Phase II Multi-Center, Prospective, Randomized, Double-Blind Study of Nitazoxanide in Acute and Chronic Norovirus in Hematpoietic Stem Cell and Solid Organ Transplant Recipients

The Offeror proposes a phase II multi-center, prospective, randomized, double-blind study to assess the clinical and antiviral efficacy and safety of nitazoxanide for the treatment of acute and chronic norovirus in hematopoietic stem cell and solid organ transplant recipients. Randomization will be stratified by acuity of norovirus-associated symptoms (diarrhea, vomiting and/or decreased appetite; <14 days or ≥14 days since onset), transplant type (solid organ vs. hematopoietic stem cell) and age (pediatric (1-18 years) vs. adult (>18 years). The study hopes to address the following key aims: 1. To assess the clinical and virologic efficacy of nitazoxanide for the management of acute and chronic norovirus in transplant recipients 2. To assess the safety of nitazoxanide for the management of acute and chronic norovirus in transplant recipients 3. To assess patient- and virus-specific change over time that may be associated with clinical and virologic response to nitazoxanide