Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial
|ClinicalTrials.gov Identifier: NCT00142272|
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : November 21, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Cholera||Drug: Ciprofloxacin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||May 2001|
|Estimated Study Completion Date :||July 2002|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142272
|International Centre for Diarrhoeal Disease Research, Bangladesh|
|Dhaka, Bangladesh, 1212|
|Study Director:||Debasish Saha, MBBS,MS||International Centre for Diarrhoeal Disease Research, Bangladesh|