Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial
The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139.
We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomised, Open, Parallel Group Clinical Trial to Compare the Efficacy and Safety of a Single Dose of Ciprofloxacin Oral Suspension 20 Mg/Kg With a 3-Day Course of Erythromycin Oral Suspension Administered in a Dose of 12.5 Mg/Kg Every 6 Hours (12 Doses) in the Treatment of Children,With Clinically Severe Cholera Due to V. Cholerae O1 or O139.|
- Rates of clinical success
- Rates of bacteriologic success at test of cure visit.
- Duration of diarrhoea.
- Rates of clinical relapse.
- Rates of bacteriologic relapse.
- Duration of faecal excretion of V. cholerae O1 or V. cholerae O139.
- Measurements of six-hourly volume of watery stool will be done for the period in which patients are hospitalised.
- Proportion of patients requiring unscheduled intravenous fluids.
- Frequency of vomiting and its volume.
- Frequency of stool per day.
- Frequency of vomit per day.
- PK-assessment of serum and stool.
|Study Start Date:||May 2001|
|Estimated Study Completion Date:||July 2002|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142272
|International Centre for Diarrhoeal Disease Research, Bangladesh|
|Dhaka, Bangladesh, 1212|
|Study Director:||Debasish Saha, MBBS,MS||International Centre for Diarrhoeal Disease Research, Bangladesh|