Clinical Aspects, Severity, Management and Outcome of Febrile Illnesses in the Democratic Republic Congo (DRC).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,046
- 试验地点
- 2
- 主要终点
- Proportion of Survival With Symptom Resolution
研究概览
简要总结
This is a bi-centric prospective observational cohort study of adults and children presenting to the emergency room or outpatient department with community febrile illness (with or without signs of focalization) in 2 clinical sites (hospitals) in the DRC. The study will describe the epidemiology, clinical aspects, severity, management and outcome of febrile illnesses using data collected during routine diagnostic and therapeutic procedures.
Each patient will be followed for 21 days. The follow-up will include
- Daily visits for hospitalized patients,
- Telephone calls (or study center visit or home visit) on days 7, 14 and 21 for outpatients and discharged patients.
The study has been amended (EC UZA approval in June 2021) to perform a set of laboratory analyses in the partners institutions and at the ITM. We aim as a new primary objective at describing the profile of different biomarkers (C-reactive protein and white blood cell count with differentiation) in participants enrolled with febrile illness, and as secondary objectives to correlate them with outcome (assessed at day 21) and with several etiological diagnoses, especially malaria (as assessed by rapid diagnostic test and blood smear). The purpose is to investigate the potential diagnostic and prognostic value of these biomarkers which are increasingly available at the point-of-care.
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
- 2 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ongoing and objectified fever at presentation, or documented at home or other health center within 24 hours prior to presentation, defined by:
- •Axillary or tympanic temperature > 37.5°C OR
- •Oral or rectal temperature > 38°C
- •Possibility of contact between the patient (or designated relative) and the study team on days 7, 14 and 21
- •Informed consent signed by the patient (adults) or a legally acceptable representative (children or patients whose condition does not allow them to sign informed consent), with the consent of children as young as 12 years of age, whenever possible.
排除标准
- •Children less than two months old
- •Hospitalization > 48 h in the last 14 days (to exclude nosocomial fevers)
结局指标
主要结局
Proportion of Survival With Symptom Resolution
时间窗: Day 21
Proportion of survival with symptom resolution assessed at day 21, of febrile illnesses
CRP Values
时间窗: Day 0
CRP values at day 0 (inclusion)
White Blood Cell Count
时间窗: day 0
white blood cell count with differentiation at day 0 (inclusion)
次要结局
- Proportion of Survival With Symptom Resolution(Day 14)
- Proportion of Survival Without Symptom Resolution(Day 21)
- Proportion of Death(Day 21)
- Proportion of Participants With Initial Hospitalization(Day 21)
- Proportion of Participants With Secondary Hospitalization(Day 21)
- Length of Hospital Stay (Initial and/or Secondary Hospitalization)(Day 21)
- Number of Secondary Visits(Day 21)
- Patient Outcomes(Day 21)
- Severity of Illness(Day 21)
- Frequency of Malaria(Day 21)
- Parasitemia of Malaria(Day 21)