A research study to compare 2 antibacterial drugs, gatifloxacin with ciprofloxacin, for the treatment of dysentery in children
| ISRCTN | ISRCTN55945881 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55945881 |
| Secondary identifying numbers | 061330 |
- Submission date
- 15/01/2008
- Registration date
- 18/01/2008
- Last edited
- 13/03/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Vinh Ha
Scientific
Scientific
Oxford University Clinical Research Unit
Hospital for Tropical Diseases
Ho Chi Minh City
5
Viet Nam
| Phone | +84 8 9237954 |
|---|---|
| vinhh@oucru.org |
Study information
| Study design | Open-label randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial of gatifloxacin versus ciprofloxacin for the treatment of bacillary dysentery in children |
| Study acronym | EG |
| Study objectives | In 2004, The World Health Organization (WHO) organised a meeting of experts around the world and recommended that ciprofloxacin or other fluoroquinolones should be used to treat shigellosis in children as well as adults. However after being used for some years to treat shigellosis, the clinical response to ciprofloxacin treatment has decreased, strains of Shigella dysenteriae type 1 resistant to ciprofloxacin were also detected. This is why searching for alternative regimens is obviously needed. This study will compare the currently recommended WHO regimen with a newer, affordable and potentially more active fluoroquinolone, i.e., gatifloxacin. |
| Ethics approval(s) | Ethics approval received from Oxford Tropical Research Ethics Committee on the 20th June 2006 (ref: OXTREC 010-06). |
| Health condition(s) or problem(s) studied | Shigella dysentery |
| Intervention | Patients are randomised to: 1. Ciprofloxacin 15 mg/kg body weight taken orally every 12 hours for a total of 6 doses in 3 days, or 2. Gatifloxacin 10 mg/kg body weight taken orally every 24 hours for a total of 3 doses in 3 days Follow-up will occur for 7 - 10 days after discharge from the hospital. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ciprofloxacin, gatifloxacin |
| Primary outcome measure | Failure of treatment: 1. Persistent fever at Day 5 2. Failure to clear completely the admission symptoms at Day 5 3. Stool culture positive at Day 3 of treatment 4. Need for rescue treatment with ceftriaxone 5. The development on treatment of any complication |
| Secondary outcome measures | 1. Fever clearance time: from the start of treatment until axillary temperature falls to 37.5°C and remains at or below this value for greater than 48 hours 2. Bloody diarrhoea clearance time: the time to the last stool containing visible blood passed 3. Diarrhoea clearance time: the time to the first formed stool 4. Bacterial clearance time: time to the last positive stools culture for Shigella |
| Overall study start date | 01/06/2006 |
| Completion date | 30/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 366 |
| Key inclusion criteria | 1. Patients aged 0 - 14, either sex 2. Symptomatic uncomplicated dysentery 3. Gives consent |
| Key exclusion criteria | No consent given. |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 30/03/2009 |
Locations
Countries of recruitment
- 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
| Phone | +44 (0)1865 270143 |
|---|---|
| research.services@admin.ox.ac.uk | |
| 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 | 15/12/2009 | Yes | No | |
| Results article | results | 01/08/2011 | Yes | No |
