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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-59
SponsorNovartis Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 1 trial group
Group A: Cryptosporidiosis Cohort

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline
2

Number and Percentage of Participants by Severity of Dehydration

Dehydration severity categories: * None * Some * Severe

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

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

Time frame
Baseline
2

Association of Diarrheal Chronicity With Height

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

Time frame
Baseline
3

Association of Diarrheal Chronicity With Weight

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

Time frame
Baseline
4

Association of Diarrheal Chronicity With Sex

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

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