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临床试验/NCT06122259
NCT06122259招募中不适用

Multidisciplinary Surveillance and Investigation of Febrile Illness in Guinea

Centre National de Formation et de Recherche en Sante Rurale1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2023年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,500
试验地点
1
主要终点
Pattern of symptoms and laboratory results at presentation and during follow-up

研究概览

简要总结

To date, the underlying causes of community-acquired fever, particularly non-malarial fever, are insufficiently documented in Guinea. Moreover, diagnostic capacity is limited, leading to inadequate prescription of antibiotics and antimalarials, as well as substantial delay in outbreak recognition. Thus, the investigators undertook a prospective observational multi-centric cohort study of febrile patients presenting at the emergency and outpatient department of selected health centers, districts and regional hospitals in four ecologically distinct sentinel health districts in Guinea.

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

入选标准

  • Age ≥2 months old
  • Documented fever (axillary temperature >37.5°C) at presentation or fever reported within the prior 24 hours
  • Availability for follow-up for 21 days
  • Willingness and ability of the patient or culturally acceptable representative to give informed consent for participation in the study

排除标准

  • History of hospitalization (for > 48 hours within the last 14 days) at any health facility

结局指标

主要结局

Pattern of symptoms and laboratory results at presentation and during follow-up

时间窗: Day 0 and day 21

Proportion will be estimated

Immediate or secondary hospital admissions and of secondary/unscheduled visits

时间窗: Day 0 and day 21

Proportion will be estimated

Pattern and duration of antibiotic use (and other treatments)

时间窗: Day 0

Proportion and mean or median will be estimated

Participants alive (with or without symptoms) or dead at day 21.

时间窗: Day 21

Survival or mortality rate will be estimated

Syndromic and/or etiologic diagnoses as established at day 21

时间窗: Day 0

Proportion will be estimated

次要结局

  • Cases fulfilling any of the case definitions of the 20 epidemic-prone infections under surveillance as compared to the final diagnosis and proportion of them timely reported to health authorities(Day 0)
  • Association of seasonal, geographical, demographic, clinical and first-line laboratory variables (malaria RDT and smear, biochemistry) with presenting syndromes/main etiologies(Day 0)
  • Confirmed arboviral pathogens and identification of epidemiological/clinical/laboratory predictors(Day 0)
  • White blood cells and C-reactive protein levels at baseline and association with syndromic/etiologic diagnoses and with patient outcome at day 21(Day 0)

研究者

发起方
Centre National de Formation et de Recherche en Sante Rurale
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Karifa Kourouma

Principal Investigator

Centre National de Formation et de Recherche en Sante Rurale

研究点 (1)

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Febrile Illness in Guinea | 临床试验