CryptosporidiosisPhase 3NCT06600711
Nitazoxanide for Treatment of Cryptosporidium in Children
A Phase 3 study testing Nitazoxanide in people with Cryptosporidiosis, run by Johns Hopkins Bloomberg School of Public Health.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 months
- Conditions the study is for
- Cryptosporidiosis
- What is being tested?
- Nitazoxanide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2026to May 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Control Trial of Nitazoxanide for the Treatment of Cryptosporidium Infection in Malnourished Children in Bangladesh
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
- Conditions
- Cryptosporidiosis
- Being tested
- Nitazoxanide, Placebo
- Keywords
- Nitazoxanide
- Medical subject headings
- Cryptosporidiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
5 mL suspension (100 mg), 2x/day for 3 days
PlaceboDrug
identical in consistency, appearance, and taste to nitazoxanide suspension. 5 mL suspension given 2x/day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide | Experimental | Not described Receives: Drug: Nitazoxanide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of Cryptosporidium-associated diarrhea
Measured: 7 days
Time to clearance of Cryptosporidium from stool
Measured in days
Measured: 6 months
Secondary outcomes (5)
Adverse events, total and stratified by age
Measured: 6 months
Time-to-first Cryptosporidium infection in sibling
Measured in days
Measured: 6 months
Change in weight from baseline to 6 months post-treatment
Weight measured in kilograms
Measured: Baseline, 6 months
Change in Lactulose:Mannitol ratio from baseline to 6 months post treatment
Measured: Baseline, 6 months
Change in height-for-age adjusted z-score from baseline to 6 months post treatment
Measured in centimeters
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Dec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryptosporidiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Poonum Korpe, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600711
- Sponsor's protocol ID
- IRB00024940
- Other IDs
- U01AI167788-01A1
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Nitazoxanide for the Treatment of Cryptosporidium Infection in Malnourished Children in Bangladesh
- ClinicalTrials.gov ID
- NCT06600711
- Acronym / sponsor ID
- IRB00024940
- Conditions
- Cryptosporidiosis
- Keywords
- Nitazoxanide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide | Experimental | Drug: Nitazoxanide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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) ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitazoxanide5 mL suspension (100 mg), 2x/day for 3 days | Drug | Nitazoxanide |
| Placeboidentical in consistency, appearance, and taste to nitazoxanide suspension. 5 mL suspension given 2x/day for 3 days | Drug | Placebo |
Primary outcome
Days of Cryptosporidium-associated diarrhea
Time frame: 7 days
Time to clearance of Cryptosporidium from stool
Time frame: 6 months
Measured in days
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Poonum Korpe, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitazoxanide in people with Cryptosporidiosis, run by Johns Hopkins Bloomberg School of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Poonum S Korpe, MD (7037254821, pkorpe1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of Cryptosporidium-associated diarrhea (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.