NNITS-Nitazoxanide for Norovirus in Transplant Patients Study
Condition: Gastroenteritis Norovirus
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 2

Summary: 
      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 involves a total
      of 160 Hematopoietic Stem Cell or Solid Organ transplant recipients, equal to or greater than
      12 years of age with diagnosis of Norovirus who will be selected and randomly assigned (1:1)
      to nitazoxanide or placebo group. The study duration is 60 months and subject participation
      duration is 6 months. Given the safety of prolonged therapy with nitazoxanide, lack of
      interactions with common post-transplant medications, putative antiviral activity and
      prolonged duration of viral shedding we are assessing 56 doses of therapy. The longitudinal
      monitoring phase will provide useful information on the course of host and viral responses in
      subjects with chronic Norovirus infection with and without treatment. 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. Longitudinal Monitoring Phase which will include telephone call on Days 35, 53, 113,
      173. Primary objective is 1) to assess the clinical efficacy of nitazoxanide for the
      management of acute and chronic Norovirus in transplant recipients.
    

Detailed 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 involves a total
      of 160 Hematopoietic Stem Cell or Solid Organ transplant recipients, equal to or greater than
      12 years of age with diagnosis of Norovirus who will be selected and randomly assigned (1:1)
      into two treatment groups: nitazoxanide or placebo. The study duration is approximately 60
      months and subject participation duration is approximately 6 months. Given the safety of
      prolonged therapy with nitazoxanide, lack of interactions with common post-transplant
      medications, putative antiviral activity and prolonged duration of viral shedding we are
      assessing 56 doses of therapy. The longitudinal monitoring phase will provide useful
      information on the course of host and viral responses in subjects with chronic Norovirus
      infection with and without treatment. 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. Longitudinal
      Monitoring Phase which will include telephone call on Days 35, 53, 113, 173. 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.
    

Intervention name(s): Nitazoxanide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): One 500 mg tablet twice daily with food for 56 consecutive doses; One tablet twice daily with food for 56 consecutive doses
Intervention MeSH terms: Nitazoxanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Efficacy; Hematopoietic Stem Cell; Nitazoxanide; Norovirus; Prospective, Randomized, Double-Blind Study; Safety; Solid Organ Transplant Recipients; Treatment