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

This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation.

Study Overview

• Status: Recruiting
• Conditions: Cryptosporidiosis

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Kenya
  • Nyanza
    • Kisumu, Nyanza, Kenya, 40100
      • Recruiting
      • Novartis Investigative Site
• Malaysia
  • Kuala Lumpur, Malaysia, 56000
    • Recruiting
    • Novartis Investigative Site
  • Pahang
    • Kuantan, Pahang, Malaysia, 25200
      • Recruiting
      • Novartis Investigative Site
• Zambia
  • Lusaka, Zambia, 10101
    • Recruiting
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric participants presenting with diarrhea and testing positive for Cryptosporidium by QuikChek™ and microscopy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cryptosporidiosis Cohort; Pediatric participants with diarrhea due to Cryptosporidium infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline
Number and Percentage of Participants by Severity of Dehydration	Dehydration severity categories: None; Some; Severe	Baseline, Days 3, 7, 14 and up to Day 21
Time to Resolution of Diarrhea and Dehydration		Baseline, Days 3, 7, 14 and up to Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of Diarrheal Chronicity With Age	Association of diarrheal chronicity with age will be assessed using the Kruskal-Wallis test.	Baseline
Association of Diarrheal Chronicity With Height	Association of diarrheal chronicity with height will be assessed using the Kruskal-Wallis test.	Baseline
Association of Diarrheal Chronicity With Weight	Association of diarrheal chronicity with weight will be assessed using the Kruskal-Wallis test.	Baseline
Association of Diarrheal Chronicity With Sex	Association of diarrheal chronicity with sex will be assessed using the Fisher exact test.	Baseline
Association of Diarrheal Chronicity With HIV Status	Association of diarrheal chronicity with HIV status will be assessed using the Fisher exact test.	Baseline
Association of Diarrheal Chronicity With Malnutrition	Association of diarrheal chronicity with malnutrition will be assessed using the Fisher exact test.	Baseline
Association of Diarrheal Chronicity With Growth Faltering	Association of diarrheal chronicity with growth faltering will be assessed using the Fisher exact test.	Baseline
Association of Diarrheal Chronicity With Early Weaning	Association of diarrheal chronicity with early weaning will be assessed using the Fisher exact test.	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.	Baseline
Association of Dehydration Severity With Age	Association of dehydration severity with age will be assessed using the Kruskal-Wallis test.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline, Days 3, 7, 14 and up to Day 21
Number of Oocysts		Baseline, Days 3, 7, 14 and up to Day 21
Proportion of Participants Shedding Oocysts		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)		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).	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).	Baseline

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2026
• Primary Completion (Estimated): May 19, 2027
• Study Completion (Estimated): May 19, 2027

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Observational; Africa; Malaysia; Cryptosporidium; Pediatric Diarrhea
• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Protozoan Infections; Parasitic Diseases; Intestinal Diseases, Parasitic; Protozoan Infections, Animal; Parasitic Diseases, Animal; Coccidiosis; Animal Diseases; Cryptosporidiosis
• Other Study ID Numbers: CMTHDLGY0031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO