A Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Part… (NCT07716410) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants
Kenya, Malaysia, Zambia30 participantsStarted 2026-01-09
Plain-language summary
This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation.
Who can participate
Age range
6 Months – 59 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* 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
Exclusion criteria:
* 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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and Percentage of Participants by Chronicity of Diarrhea
Timeframe: Baseline
2
Number and Percentage of Participants by Severity of Dehydration
Timeframe: Baseline, Days 3, 7, 14 and up to Day 21
3
Time to Resolution of Diarrhea and Dehydration
Timeframe: Baseline, Days 3, 7, 14 and up to Day 21