Nitazoxanide for Treatment of Cryptosporidium in Children (NCT06600711) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Nitazoxanide for Treatment of Cryptosporidium in Children
480 participantsStarted 2026-06-30
Plain-language 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
Who can participate
Age range
6 Months – 12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Days of Cryptosporidium-associated diarrhea
Timeframe: 7 days
2
Time to clearance of Cryptosporidium from stool
Timeframe: 6 months
Trial details
NCT IDNCT06600711
SponsorJohns Hopkins Bloomberg School of Public Health