Nitazoxanide for Treatment of Cryptosporidium in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nitazoxanide, Placebo.
- Who it may be relevant to
- Registry conditions: Cryptosporidiosis. Basic parameters: 6 months — 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Control Trial of Nitazoxanide for the Treatment of Cryptosporidium Infection in Malnourished Children in Bangladesh
Overview
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
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
Primary outcome measures
- Days of Cryptosporidium-associated diarrhea [Time frame: 7 days]
- Time to clearance of Cryptosporidium from stool [Time frame: 6 months]
Secondary outcome measures (5)
- Adverse events, total and stratified by age [Time frame: 6 months]
- Time-to-first Cryptosporidium infection in sibling [Time frame: 6 months]
- Change in weight from baseline to 6 months post-treatment [Time frame: Baseline, 6 months]
- Change in Lactulose:Mannitol ratio from baseline to 6 months post treatment [Time frame: Baseline, 6 months]
- Change in height-for-age adjusted z-score from baseline to 6 months post treatment [Time frame: Baseline, 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06600711 · IRB00024940 · U01AI167788-01A1