Recruiting NCT07716410
A Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cryptosporidiosis. Basic parameters: 6 months — 59 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kenya, Malaysia, Zambia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants With Symptomatic Cryptosporidiosis in Endemic Countries
Overview
This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation.
Primary outcome measures
- Number and Percentage of Participants by Chronicity of Diarrhea [Time frame: Baseline]
- Number and Percentage of Participants by Severity of Dehydration [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 outcome measures (12)
- Association of Diarrheal Chronicity With Age [Time frame: Baseline]
- Association of Diarrheal Chronicity With Height [Time frame: Baseline]
- Association of Diarrheal Chronicity With Weight [Time frame: Baseline]
- Association of Diarrheal Chronicity With Sex [Time frame: Baseline]
- Association of Diarrheal Chronicity With HIV Status [Time frame: Baseline]
- Association of Diarrheal Chronicity With Malnutrition [Time frame: Baseline]
- Association of Diarrheal Chronicity With Growth Faltering [Time frame: Baseline]
- Association of Diarrheal Chronicity With Early Weaning [Time frame: Baseline]
- Association of Diarrheal Chronicity With Non-Exclusive Breast Feeding [Time frame: Baseline]
- Association of Dehydration Severity With Age [Time frame: 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 Weight [Time frame: Baseline, Days 3, 7, 14 and up to Day 21]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Malaysia · 2 centers
- Novartis Investigative Site — Kuantan
- Novartis Investigative Site — Kuala Lumpur
Kenya · 1 center
- Novartis Investigative Site — Kisumu
Zambia · 1 center
- Novartis Investigative Site — Lusaka
Identifiers
NCT: NCT07716410 · CMTHDLGY0031