Nitazoxanide for Treatment of Cryptosporidium in Children

Johns Hopkins Bloomberg School of Public Health

Status and phase

Not yet enrolling

Phase 3

Conditions

Cryptosporidiosis

Treatments

Drug: Placebo

Drug: Nitazoxanide

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06600711

IRB00024940

U01AI167788-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment

480 estimated patients

Sex

All

Ages

6 to 12 months old

Volunteers

No Healthy Volunteers

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.