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Not yet recruiting Phase 3 NCT06600711

Nitazoxanide for Treatment of Cryptosporidium in Children

Phase 3 – large-scale trial before approval
Conditions: Cryptosporidiosis

Sponsor: Johns Hopkins Bloomberg School of Public Health

trial.available_in: БГ
Overview
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 diarrheal Cryptosporidium infection lower the number of days of diarrhea? * Does NTZ treatment of diarrheal and non-diarrheal Cryptosporidium infection lower the number of days that parasites can be found in the stool? Researchers will compare NTZ to a placebo (a look-alike substance that contains no drug) to see if NTZ works to treat Cryptosporidium. Participants will: * Take NTZ or placebo for 3 days * Receive regular visits from field research assistants * Provide blood and urine samples
Who can participate
Inclusion Criteria: * 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 Criteria: * 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.
Interventions
Nitazoxanide
DRUG
Placebo
DRUG
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
6 Months
Maximum age
12 Months
Healthy volunteers
No
Start date
30.06.2026
Completion date
01.05.2030
Registry ID
NCT06600711
Source
clinicaltrials.gov
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