Cryptosporidiosis
Conditions
Keywords
Nitazoxanide
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
Interventions
DRUGNitazoxanide
5 mL suspension (100 mg), 2x/day for 3 days
DRUGPlacebo
identical in consistency, appearance, and taste to nitazoxanide suspension. 5 mL suspension given 2x/day for 3 days
Sponsors
Johns Hopkins Bloomberg School of Public Health
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days of Cryptosporidium-associated diarrhea | 7 days | — |
| Time to clearance of Cryptosporidium from stool | 6 months | Measured in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
CONTACTPoonum S Korpe, MD
PRINCIPAL_INVESTIGATORPoonum Korpe, MD
Johns Hopkins University
Outcome results
None listed