Nitazoxanide for Treatment of Cryptosporidium in Children
- Registration Number
- NCT06600711
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 480
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nitazoxanide Nitazoxanide - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Days of Cryptosporidium-associated diarrhea 7 days Time to clearance of Cryptosporidium from stool 6 months Measured in days
- Secondary Outcome Measures
Name Time Method Adverse events, total and stratified by age 6 months Time-to-first Cryptosporidium infection in sibling 6 months Measured in days
Change in weight from baseline to 6 months post-treatment Baseline, 6 months Weight measured in kilograms
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 Measured in centimeters