A Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants
2026년 7월 15일 업데이트: 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.
연구 개요
상태
모병
정황
연구 유형
관찰
등록 (추정된)
30
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Novartis Pharmaceuticals
- 전화번호: +41613241111
- 이메일: novartis.email@novartis.com
연구 연락처 백업
- 이름: Novartis Pharmaceuticals
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
Pediatric participants presenting with diarrhea and testing positive for Cryptosporidium by QuikChek™ and microscopy.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Cryptosporidiosis Cohort
Pediatric participants with diarrhea due to Cryptosporidium infection.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number and Percentage of Participants by Chronicity of Diarrhea
기간: Baseline
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Diarrhea chronicity categories:
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Baseline
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Number and Percentage of Participants by Severity of Dehydration
기간: Baseline, Days 3, 7, 14 and up to Day 21
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Dehydration severity categories:
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Baseline, Days 3, 7, 14 and up to Day 21
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Time to Resolution of Diarrhea and Dehydration
기간: Baseline, Days 3, 7, 14 and up to Day 21
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Baseline, Days 3, 7, 14 and up to Day 21
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Association of Diarrheal Chronicity With Age
기간: Baseline
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Association of diarrheal chronicity with age will be assessed using the Kruskal-Wallis test.
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Baseline
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Association of Diarrheal Chronicity With Height
기간: Baseline
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Association of diarrheal chronicity with height will be assessed using the Kruskal-Wallis test.
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Baseline
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Association of Diarrheal Chronicity With Weight
기간: Baseline
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Association of diarrheal chronicity with weight will be assessed using the Kruskal-Wallis test.
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Baseline
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Association of Diarrheal Chronicity With Sex
기간: Baseline
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Association of diarrheal chronicity with sex will be assessed using the Fisher exact test.
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Baseline
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Association of Diarrheal Chronicity With HIV Status
기간: Baseline
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Association of diarrheal chronicity with HIV status will be assessed using the Fisher exact test.
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Baseline
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Association of Diarrheal Chronicity With Malnutrition
기간: Baseline
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Association of diarrheal chronicity with malnutrition will be assessed using the Fisher exact test.
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Baseline
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Association of Diarrheal Chronicity With Growth Faltering
기간: Baseline
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Association of diarrheal chronicity with growth faltering will be assessed using the Fisher exact test.
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Baseline
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Association of Diarrheal Chronicity With Early Weaning
기간: Baseline
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Association of diarrheal chronicity with early weaning will be assessed using the Fisher exact test.
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Baseline
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Association of Diarrheal Chronicity With Non-Exclusive Breast Feeding
기간: Baseline
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Association of diarrheal chronicity with early non-exclusive breast feeding will be assessed using the Fisher exact test.
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Baseline
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Association of Dehydration Severity With Age
기간: Baseline, Days 3, 7, 14 and up to Day 21
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Association of dehydration severity with age will be assessed using the Kruskal-Wallis test.
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Baseline, Days 3, 7, 14 and up to Day 21
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Association of Dehydration Severity With Height
기간: Baseline, Days 3, 7, 14 and up to Day 21
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Association of dehydration severity with height will be assessed using the Kruskal-Wallis test.
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Baseline, Days 3, 7, 14 and up to Day 21
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Association of Dehydration Severity With Weight
기간: 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
기간: Baseline, Days 3, 7, 14 and up to Day 21
|
Association of dehydration severity with sex will be assessed using the Fisher exact test.
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Baseline, Days 3, 7, 14 and up to Day 21
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Association of Dehydration Severity With HIV Status
기간: 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.
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Baseline, Days 3, 7, 14 and up to Day 21
|
|
Association of Dehydration Severity With Malnutrition
기간: 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
기간: 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
기간: 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.
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Baseline, Days 3, 7, 14 and up to Day 21
|
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Association of Dehydration Severity With Non-Exclusive Breast Feeding
기간: Baseline, Days 3, 7, 14 and up to Day 21
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Association of dehydration severity with early non-exclusive breast feeding will be assessed using the Fisher exact test.
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Baseline, Days 3, 7, 14 and up to Day 21
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Number of Oocysts
기간: Baseline, Days 3, 7, 14 and up to Day 21
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Baseline, Days 3, 7, 14 and up to Day 21
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Proportion of Participants Shedding Oocysts
기간: Baseline, Days 3, 7, 14 and up to Day 21
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Baseline, Days 3, 7, 14 and up to Day 21
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Number of Participants by Parasite Presence Measured by Microscopy and the QuikChek™ Cryptosporidium Rapid Diagnostic Test (RDT)
기간: Baseline, Days 3, 7, 14 and up to Day 21
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Baseline, Days 3, 7, 14 and up to Day 21
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Number of Participants Screened for Each Site by Time of Year
기간: Baseline
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Number of participants screened (i.e., present with diarrheal illness) for each site by time of year (i.e., per season).
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Baseline
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Number of Participants Enrolled for Each Site by Time of Year
기간: Baseline
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Number of participants enrolled (i.e., Cryptosporidium positive) for each site by time of year (i.e., per season).
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Baseline
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Novartis Pharmaceuticals, Novartis Pharmaceuticals
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 1월 9일
기본 완료 (추정된)
2027년 5월 19일
연구 완료 (추정된)
2027년 5월 19일
연구 등록 날짜
최초 제출
2026년 6월 29일
QC 기준을 충족하는 최초 제출
2026년 7월 15일
처음 게시됨 (실제)
2026년 7월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 15일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .