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NCT Number: NCT06600711

Nitazoxanide for Treatment of Cryptosporidium in Children

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

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Key information

Conditions

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

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nitazoxanide

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Days of Cryptosporidium-associated diarrhea

    Time frame: 7 days

  2. Time to clearance of Cryptosporidium from stool

    Time frame: 6 months

    Measured in days

Secondary outcomes

  1. Adverse events, total and stratified by age

    Time frame: 6 months

  2. Time-to-first Cryptosporidium infection in sibling

    Time frame: 6 months

    Measured in days

  3. Change in weight from baseline to 6 months post-treatment

    Time frame: Baseline, 6 months

    Weight measured in kilograms

  4. Change in Lactulose:Mannitol ratio from baseline to 6 months post treatment

    Time frame: Baseline, 6 months

  5. Change in height-for-age adjusted z-score from baseline to 6 months post treatment

    Time frame: Baseline, 6 months

    Measured in centimeters

Study contacts

Contact information is provided by the study sponsor or research team.

Poonum S Korpe, MD

CONTACT

[email protected]

7037254821

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Sep 19, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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