Cryptosporidiosis
Conditions
Keywords
Cryptosporidium, Observational, Africa, Malaysia, Pediatric Diarrhea
Brief summary
This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants by Chronicity of Diarrhea | Baseline | Diarrhea chronicity categories: * Acute (\<7 days) * Prolonged (7-13 days) * Persistent (14-28 days) * Chronic (\>28 days) |
| Number and Percentage of Participants by Severity of Dehydration | Baseline, Days 3, 7, 14 and up to Day 21 | Dehydration severity categories: * None * Some * Severe |
| Time to Resolution of Diarrhea and Dehydration | Baseline, Days 3, 7, 14 and up to Day 21 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association of Diarrheal Chronicity With Age | Baseline | Association of diarrheal chronicity with age will be assessed using the Kruskal-Wallis test. |
| Association of Diarrheal Chronicity With Height | Baseline | Association of diarrheal chronicity with height will be assessed using the Kruskal-Wallis test. |
| Association of Diarrheal Chronicity With Weight | Baseline | Association of diarrheal chronicity with weight will be assessed using the Kruskal-Wallis test. |
| Association of Diarrheal Chronicity With Sex | Baseline | Association of diarrheal chronicity with sex will be assessed using the Fisher exact test. |
| Association of Diarrheal Chronicity With HIV Status | Baseline | Association of diarrheal chronicity with HIV status will be assessed using the Fisher exact test. |
| Association of Diarrheal Chronicity With Malnutrition | Baseline | Association of diarrheal chronicity with malnutrition will be assessed using the Fisher exact test. |
| Association of Diarrheal Chronicity With Growth Faltering | Baseline | Association of diarrheal chronicity with growth faltering will be assessed using the Fisher exact test. |
| Association of Diarrheal Chronicity With Early Weaning | Baseline | Association of diarrheal chronicity with early weaning will be assessed using the Fisher exact test. |
| Association of Diarrheal Chronicity With Non-Exclusive Breast Feeding | Baseline | Association of diarrheal chronicity with early non-exclusive breast feeding will be assessed using the Fisher exact test. |
| Association of Dehydration Severity With Age | Baseline, Days 3, 7, 14 and up to Day 21 | Association of dehydration severity with age will be assessed using the Kruskal-Wallis test. |
| Association of Dehydration Severity With Height | Baseline, Days 3, 7, 14 and up to Day 21 | Association of dehydration severity with height will be assessed using the Kruskal-Wallis test. |
| Association of Dehydration Severity With Weight | Baseline, Days 3, 7, 14 and up to Day 21 | Association of dehydration severity with weight will be assessed using the Kruskal-Wallis test. |
| Association of Dehydration Severity With Sex | Baseline, Days 3, 7, 14 and up to Day 21 | Association of dehydration severity with sex will be assessed using the Fisher exact test. |
| Association of Dehydration Severity With HIV Status | 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. |
| Association of Dehydration Severity With Malnutrition | Baseline, Days 3, 7, 14 and up to Day 21 | Association of dehydration severity with malnutrition will be assessed using the Fisher exact test. |
| Association of Dehydration Severity With Growth Faltering | 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. |
| Association of Dehydration Severity With Early Weaning | 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. |
| Association of Dehydration Severity With Non-Exclusive Breast Feeding | 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. |
| Number of Oocysts | Baseline, Days 3, 7, 14 and up to Day 21 | — |
| Proportion of Participants Shedding Oocysts | 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) | Baseline, Days 3, 7, 14 and up to Day 21 | — |
| Number of Participants Screened for Each Site by Time of Year | Baseline | Number of participants screened (i.e., present with diarrheal illness) for each site by time of year (i.e., per season). |
| Number of Participants Enrolled for Each Site by Time of Year | Baseline | Number of participants enrolled (i.e., Cryptosporidium positive) for each site by time of year (i.e., per season). |
Countries
Kenya, Malaysia, Zambia
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed