NNITS-Nitazoxanide for Norovirus in Transplant Patients Study

This is an interventional treatment trial for Gastroenteritis Norovirus focused on measuring Efficacy, Hematopoietic Stem Cell, Nitazoxanide, Norovirus, Prospective, Randomized, Double-Blind Study, Safety, Solid Organ Transplant Recipients, Treatment Read More

Inclusion Criteria:

Subjects should meet all of the following inclusion criteria:

1. Male or female age > / = 12 years.
2. Recipient of a solid organ or hematopoietic stem cell transplant.
3. Positive test result for Norovirus within 14 days of enrollment that is obtained as part of routine clinical care using a Norovirus testing available to the site.
4. Active GI symptoms (diarrhea, or vomiting) that, in the opinion of the PI, are secondary to Norovirus. Patients must have active diarrhea, which is defined as at least 3 days of Bristol 6 or 7 stools in the past 2 weeks prior to enrollment per patient report.
5. Willing and able to provide written informed consent and assent before initiation of any study procedures, consistent with local IRB policy.

6. Subjects must be of non-childbearing potential or if of childbearing potential, must be using an effective method of birth control or must be abstinent.

   • Non-childbearing potential is defined as surgically sterile or postmenopausal for > one year.
   • Effective methods of birth control include the use of hormonal or barrier birth control such as implants, injectable contraceptives, combined oral contraceptives, intrauterine devices (IUDs),or condoms with spermicidal agents during study period. Female subjects must be using an effective method of birth control or practice abstinence and must agree to continue such precautions during the study and for 30 days after the Day 28 study visit.
   • A woman is eligible if she is monogamous with a vasectomized male.This subject is considered low risk and not required to use contraception.
7. Agrees to complete all screening requirements, study visits and procedures.

Exclusion Criteria:

Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:

1. Other identified infectious causes of diarrhea at screening. Alternative diagnosis requiring treatment would be considered a co-infection; if the testing is positive for a pathogen that the PI does not feel is causing the symptoms, they may be included but the PI or his/her designee must document that the positive test is not clinically significant, does not require treatment and is not causing the symptoms making the patient eligible for enrollment.
2. Any condition that would, in opinion of the Site Investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
3. Subjects receiving oral or intravenous immunoglobulin therapy concurrently or in the 14 days prior to enrollment.
4. Nitazoxanide use for any illness in the previous 30 days prior to randomization.
5. Have received experimental products within 30 days prior to the study entry or plan to receive experimental products at any time during the study
6. Known sensitivity to nitazoxanide or any of the excipients comprising the nitazoxanide tablets.
7. Subjects unable to swallow oral medications.
8. Subjects with ostomy.
9. Women who are pregnant or lactating or have a positive urine pregnancy test at screening/enrollment/Day 1.