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The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitazoxanide | Active Comparator | 7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days |
|
| Placebo | Placebo Comparator | 7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alinia (nitazoxanide) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from first dose to resolution of symptoms. | Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group | P-0.0105 |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic response (negative ELISA) at day 7-10. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona Abu-Zekry, MD | Cairo University Children's Hospital, Cairo, Egypt | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16829296 | Result | Rossignol JF, Abu-Zekry M, Hussein A, Santoro MG. Effect of nitazoxanide for treatment of severe rotavirus diarrhoea: randomised double-blind placebo-controlled trial. Lancet. 2006 Jul 8;368(9530):124-9. doi: 10.1016/S0140-6736(06)68852-1. |
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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D000257 | Adenoviridae Infections |
| D017250 | Caliciviridae Infections |
| 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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| D004266 |
| DNA Virus Infections |