Nitazoxanide for Treatment of Cryptosporidium in Children

NCT06600711 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: IRB00024940U01AI167788-01A1
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

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

Keywords

Nitazoxanide

Outcome Measures

Primary Outcomes (2)

• Days of Cryptosporidium-associated diarrhea

  7 days

• Time to clearance of Cryptosporidium from stool

  Measured in days

  6 months

Secondary Outcomes (5)

• Adverse events, total and stratified by age

  6 months

• Time-to-first Cryptosporidium infection in sibling

  6 months

• Change in weight from baseline to 6 months post-treatment

  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

  Baseline, 6 months

Study Arms (2)

Nitazoxanide

EXPERIMENTAL

Drug: Nitazoxanide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Nitazoxanide DRUG

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

Nitazoxanide

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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) ;
• U/L, serum alanine transaminase (ATL) ;
• U/L, or serum bilirubin ;
• µmol/L. Hepatic clearance of the drug has not been studied.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

MeSH Terms

Conditions

Cryptosporidiosis

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Intestinal Diseases, Parasitic; Parasitic Diseases; Infections; Protozoan Infections, Animal; Parasitic Diseases, Animal; Coccidiosis; Protozoan Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Animal Diseases

Study Officials

• Poonum Korpe, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Poonum S Korpe, MD

CONTACT

7037254821; pkorpe1@jhu.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04