[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648099":3},{"organization":4,"outcomesModule":7,"designInfo":87,"detailedDescription":19,"studyPopulation":90,"armGroups":91,"interventions":19,"overallOfficials":95,"centralContacts":99,"locations":105,"responsibleParty":149,"collaborators":19,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":19,"eligibilityCriteria":157,"healthyVolunteers":153,"sex":158,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":19,"studyType":164,"phases":19,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":108,"whyStopped":19,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"Novartis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":19},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Number and Percentage of Participants by Chronicity of Diarrhea","Diarrhea chronicity categories:\n\n* Acute (\\\u003C7 days)\n* Prolonged (7-13 days)\n* Persistent (14-28 days)\n* Chronic (\\>28 days)","Baseline",{"measure":14,"description":15,"timeFrame":16},"Number and Percentage of Participants by Severity of Dehydration","Dehydration severity categories:\n\n* None\n* Some\n* Severe","Baseline, Days 3, 7, 14 and up to Day 21",{"measure":18,"description":19,"timeFrame":16},"Time to Resolution of Diarrhea and Dehydration",null,[21,24,27,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72,75,77,79,81,84],{"measure":22,"description":23,"timeFrame":12},"Association of Diarrheal Chronicity With Age","Association of diarrheal chronicity with age will be assessed using the Kruskal-Wallis test.",{"measure":25,"description":26,"timeFrame":12},"Association of Diarrheal Chronicity With Height","Association of diarrheal chronicity with height will be assessed using the Kruskal-Wallis test.",{"measure":28,"description":29,"timeFrame":12},"Association of Diarrheal Chronicity With Weight","Association of diarrheal chronicity with weight will be assessed using the Kruskal-Wallis test.",{"measure":31,"description":32,"timeFrame":12},"Association of Diarrheal Chronicity With Sex","Association of diarrheal chronicity with sex will be assessed using the Fisher exact test.",{"measure":34,"description":35,"timeFrame":12},"Association of Diarrheal Chronicity With HIV Status","Association of diarrheal chronicity with HIV status will be assessed using the Fisher exact test.",{"measure":37,"description":38,"timeFrame":12},"Association of Diarrheal Chronicity With Malnutrition","Association of diarrheal chronicity with malnutrition will be assessed using the Fisher exact test.",{"measure":40,"description":41,"timeFrame":12},"Association of Diarrheal Chronicity With Growth Faltering","Association of diarrheal chronicity with growth faltering will be assessed using the Fisher exact test.",{"measure":43,"description":44,"timeFrame":12},"Association of Diarrheal Chronicity With Early Weaning","Association of diarrheal chronicity with early weaning will be assessed using the Fisher exact test.",{"measure":46,"description":47,"timeFrame":12},"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.",{"measure":49,"description":50,"timeFrame":16},"Association of Dehydration Severity With Age","Association of dehydration severity with age will be assessed using the Kruskal-Wallis test.",{"measure":52,"description":53,"timeFrame":16},"Association of Dehydration Severity With Height","Association of dehydration severity with height will be assessed using the Kruskal-Wallis test.",{"measure":55,"description":56,"timeFrame":16},"Association of Dehydration Severity With Weight","Association of dehydration severity with weight will be assessed using the Kruskal-Wallis test.",{"measure":58,"description":59,"timeFrame":16},"Association of Dehydration Severity With Sex","Association of dehydration severity with sex will be assessed using the Fisher exact test.",{"measure":61,"description":62,"timeFrame":16},"Association of Dehydration Severity With HIV Status","Association of dehydration severity with HIV status will be assessed using the Fisher exact test.",{"measure":64,"description":65,"timeFrame":16},"Association of Dehydration Severity With Malnutrition","Association of dehydration severity with malnutrition will be assessed using the Fisher exact test.",{"measure":67,"description":68,"timeFrame":16},"Association of Dehydration Severity With Growth Faltering","Association of dehydration severity with growth faltering will be assessed using the Fisher exact test.",{"measure":70,"description":71,"timeFrame":16},"Association of Dehydration Severity With Early Weaning","Association of dehydration severity with early weaning will be assessed using the Fisher exact test.",{"measure":73,"description":74,"timeFrame":16},"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.",{"measure":76,"description":19,"timeFrame":16},"Number of Oocysts",{"measure":78,"description":19,"timeFrame":16},"Proportion of Participants Shedding Oocysts",{"measure":80,"description":19,"timeFrame":16},"Number of Participants by Parasite Presence Measured by Microscopy and the QuikChek™ Cryptosporidium Rapid Diagnostic Test (RDT)",{"measure":82,"description":83,"timeFrame":12},"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).",{"measure":85,"description":86,"timeFrame":12},"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).",{"allocation":19,"interventionModel":19,"interventionModelDescription":19,"primaryPurpose":19,"observationalModel":88,"timePerspective":89,"maskingInfo":19},"COHORT","PROSPECTIVE","Pediatric participants presenting with diarrhea and testing positive for Cryptosporidium by QuikChek™ and microscopy.",[92],{"label":93,"type":19,"description":94,"interventionNames":19},"Cryptosporidiosis Cohort","Pediatric participants with diarrhea due to Cryptosporidium infection.",[96],{"name":97,"affiliation":97,"role":98},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[100,104],{"name":97,"role":101,"phone":102,"phoneExt":19,"email":103},"CONTACT","+41613241111","novartis.email@novartis.com",{"name":97,"role":101,"phone":19,"phoneExt":19,"email":19},[106,120,131,139],{"facility":107,"status":108,"city":109,"state":110,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":119,"contacts":19},"Novartis Investigative Site","RECRUITING","Kisumu","Nyanza","40100","Kenya","KE",{"type":115,"coordinates":116},"Point",[117,118],34.76171,-0.10221,{"lat":118,"lon":117},{"facility":107,"status":108,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":19},"Kuantan","Pahang","25200","Malaysia","MY",{"type":115,"coordinates":127},[128,129],103.326,3.8077,{"lat":129,"lon":128},{"facility":107,"status":108,"city":132,"state":19,"zip":133,"country":124,"countryCode":125,"cosmosGeoPoint":134,"geoPoint":138,"contacts":19},"Kuala Lumpur","56000",{"type":115,"coordinates":135},[136,137],101.68653,3.1412,{"lat":137,"lon":136},{"facility":107,"status":108,"city":140,"state":19,"zip":141,"country":142,"countryCode":143,"cosmosGeoPoint":144,"geoPoint":148,"contacts":19},"Lusaka","10101","Zambia","ZM",{"type":115,"coordinates":145},[146,147],28.28713,-15.40669,{"lat":147,"lon":146},{"type":150,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100648099","a-study-to-characterize-the-clinical-presentation-and-course-of-cryptosporidium-in-pediatric-participants-100648099",false,"NCT07716410","A Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants","A Prospective Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants With Symptomatic Cryptosporidiosis in Endemic Countries","Inclusion criteria:\n\n* 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)\n* QuikChek™ and Stool microscopy positive for Cryptosporidium at screening\n* Acute (\\\u003C7 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\n* 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\n* 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\n\nExclusion criteria:\n\n* Bloody diarrhea, defined as diarrhea with visible blood in stool as observed by the study team member performing the screening or reported by parent\u002Fprimary caregiver\n* Other morbidity requiring emergency medical care in an intensive care setting at the time of screening\n* Coincident non-enteric infection including upper or lower respiratory infection at screening\n* Any participant whose parent or primary caregiver is unwilling or unable to cooperate with study procedures, in the investigator's opinion\n* If the parent\u002Fprimary 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\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","6 Months","59 Months",{"count":162,"type":163},30,"ESTIMATED","OBSERVATIONAL","This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation.",[167],"Cryptosporidiosis",[169,170,171,124,172],"Cryptosporidium","Observational","Africa","Pediatric Diarrhea","2026-07-15",{"date":175,"type":176},"2026-07-21","ACTUAL",{"date":178,"type":176},"2026-01-09",{"date":180,"type":163},"2027-05-19",{"name":97,"class":6},4]