Nitazoxanide for Treatment of Cryptosporidium in Children

Randomized Control Trial of Nitazoxanide for the Treatment of Cryptosporidium Infection in Malnourished Children in Bangladesh

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cryptosporidiosis
• Intervention / Treatment: Drug: Nitazoxanide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Poonum S Korpe, MD; Phone Number: 7037254821; Email: pkorpe1@jhu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; identical in consistency, appearance, and taste to nitazoxanide suspension. 5 mL suspension given 2x/day for 3 days
Experimental: Nitazoxanide	Drug: Nitazoxanide; 5 mL suspension (100 mg), 2x/day for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of Cryptosporidium-associated diarrhea		7 days
Time to clearance of Cryptosporidium from stool	Measured in days	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events, total and stratified by age		6 months
Time-to-first Cryptosporidium infection in sibling	Measured in days	6 months
Change in weight from baseline to 6 months post-treatment	Weight measured in kilograms	Baseline, 6 months
Change in Lactulose:Mannitol ratio from baseline to 6 months post treatment		Baseline, 6 months
Change in height-for-age adjusted z-score from baseline to 6 months post treatment	Measured in centimeters	Baseline, 6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Poonum Korpe, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Nitazoxanide
• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Protozoan Infections; Parasitic Diseases; Intestinal Diseases, Parasitic; Protozoan Infections, Animal; Parasitic Diseases, Animal; Coccidiosis; Animal Diseases; Cryptosporidiosis; Anti-Infective Agents; Antiparasitic Agents; nitazoxanide
• Other Study ID Numbers: IRB00024940; U01AI167788-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No