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Nitazoxanide for Treatment of Cryptosporidium in Children

NCT06600711 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2026-04-17

No results posted yet for this study

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

Interventions

DRUG

Nitazoxanide

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

DRUG

Placebo

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Poonum Korpe, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-12-31
Completion
2030-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06600711 on ClinicalTrials.gov