Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Nitazoxanide

    Drug

    5 mL suspension (100 mg), 2x/day for 3 days

  • Placebo

    Drug

    identical in consistency, appearance, and taste to nitazoxanide suspension. 5 mL suspension given 2x/day for 3 days

Treatment groups

480 Participants
are divided into 2 treatment groups
Group A: NitazoxanideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Days of Cryptosporidium-associated diarrhea

Time frame
7 days
2

Time to clearance of Cryptosporidium from stool

Measured in days

Time frame
6 months

Secondary outcomes

1

Adverse events, total and stratified by age

Time frame
6 months
2

Time-to-first Cryptosporidium infection in sibling

Measured in days

Time frame
6 months
3

Change in weight from baseline to 6 months post-treatment

Weight measured in kilograms

Time frame
Baseline, 6 months
4

Change in Lactulose:Mannitol ratio from baseline to 6 months post treatment

Time frame
Baseline, 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins Bloomberg School of Public Health

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: