Last updated on December 2018

Efficacy and Safety of Nitazoxanide for the Treatment of Norovirus


Brief description of study

This is a phase 2 multi-center, double-blind, placebo-controlled study of the efficacy and safety of nitazoxanide for the treatment of solid organ and hematopoietic stem cell transplant recipients with symptomatic diarrhea due to Norovirus. The study duration is 60 months and subject participation duration is 6 months. A total of 160 subjects greater than or equal to 12 years of age will be selected. Upon enrollment in the study, subjects will be randomized into two treatment groups: active nitazoxanide and placebo. Randomization will be stratified by age group (pediatric (12 through 17 years) vs. adult (greater than or equal to 18 years)), chronicity of Norovirus-associated symptoms (acute (less than 14 days) vs. chronic (greater than or equal to 14 days)) and transplant type (solid organ (SOT)) vs. hematopoietic stem cell transplant (HSCT)). Enrolled subjects will participate in 2 phases of the study: Treatment Phase, which will include dosing with the assigned study agent for 28 days and study visits on study Day 1, 7, 14, 21, and 28; Longitudinal Monitoring Phase which will include telephone call on Day 35 study visits on study Day 60, 120 and 180 days. Primary objective is 1) to assess the clinical efficacy of nitazoxanide for the management of acute and chronic Norovirus in transplant recipients.

Detailed Study Description

This is a phase 2 multi-center, double-blind, placebo-controlled study of the efficacy and safety of nitazoxanide for the treatment of solid organ and hematopoietic stem cell transplant recipients with symptomatic diarrhea due to Norovirus. The study duration is 60 months and subject participation duration is 6 months. A total of 160 subjects greater than or equal to 12 years of age will be selected. Upon enrollment in the study, subjects will be randomized into two treatment groups: active nitazoxanide and placebo. Randomization will be stratified by age group (pediatric (12 through 17 years) vs. adult (greater than or equal to 18 years)), chronicity of Norovirus-associated symptoms (acute (less than 14 days) vs. chronic (greater than or equal to 14 days)) and transplant type (solid organ (SOT)) vs. hematopoietic stem cell transplant (HSCT)). Enrolled subjects will participate in 2 phases of the study: Treatment Phase, which will include dosing with the assigned study agent for 28 days and study visits on study Day 1, 7, 14, 21, and 28; Longitudinal Monitoring Phase which will include telephone call on Day 35 study visits on study Day 60, 120 and 180 days. Primary objective is 1) to assess the clinical efficacy of nitazoxanide for the management of acute and chronic Norovirus in transplant recipients. Secondary Objectives are 1) to assess the virologic efficacy of nitazoxanide and 2) to assess the safety of nitazoxanide for the management of acute and chronic Norovirus in transplant recipients.

Clinical Study Identifier: NCT03395405

Contact Investigators or Research Sites near you

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Michael Grundel Ison

Fred Hutchinson Cancer Research Center - Vaccine and Infectious Diseases
Seattle, WA United States
1.69miles
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Michael Grundel Ison

University of Washington - Medicine
Seattle, WA United States
3.28miles
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Recruitment Status: Open


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