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NCT Number: NCT07716410

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

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

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Key information

Conditions

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

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Kisumu, Nyanza, Kenya

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number and Percentage of Participants by Chronicity of Diarrhea

    Time frame: Baseline

    Diarrhea chronicity categories:

    • Acute (<7 days)
    • Prolonged (7-13 days)
    • Persistent (14-28 days)
    • Chronic (>28 days)

  2. Number and Percentage of Participants by Severity of Dehydration

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

    Dehydration severity categories:

    • None
    • Some
    • Severe

  3. Time to Resolution of Diarrhea and Dehydration

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

Secondary outcomes

  1. Association of Diarrheal Chronicity With Age

    Time frame: Baseline

    Association of diarrheal chronicity with age will be assessed using the Kruskal-Wallis test.

  2. Association of Diarrheal Chronicity With Height

    Time frame: Baseline

    Association of diarrheal chronicity with height will be assessed using the Kruskal-Wallis test.

  3. Association of Diarrheal Chronicity With Weight

    Time frame: Baseline

    Association of diarrheal chronicity with weight will be assessed using the Kruskal-Wallis test.

  4. Association of Diarrheal Chronicity With Sex

    Time frame: Baseline

    Association of diarrheal chronicity with sex will be assessed using the Fisher exact test.

  5. Association of Diarrheal Chronicity With HIV Status

    Time frame: Baseline

    Association of diarrheal chronicity with HIV status will be assessed using the Fisher exact test.

  6. Association of Diarrheal Chronicity With Malnutrition

    Time frame: Baseline

    Association of diarrheal chronicity with malnutrition will be assessed using the Fisher exact test.

  7. Association of Diarrheal Chronicity With Growth Faltering

    Time frame: Baseline

    Association of diarrheal chronicity with growth faltering will be assessed using the Fisher exact test.

  8. Association of Diarrheal Chronicity With Early Weaning

    Time frame: Baseline

    Association of diarrheal chronicity with early weaning will be assessed using the Fisher exact test.

  9. Association of Diarrheal Chronicity With Non-Exclusive Breast Feeding

    Time frame: Baseline

    Association of diarrheal chronicity with early non-exclusive breast feeding will be assessed using the Fisher exact test.

  10. Association of Dehydration Severity With Age

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

    Association of dehydration severity with age will be assessed using the Kruskal-Wallis test.

  11. Association of Dehydration Severity With Height

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

    Association of dehydration severity with height will be assessed using the Kruskal-Wallis test.

  12. Association of Dehydration Severity With Weight

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

    Association of dehydration severity with weight will be assessed using the Kruskal-Wallis test.

  13. Association of Dehydration Severity With Sex

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

    Association of dehydration severity with sex will be assessed using the Fisher exact test.

  14. Association of Dehydration Severity With HIV Status

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

    Association of dehydration severity with HIV status will be assessed using the Fisher exact test.

  15. Association of Dehydration Severity With Malnutrition

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

    Association of dehydration severity with malnutrition will be assessed using the Fisher exact test.

  16. Association of Dehydration Severity With Growth Faltering

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

    Association of dehydration severity with growth faltering will be assessed using the Fisher exact test.

  17. Association of Dehydration Severity With Early Weaning

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

    Association of dehydration severity with early weaning will be assessed using the Fisher exact test.

  18. Association of Dehydration Severity With Non-Exclusive Breast Feeding

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

    Association of dehydration severity with early non-exclusive breast feeding will be assessed using the Fisher exact test.

  19. Number of Oocysts

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

  20. Proportion of Participants Shedding Oocysts

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

  21. Number of Participants by Parasite Presence Measured by Microscopy and the QuikChek™ Cryptosporidium Rapid Diagnostic Test (RDT)

    Time frame: Baseline, Days 3, 7, 14 and up to Day 21

  22. Number of Participants Screened for Each Site by Time of Year

    Time frame: Baseline

    Number of participants screened (i.e., present with diarrheal illness) for each site by time of year (i.e., per season).

  23. Number of Participants Enrolled for Each Site by Time of Year

    Time frame: Baseline

    Number of participants enrolled (i.e., Cryptosporidium positive) for each site by time of year (i.e., per season).

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Prospective Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants With Symptomatic Cryptosporidiosis in Endemic Countries

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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