Rotavirus Infection, Viral Gastroenteritis Due to Rotavirus
Conditions
Keywords
Rotavirus, Viral gastroenteritis, Gastroenteritis
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.
Interventions
DRUGNitazoxanide
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
Sponsors
Romark Laboratories L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from first dose to resolution of symptoms. | Up to 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from first dose to virologic response | Up to 14 days | 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 from first dose to hospital discharge | Up to 14 days | For hospitalized patients, the study will monitor the time in hours from the first dose of study medication to discharge from the hospital. |
| 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 | — |
Countries
Egypt
Outcome results
None listed