2004 |
Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Lao People's Democratic Republic
Study participating centre
Microbiology laboratory
Vientiane
-
Lao People's Democratic Republic
-
Lao People's Democratic Republic
Sponsor information
University of Oxford (UK)
University/education
University/education
Churchill Hospital
CCVTM
Headington
Oxford
OX3 7LJ
England
United Kingdom
Website | http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine |
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https://ror.org/052gg0110 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 066828)
No information available
Results and Publications
Intention to publish date | |
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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 |