CryptosporidiosisNCT07716410
A Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants
An observational study of Cryptosporidiosis, run by Novartis Pharmaceuticals at 4 sites in 3 countries.
Trial summary
This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Cryptosporidiosis
- How many people
- 30 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 9 Jan 2026to 19 May 2027
- Phase
- Observational
- 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 59 months
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric participants presenting with diarrhea and testing positive for Cryptosporidium by QuikChek™ and microscopy.
Who may be able to join
- Age 6 months to 59 months with diarrhea according to the World Health Organization (WHO) criteria (≥3 loose stools daily for at least 2 days)
- QuikChek™ and Stool microscopy positive for Cryptosporidium at screening
- Acute (<7 days), prolonged (lasting 7-13 days), persistent (lasting 14-28 days) or chronic (lasting >28 days) diarrheal illness (≥3 loose stools daily, as defined by WHO) at screening
- Normal nutritional status, mildly-to-moderately acutely malnourished, or severely acutely malnourished according to WHO definitions (number of participants with severe acute malnutrition will be capped) at screening
- Parent or primary caregiver is willing to provide informed consent and to comply with study procedures, including provision of whole stool samples at the scheduled time points and willing to be followed up to 21 days
Who cannot join
- Bloody diarrhea, defined as diarrhea with visible blood in stool as observed by the study team member performing the screening or reported by parent/primary caregiver
- Other morbidity requiring emergency medical care in an intensive care setting at the time of screening
- Coincident non-enteric infection including upper or lower respiratory infection at screening
- Any participant whose parent or primary caregiver is unwilling or unable to cooperate with study procedures, in the investigator's opinion
- If the parent/primary caregiver managing care of the patient has travel plans out of the study area that would preclude clinic or in-home study visits during the expected study follow-up period
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
4 sites in 3 countries
Malaysia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Kuala Lumpur, 56000
- Recruiting
Novartis Investigative Site
Kuantan, Pahang, 25200
Kenya1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Kisumu, Nyanza, 40100
About this study
Official title: A Prospective Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants With Symptomatic Cryptosporidiosis in Endemic Countries
This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation.
- Conditions
- Cryptosporidiosis
- Keywords
- Cryptosporidium, Observational, Africa, Malaysia, Pediatric Diarrhea
- Medical subject headings
- Cryptosporidiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cryptosporidiosis Cohort | Pediatric participants with diarrhea due to Cryptosporidium infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Participants by Chronicity of Diarrhea
Diarrhea chronicity categories:
- Acute (<7 days)
- Prolonged (7-13 days)
- Persistent (14-28 days)
- Chronic (>28 days)
Measured: Baseline
Number and Percentage of Participants by Severity of Dehydration
Dehydration severity categories:
- None
- Some
- Severe
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Time to Resolution of Diarrhea and Dehydration
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Secondary outcomes (23)
Association of Diarrheal Chronicity With Age
Association of diarrheal chronicity with age will be assessed using the Kruskal-Wallis test.
Measured: Baseline
Association of Diarrheal Chronicity With Height
Association of diarrheal chronicity with height will be assessed using the Kruskal-Wallis test.
Measured: Baseline
Association of Diarrheal Chronicity With Weight
Association of diarrheal chronicity with weight will be assessed using the Kruskal-Wallis test.
Measured: Baseline
Association of Diarrheal Chronicity With Sex
Association of diarrheal chronicity with sex will be assessed using the Fisher exact test.
Measured: Baseline
Association of Diarrheal Chronicity With HIV Status
Association of diarrheal chronicity with HIV status will be assessed using the Fisher exact test.
Measured: Baseline
Association of Diarrheal Chronicity With Malnutrition
Association of diarrheal chronicity with malnutrition will be assessed using the Fisher exact test.
Measured: Baseline
Association of Diarrheal Chronicity With Growth Faltering
Association of diarrheal chronicity with growth faltering will be assessed using the Fisher exact test.
Measured: Baseline
Association of Diarrheal Chronicity With Early Weaning
Association of diarrheal chronicity with early weaning will be assessed using the Fisher exact test.
Measured: Baseline
Association of Diarrheal Chronicity With Non-Exclusive Breast Feeding
Association of diarrheal chronicity with early non-exclusive breast feeding will be assessed using the Fisher exact test.
Measured: Baseline
Association of Dehydration Severity With Age
Association of dehydration severity with age will be assessed using the Kruskal-Wallis test.
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Height
Association of dehydration severity with height will be assessed using the Kruskal-Wallis test.
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Weight
Association of dehydration severity with weight will be assessed using the Kruskal-Wallis test.
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Sex
Association of dehydration severity with sex will be assessed using the Fisher exact test.
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With HIV Status
Association of dehydration severity with HIV status will be assessed using the Fisher exact test.
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Malnutrition
Association of dehydration severity with malnutrition will be assessed using the Fisher exact test.
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Growth Faltering
Association of dehydration severity with growth faltering will be assessed using the Fisher exact test.
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Early Weaning
Association of dehydration severity with early weaning will be assessed using the Fisher exact test.
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Non-Exclusive Breast Feeding
Association of dehydration severity with early non-exclusive breast feeding will be assessed using the Fisher exact test.
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Number of Oocysts
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Proportion of Participants Shedding Oocysts
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Number of Participants by Parasite Presence Measured by Microscopy and the QuikChek™ Cryptosporidium Rapid Diagnostic Test (RDT)
Measured: Baseline, Days 3, 7, 14 and up to Day 21
Number of Participants Screened for Each Site by Time of Year
Number of participants screened (i.e., present with diarrheal illness) for each site by time of year (i.e., per season).
Measured: Baseline
Number of Participants Enrolled for Each Site by Time of Year
Number of participants enrolled (i.e., Cryptosporidium positive) for each site by time of year (i.e., per season).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start9 Jan 2026
- Primary completion19 May 2027 (estimated)
- Study completion19 May 2027 (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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716410
- Sponsor's protocol ID
- CMTHDLGY0031
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants With Symptomatic Cryptosporidiosis in Endemic Countries
- ClinicalTrials.gov ID
- NCT07716410
- Acronym / sponsor ID
- CMTHDLGY0031
- Conditions
- Cryptosporidiosis
- Keywords
- Cryptosporidium, Observational, Africa, Malaysia, Pediatric Diarrhea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 19 May 2027 (estimated)
- Study completion
- 19 May 2027 (estimated)
- First posted
- 21 Jul 2026 (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.
This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryptosporidiosis Cohort | – | –Pediatric participants with diarrhea due to Cryptosporidium infection. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric participants presenting with diarrhea and testing positive for Cryptosporidium by QuikChek™ and microscopy.
Key inclusion criteria (5 listed)
- Age 6 months to 59 months with diarrhea according to the World Health Organization (WHO) criteria (≥3 loose stools daily for at least 2 days)
- QuikChek™ and Stool microscopy positive for Cryptosporidium at screening
- Acute (<7 days), prolonged (lasting 7-13 days), persistent (lasting 14-28 days) or chronic (lasting >28 days) diarrheal illness (≥3 loose stools daily, as defined by WHO) at screening
- Normal nutritional status, mildly-to-moderately acutely malnourished, or severely acutely malnourished according to WHO definitions (number of participants with severe acute malnutrition will be capped) at screening
- Parent or primary caregiver is willing to provide informed consent and to comply with study procedures, including provision of whole stool samples at the scheduled time points and willing to be followed up to 21 days
Key exclusion criteria (6 listed)
- Bloody diarrhea, defined as diarrhea with visible blood in stool as observed by the study team member performing the screening or reported by parent/primary caregiver
- Other morbidity requiring emergency medical care in an intensive care setting at the time of screening
- Coincident non-enteric infection including upper or lower respiratory infection at screening
- Any participant whose parent or primary caregiver is unwilling or unable to cooperate with study procedures, in the investigator's opinion
- If the parent/primary caregiver managing care of the patient has travel plans out of the study area that would preclude clinic or in-home study visits during the expected study follow-up period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number and Percentage of Participants by Chronicity of Diarrhea
Time frame: Baseline
Diarrhea chronicity categories: * Acute (<7 days) * Prolonged (7-13 days) * Persistent (14-28 days) * Chronic (>28 days)
Number and Percentage of Participants by Severity of Dehydration
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Dehydration severity categories: * None * Some * Severe
Time to Resolution of Diarrhea and Dehydration
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
23 secondary outcomes
Association of Diarrheal Chronicity With Age
Time frame: Baseline
Association of Diarrheal Chronicity With Height
Time frame: Baseline
Association of Diarrheal Chronicity With Weight
Time frame: Baseline
Association of Diarrheal Chronicity With Sex
Time frame: Baseline
Association of Diarrheal Chronicity With HIV Status
Time frame: Baseline
Association of Diarrheal Chronicity With Malnutrition
Time frame: Baseline
Association of Diarrheal Chronicity With Growth Faltering
Time frame: Baseline
Association of Diarrheal Chronicity With Early Weaning
Time frame: Baseline
Association of Diarrheal Chronicity With Non-Exclusive Breast Feeding
Time frame: Baseline
Association of Dehydration Severity With Age
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Height
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Weight
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Sex
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With HIV Status
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Malnutrition
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Growth Faltering
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Early Weaning
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Non-Exclusive Breast Feeding
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Number of Oocysts
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Proportion of Participants Shedding Oocysts
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Number of Participants by Parasite Presence Measured by Microscopy and the QuikChek™ Cryptosporidium Rapid Diagnostic Test (RDT)
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Number of Participants Screened for Each Site by Time of Year
Time frame: Baseline
Number of Participants Enrolled for Each Site by Time of Year
Time frame: Baseline
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 21 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryptosporidiosis, run by Novartis Pharmaceuticals at 4 sites in 3 countries.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Malaysia, Kenya, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Percentage of Participants by Chronicity of Diarrhea (time frame: Baseline). The study lists 3 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 21 Jul 2026.