Nitazoxanide for Treatment of Cryptosporidium in Children

Launched by JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH · Sep 16, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called nitazoxanide (NTZ) can help treat infections caused by a parasite called Cryptosporidium in children aged 6 to 12 months. The main goals of the study are to see if NTZ can reduce the number of days children have diarrhea and if it can also lower the number of days the parasites can be found in their stool. To find out if NTZ works, researchers will compare it to a placebo, which is an inactive look-alike treatment.

To be eligible for this trial, children must test positive for Cryptosporidium, whether or not they currently have diarrhea, and their families need to plan to stay in the area for the next six months. Participants will take NTZ or the placebo for three days, have regular visits from research staff, and provide samples of blood and urine. It’s important to note that children with certain health conditions, such as allergies to nitazoxanide or problems with their kidneys or liver, will not be able to participate. This study is not yet recruiting participants but is a valuable step towards finding effective treatments for this infection.

Gender

ALL

Eligibility criteria

• 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.