Understanding how Cryptosporidium shows up in kids with diarrhea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study enrolls children aged 6 months to 59 months who have diarrhea and test positive for Cryptosporidium. It aims to describe clinical signs, symptoms, and the course of illness over time in pediatric patients. Data collection includes stool samples and follow-up up to 21 days to capture the illness trajectory. No intervention is randomized or experimental beyond observational monitoring.

Why it matters

Who can join: the full rules

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 that would preclude clinic or in-home study visits during the expected study follow-up period

Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• Novartis Investigative Site
  Kisumu, Nyanza, Kenya Recruiting
• Novartis Investigative Site
  Kuantan, Pahang, Malaysia Recruiting
• Novartis Investigative Site
  Kuala Lumpur, Malaysia Recruiting
• Novartis Investigative Site
  Lusaka, Zambia Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.