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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitazoxanide Oral Suspension | Experimental | Nitazoxanide Oral Suspension 100 mg/5 ml |
|
| Placebo Oral Suspension | Placebo Comparator | Placebo Oral Suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitazoxanide | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona Abu-Zekry, MD | Cairo University Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Children's Hospital | Cairo | Egypt |
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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C041747 | nitazoxanide |
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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 |
| D005767 |
| Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |