The purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Nitazoxanide Oral Suspension dose based on age: Age \<12 months- 7.5 mg/kg by mouth twice daily for 3 days; Age 12-47 months- 100 mg/5 ml by mouth twice daily for 3 days; Age 48-72 months- 200 mg/10 ml by mouth twice daily for 3 days
Cairo University Children's Hospital
Cairo, Egypt
Time from first dose to resolution of symptoms.
Resolution of all gastrointestinal symptoms associated with viral diarrhea at enrollment including abdominal pain or tenderness, distention, etc. with the patient not requiring anti-motility or other palliative treatment. Symptom resolution must be maintained for at least 48 hours to be considered valid.
Time frame: Up to 14 days
Time from first dose to virologic response
Daily stool samples will be analyzed by ELISA for the presence of rotavirus. Virologic response is defined by a negative ELISA stool test for rotavirus on 2 consecutive days.
Time frame: Up to 14 days
Time from first dose to hospital discharge
For hospitalized patients, the study will monitor the time in hours from the first dose of study medication to discharge from the hospital.
Time frame: Up to 14 days
Volume of oral rehydration solutions consumed
Time frame: Up to 14 days
Frequency of intravenous rehydration required
Time frame: Up to 14 days
Stool weight
Time frame: Up to 14 days
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