A Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants

NCT07716410 | Recruiting

• 1 other identifier: CMTHDLGY0031
• Study Type: observational
• Target: 30
• Locations: 3 countries
• Sites: 4

Brief Summary

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

Conditions

Cryptosporidiosis

Keywords

Cryptosporidium; Observational; Africa; Malaysia; Pediatric Diarrhea

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (23)

• Association of Diarrheal Chronicity With Age

  Baseline

• Association of Diarrheal Chronicity With Height

  Baseline

• Association of Diarrheal Chronicity With Weight

  Baseline

• Association of Diarrheal Chronicity With Sex

  Baseline

• Association of Diarrheal Chronicity With HIV Status

  Baseline

Study Arms (1)

Cryptosporidiosis Cohort

Pediatric participants with diarrhea due to Cryptosporidium infection.

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Novartis Investigative Site

Kisumu, Nyanza, 40100, Kenya

RECRUITING

Novartis Investigative Site

Kuantan, Pahang, 25200, Malaysia

RECRUITING

Novartis Investigative Site

Kuala Lumpur, 56000, Malaysia

RECRUITING

Novartis Investigative Site

Lusaka, 10101, Zambia

RECRUITING

MeSH Terms

Conditions

Cryptosporidiosis

Condition Hierarchy (Ancestors)

Intestinal Diseases, Parasitic; Parasitic Diseases; Infections; Protozoan Infections, Animal; Parasitic Diseases, Animal; Coccidiosis; Protozoan Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Animal Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 21, 2026
• Study Start: January 9, 2026
• Primary Completion (Estimated): May 19, 2027
• Study Completion (Estimated): May 19, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1); MY (2); KE (1)