Causes of Acute Undifferentiated Fever and the Utility of Biomarkers in Differentiating Bacterial From Viral Infection Among Acute Febrile Patients in Northwest Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The differentiation of bacterial infections and viral infections among acute febrile patients with biomarkers
研究概览
简要总结
A cross-sectional study on acute undifferentiated fever and the utility of biomarkers in differentiating bacterial from viral infection among acute febrile patients in Gondar, northwest Ethiopia.
详细描述
General objective:
To assess the causes of acute undifferentiated febrile illness and evaluation of biomarkers for differentiation of bacterial and viral infections among outpatients at University of Gondar (UOG) Hospital, Northwest Ethiopia
Specific objectives
- To determine the number of malaria cases, bacterial infections (by blood culture and polymearase chain reaction (PCR) for Rickettsia and Borrelia), and arboviral infections (DENV, YFV, CHIKV) among all acute febrile patients
- To evaluate the diagnostic performance different assays (RDT, RT-(reverse transcriptase)PCR, ELISA) for the diagnosis of DENV
- To evaluate the qualitative detection of C-reactive protein (CRP) and Myxovirus resistance protein (MxA) (by FebriDx RDT) and quantitative CRP detection for differentiating bacterial and viral infections
Study design, population, materials and methods: a cross-sectional cohort study on febrile patients presenting with acute fever at the emergency ward of the UOG hospital from June to August 2019. Clinical and epidemiological data will be recorded in a pseudo-anonymized and collected using an electronic data collection tool (KoBoToolbox). Blood will be collected for RDT testing, blood culture, PCR and serum for ELISA and RT-PCR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with acute fever (an axillary temperature of ≥37.5°C; symptom duration ≤7 days)
- •≥ 15 years old
- •signed informed consent
排除标准
- •pregnant woman & children (<15 y)
- •febrile patient suspected of urinary tract infection or acute respiratory tract infection
- •Individuals who had taken antimicrobial and antimalarial drug in the last 2 weeks
- •Patients with acute injury or trauma or for which participation in the study implies an unacceptable health risk as determined by the physicians
结局指标
主要结局
The differentiation of bacterial infections and viral infections among acute febrile patients with biomarkers
时间窗: within 7 days after onset of fever
CRP (bacterial biomarker) and MxA (viral biomarker) will be evaluated for differentiating confirmed bacterial and viral infections.
次要结局
- The number of malaria cases, bacterial infections, viral infections and unknown etiologies among acute febrile patients in Gondar(within 7 days after onset of fever)
- The comparison of different assays for diagnosis of DENV(within 7 days after onset of fever)
- The comparison of the qualitative and qualitative detection of CRP for differentiating bacterial and viral infections(within 7 days after onset of fever)