NCT07716410招募中不适用
A Prospective Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants With Symptomatic Cryptosporidiosis in Endemic Countries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Number and Percentage of Participants by Chronicity of Diarrhea
研究概览
简要总结
This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Number and Percentage of Participants by Chronicity of Diarrhea
时间窗: 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
时间窗: Baseline, Days 3, 7, 14 and up to Day 21
Dehydration severity categories: * None * Some * Severe
Time to Resolution of Diarrhea and Dehydration
时间窗: Baseline, Days 3, 7, 14 and up to Day 21
次要结局
- Association of Diarrheal Chronicity With Age(Baseline)
- Association of Diarrheal Chronicity With Height(Baseline)
- Association of Diarrheal Chronicity With Weight(Baseline)
- Association of Diarrheal Chronicity With Sex(Baseline)
- Association of Diarrheal Chronicity With HIV Status(Baseline)
- Association of Diarrheal Chronicity With Malnutrition(Baseline)
- Association of Diarrheal Chronicity With Growth Faltering(Baseline)
- Association of Diarrheal Chronicity With Early Weaning(Baseline)
- Association of Diarrheal Chronicity With Non-Exclusive Breast Feeding(Baseline)
- Association of Dehydration Severity With Age(Baseline, Days 3, 7, 14 and up to Day 21)
- Association of Dehydration Severity With Height(Baseline, Days 3, 7, 14 and up to Day 21)
- Association of Dehydration Severity With Weight(Baseline, Days 3, 7, 14 and up to Day 21)
- Association of Dehydration Severity With Sex(Baseline, Days 3, 7, 14 and up to Day 21)
- Association of Dehydration Severity With HIV Status(Baseline, Days 3, 7, 14 and up to Day 21)
- Association of Dehydration Severity With Malnutrition(Baseline, Days 3, 7, 14 and up to Day 21)
- Association of Dehydration Severity With Growth Faltering(Baseline, Days 3, 7, 14 and up to Day 21)
- Association of Dehydration Severity With Early Weaning(Baseline, Days 3, 7, 14 and up to Day 21)
- Association of Dehydration Severity With Non-Exclusive Breast Feeding(Baseline, Days 3, 7, 14 and up to Day 21)
- 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 Enrolled for Each Site by Time of Year(Baseline)
研究者
研究点 (4)
Loading locations...
相似试验
尚未招募
不适用
Factors Affecting Recovery and Survival in Children with Severe Infection (Sepsis) who Require Breathing SupportCTRI/2026/03/106349Ms Kulal Prasali Sadashiva135
尚未招募
不适用
Understanding Spinal Muscular Atrophy in Children: Insights from a Public Hospital in Western IndiaCTRI/2025/07/090015Seth GS Medical College and KEM Hospital55
招募中
不适用
Predicting outcomes for children with status epilepticus using STEPS ScoreCTRI/2025/10/095805Not applicable126
尚未招募
不适用
Use of antifungal drugs in very sick children admitted to Intensive Care UnitCTRI/2025/03/08161380
尚未招募
不适用
Clinical Predictors of Severity in Pediatric Community-Acquired Pneumonia at Assiut University Children's HospitalCommunity-Acquired PneumoniaPediatric PneumoniaLower Respiratory Tract InfectionNCT07279675Assiut University67