Status:
COMPLETED
NNITS-Nitazoxanide for Norovirus in Transplant Patients Study
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Gastroenteritis Norovirus
Eligibility:
All Genders
12-99 years
Phase:
PHASE2
Brief 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 wit...
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 wit...
Eligibility Criteria
Inclusion
- Subjects should meet all of the following inclusion criteria:
- Male or female age \> / = 12 years.
- Recipient of a solid organ or hematopoietic stem cell transplant.
- 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.
- 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.
- Willing and able to provide written informed consent and assent before initiation of any study procedures, consistent with local IRB policy.
- 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.
- Agrees to complete all screening requirements, study visits and procedures.
Exclusion
- Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:
- 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.
- 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.
- Subjects receiving oral or intravenous immunoglobulin therapy concurrently or in the 14 days prior to enrollment.
- Nitazoxanide use for any illness in the previous 30 days prior to randomization.
- Have received experimental products within 30 days prior to the study entry or plan to receive experimental products at any time during the study
- Known sensitivity to nitazoxanide or any of the excipients comprising the nitazoxanide tablets.
- Subjects unable to swallow oral medications.
- Subjects with ostomy.
- Women who are pregnant or lactating or have a positive urine pregnancy test at screening/enrollment/Day 1.
Key Trial Info
Start Date :
October 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03395405
Start Date
October 15 2018
End Date
August 24 2021
Last Update
May 21 2025
Active Locations (12)
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1
Northwestern University - Comprehensive Transplant Center
Chicago, Illinois, United States, 60611-2927
2
University of Kansas Medical Center - Infectious Diseases
Kansas City, Kansas, United States, 66160-8500
3
Johns Hopkins Hospital - Medicine - Infectious Diseases
Baltimore, Maryland, United States, 21287-0005
4
University of Michigan School of Public Health - Epidemiology
Ann Arbor, Michigan, United States, 48109-2029