NNITS-Nitazoxanide for Norovirus in Transplant Patients Study
Status:
Active, not recruiting
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)