Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

Conditions
-----------------
Rotavirus Infection, Viral Gastroenteritis Due to Rotavirus

Intervention / Treatment
-----------------
* Drug: Nitazoxanide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 6 years. Patients with diarrhea (defined as 3 or more liquid stools per day). Stool positive for rotavirus by ELISA. Exclusion Criteria: Other identified causes of diarrhea at screening (pathogenic protozoa, bacteria, viruses or lactose intolerance). Serious systemic disorders incompatible with the study.

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitazoxanide Oral Suspension<br>Nitazoxanide Oral Suspension 100 mg/5 ml | Drug: Nitazoxanide<br>* 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<br>* Other names: NTZ;|
| Placebo Comparator: Placebo Oral Suspension<br>Placebo Oral Suspension | Drug: Nitazoxanide<br>* 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<br>* Other names: NTZ;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 14 days | 
| Volume of oral rehydration solutions consumed |  | Up to 14 days | 
| Frequency of intravenous rehydration required |  | Up to 14 days | 
| Stool weight |  | Up to 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroenteritis, Rotavirus, Viral gastroenteritis