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

July 15, 2026 updated by: Novartis Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cryptosporidiosis Cohort
Pediatric participants with diarrhea due to Cryptosporidium infection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline
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
Baseline, Days 3, 7, 14 and up to Day 21
Time to Resolution of Diarrhea and Dehydration
Time Frame: Baseline, Days 3, 7, 14 and up to Day 21
Baseline, Days 3, 7, 14 and up to Day 21

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Association of Diarrheal Chronicity With Age
Time Frame: Baseline
Association of diarrheal chronicity with age will be assessed using the Kruskal-Wallis test.
Baseline
Association of Diarrheal Chronicity With Height
Time Frame: Baseline
Association of diarrheal chronicity with height will be assessed using the Kruskal-Wallis test.
Baseline
Association of Diarrheal Chronicity With Weight
Time Frame: Baseline
Association of diarrheal chronicity with weight will be assessed using the Kruskal-Wallis test.
Baseline
Association of Diarrheal Chronicity With Sex
Time Frame: Baseline
Association of diarrheal chronicity with sex will be assessed using the Fisher exact test.
Baseline
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.
Baseline
Association of Diarrheal Chronicity With Malnutrition
Time Frame: Baseline
Association of diarrheal chronicity with malnutrition will be assessed using the Fisher exact test.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline, Days 3, 7, 14 and up to Day 21
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.
Baseline, Days 3, 7, 14 and up to Day 21
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.
Baseline, Days 3, 7, 14 and up to Day 21
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.
Baseline, Days 3, 7, 14 and up to Day 21
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.
Baseline, Days 3, 7, 14 and up to Day 21
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.
Baseline, Days 3, 7, 14 and up to Day 21
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.
Baseline, Days 3, 7, 14 and up to Day 21
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.
Baseline, Days 3, 7, 14 and up to Day 21
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.
Baseline, Days 3, 7, 14 and up to Day 21
Number of Oocysts
Time Frame: Baseline, Days 3, 7, 14 and up to Day 21
Baseline, Days 3, 7, 14 and up to Day 21
Proportion of Participants Shedding Oocysts
Time Frame: Baseline, Days 3, 7, 14 and up to Day 21
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)
Time Frame: Baseline, Days 3, 7, 14 and up to Day 21
Baseline, Days 3, 7, 14 and up to Day 21
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).
Baseline
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).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMTHDLGY0031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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