NNITS-Nitazoxanide for Norovirus in Transplant Patients Study
Public ClinicalTrials.gov record NCT03395405. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Multi-Center, Prospective, Randomized, Double-Blind Study to Assess the Clinical and Antiviral Efficacy and Safety of Nitazoxanide for the Treatment of Norovirus in Hematopoietic Stem Cell and Solid Organ Transplant Recipients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03395405
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 31 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 14, 2018
- Primary completion
- Aug 23, 2021
- Completion
- Aug 23, 2021
- Last update posted
- May 20, 2025
2018 – 2021
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northwestern University - Comprehensive Transplant Center | Chicago | Illinois | 60611-2927 | — |
| University of Kansas Medical Center - Infectious Diseases | Kansas City | Kansas | 66160-8500 | — |
| Johns Hopkins Hospital - Medicine - Infectious Diseases | Baltimore | Maryland | 21287-0005 | — |
| University of Michigan School of Public Health - Epidemiology | Ann Arbor | Michigan | 48109-2029 | — |
| University of Michigan - Infectious Disease Clinic at Taubman Center | Ann Arbor | Michigan | 48109 | — |
| University of Nebraska Medical Center - Infectious Diseases | Omaha | Nebraska | 68198-5400 | — |
| Cincinnati Children's Hospital Medical Center Vaccine Research Center | Cincinnati | Ohio | 45229-3039 | — |
| University of Pittsburgh - Medicine - Infectious Diseases | Pittsburgh | Pennsylvania | 15213-3403 | — |
| Children's Hospital of Pittsburgh of UPMC - Pediatric Infectious Diseases | Pittsburgh | Pennsylvania | 15224-1529 | — |
| University of Texas Southwestern Medical Center - Internal Medicine Subspecialties Clinic | Dallas | Texas | 75390-8884 | — |
| Fred Hutchinson Cancer Research Center - Vaccine and Infectious Diseases | Seattle | Washington | 98109-4433 | — |
| University of Washington - Medicine | Seattle | Washington | 98195-7110 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03395405, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 20, 2025 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03395405 live on ClinicalTrials.gov.