Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children

Romark Laboratories L.C.50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rotavirus Infection Adenoviridae Infection Norovirus Infection

Interventions

Alinia (nitazoxanide)DRUG

Eligibility

Sex: ALLMax age: 11 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \<12 years. * Patients with diarrhea (defined as 3 or more stools per day with liquid or semi-solid consistency, the number and consistency of stools being unusual for that person). * Stool positive for adenovirus, norovirus or rotavirus by ELISA. Exclusion Criteria: * Females who are pregnant, suspected of being pregnant or breastfeeding. * Other identified causes of diarrhea at screening. * Serious systemic disorders incompatible with the study.

Outcomes

Primary Outcomes

Time from first dose to resolution of symptoms.

Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group

Time frame: P-0.0105

Secondary Outcomes

Virologic response (negative ELISA) at day 7-10.

Data from ClinicalTrials.gov

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