Nitazoxanide for Treatment of Cryptosporidium in Children
ConditionCryptosporidiosis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-12
SponsorJohns Hopkins Bloomberg School of Public Health
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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) ;
Trial design
Treatments tested in this trial
- Nitazoxanide
- Placebo
Treatment groups
480 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Johns Hopkins Bloomberg School of Public Health
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov