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

N/ARecruitingNCT07716410

Novartis Pharmaceuticals30 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cryptosporidiosis

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

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.

Locations (4)

Novartis Investigative Site

Kisumu, Nyanza, Kenya

RECRUITING

Novartis Investigative Site

Kuantan, Pahang, Malaysia

RECRUITING

Novartis Investigative Site

Kuala Lumpur, Malaysia

RECRUITING

Outcomes

Primary Outcomes

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

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

Time to Resolution of Diarrhea and Dehydration

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

Secondary Outcomes

Association of Diarrheal Chronicity With Age

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

Time frame: Baseline

Association of Diarrheal Chronicity With Height

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

Time frame: Baseline

Association of Diarrheal Chronicity With Weight

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

Time frame: Baseline

Association of Diarrheal Chronicity With Sex

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

Time frame: Baseline

Association of Diarrheal Chronicity With HIV Status

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

Central Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Data from ClinicalTrials.gov

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Novartis Investigative Site

Lusaka, Zambia

RECRUITING

Time frame: Baseline

Association of Diarrheal Chronicity With Malnutrition

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

Time frame: Baseline

Association of Diarrheal Chronicity With Growth Faltering

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

Time frame: Baseline

Association of Diarrheal Chronicity With Early Weaning

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

Time frame: 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.

Time frame: Baseline

Association of Dehydration Severity With Age

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Proportion of Participants Shedding Oocysts

Time frame: 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

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).

Time frame: 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).

Time frame: Baseline