About this trial
This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Pediatric participants presenting with diarrhea and testing positive for Cryptosporidium by QuikChek™ and microscopy.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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)
Number and Percentage of Participants by Severity of Dehydration
Dehydration severity categories: * None * Some * Severe
Time to Resolution of Diarrhea and Dehydration
Secondary outcomes
Association of Diarrheal Chronicity With Age
Association of diarrheal chronicity with age will be assessed using the Kruskal-Wallis test.
Association of Diarrheal Chronicity With Height
Association of diarrheal chronicity with height will be assessed using the Kruskal-Wallis test.
Association of Diarrheal Chronicity With Weight
Association of diarrheal chronicity with weight will be assessed using the Kruskal-Wallis test.
Association of Diarrheal Chronicity With Sex
Association of diarrheal chronicity with sex will be assessed using the Fisher exact test.
Sponsors and contacts
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