Nitazoxanide for Treatment of Cryptosporidium in Children

NCT ID: NCT06600711

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-12
• Study Completion Date: 2030-05-31

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 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

Conditions

Cryptosporidiosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nitazoxanide

Group Type: EXPERIMENTAL

Nitazoxanide

Intervention Type: DRUG

5 mL suspension (100 mg), 2x/day for 3 days

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

identical in consistency, appearance, and taste to nitazoxanide suspension. 5 mL suspension given 2x/day for 3 days

Interventions

Nitazoxanide

5 mL suspension (100 mg), 2x/day for 3 days

Intervention Type: DRUG

Placebo

identical in consistency, appearance, and taste to nitazoxanide suspension. 5 mL suspension given 2x/day for 3 days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Poonum Korpe, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Central Contacts

Poonum S Korpe, MD

Role: CONTACT

pkorpe1@jhu.edu

7037254821

Other Identifiers

U01AI167788-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00024940

Identifier Type: -

Identifier Source: org_study_id