An observational study in Cryptosporidiosis, sponsored by Novartis Pharmaceuticals. Recruiting at 4 sites in 3 countries. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation.
32 studies on the registry are indexed under Cryptosporidiosis; 6 are open to participants now.
Browse Cryptosporidiosis studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pediatric participants presenting with diarrhea and testing positive for Cryptosporidium by QuikChek™ and microscopy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric participants with diarrhea due to Cryptosporidium infection.
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)
Time frame: Baseline
Number and Percentage of Participants by Severity of Dehydration
Dehydration severity categories: * None * Some * Severe
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Time to Resolution of Diarrhea and Dehydration
Time frame: Baseline, Days 3, 7, 14 and up to Day 21
Association of Diarrheal Chronicity With Age
Association of diarrheal chronicity with age will be assessed using the Kruskal-Wallis test.
Time frame: Baseline
Association of Diarrheal Chronicity With Height
Association of diarrheal chronicity with height will be assessed using the Kruskal-Wallis test.
Time frame: Baseline
Association of Diarrheal Chronicity With Weight
Association of diarrheal chronicity with weight will be assessed using the Kruskal-Wallis test.
Time frame: Baseline
Association of Diarrheal Chronicity With Sex
Association of diarrheal chronicity with sex will be assessed using the Fisher exact test.
Time frame: Baseline
Association of Diarrheal Chronicity With HIV Status
Association of diarrheal chronicity with HIV status will be assessed using the Fisher exact test.
Time frame: Baseline
Association of Diarrheal Chronicity With Malnutrition
Association of diarrheal chronicity with malnutrition will be assessed using the Fisher exact test.
Time frame: Baseline
Association of Diarrheal Chronicity With Growth Faltering
Association of diarrheal chronicity with growth faltering will be assessed using the Fisher exact test.
Time frame: Baseline
Association of Diarrheal Chronicity With Early Weaning
Association of diarrheal chronicity with early weaning will be assessed using the Fisher exact test.
Time frame: 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.
Time frame: Baseline
Association of Dehydration Severity With Age
Association of dehydration severity with age will be assessed using the Kruskal-Wallis test.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Number of participants screened (i.e., present with diarrheal illness) for each site by time of year (i.e., per season).
Time frame: 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).
Time frame: Baseline
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for May 2027, 16 months after the start.
How these figures are worked out, and which studies are left out of them.
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