Status:
NOT_YET_RECRUITING
Nitazoxanide for Treatment of Cryptosporidium in Children
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cryptosporidiosis
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to learn if nitazoxanide (NTZ) can treat Cryptosporidium infection in children age 6-12 months. The main questions it aims to answer are: * Does NTZ treatment of di...
Eligibility Criteria
Inclusion
- tests positive for Cryptosporidium by stool point-of-care test, with or without active diarrhea
- family plans on remaining in the area for next 6 months
Exclusion
- history of hypersensitivity to nitazoxanide.
- taking warfarin. Tizoxanide, the metabolite of nitazoxanide is highly bound to plasma proteins and may compete with binding sites of other highly plasma bound drugs with narrow therapeutic indices, including warfarin.
- history of renal insufficiency or a baseline serum creatinine = 40 µmol/L. Renal clearance of the drug has not been studied.
- history of hepatic dysfunction or serum aspartate aminotransferase (AST) ;
- 50 U/L, serum alanine transaminase (ATL) ;
- 50 U/L, or serum bilirubin ;
- 23 µmol/L. Hepatic clearance of the drug has not been studied.
Key Trial Info
Start Date :
January 12 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT06600711
Start Date
January 12 2026
End Date
May 1 2030
Last Update
November 24 2025
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