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临床试验/NCT02656862
NCT02656862已完成不适用

Causes of Acute Undifferentiated Fever in Outpatients in the Democratic Republic of Congo

Institute of Tropical Medicine, Belgium1 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
301
试验地点
1
主要终点
Proportion of key pathogens among study participants with 'undifferentiated fever'

研究概览

简要总结

Fever is one of the main reasons for outpatient consultations in sub-saharan Africa. Following the introduction of malaria RDTs, clinicians face a high number of malaria-negative patients for whom they do not have a clear diagnosis. Through clinical history and examination, acute fever patients are categorized into: acute respiratory infections, urinary tract infections and other focal infections, diarrheal fevers and undifferentiated fevers. The latter being patients where no focal source of infections can be found during the consultation visit. In this proposal, the investigators focus on these acute undifferentiated fevers in an outpatient clinic.

These fevers have the challenge of few point-of-care tests (POCT) available for the clinicians to identify the etiology of fever and guide treatment in resource-limited countries. As a consequence, over-prescription of antibiotics has increased. In order to improve patient outcomes while supporting judicious use of antimicrobials, there is an urgent need to change the management of febrile patients in low-income countries. This can only be achieved by providing evidence-based clinical guidelines for the management of these acute febrile patients. To develop such guidelines, epidemiological data on etiologies of undifferentiated fever need to be generated. The investigators will evaluate pathogen infection (such as dengue, chikungunya and others) in 640 patients ≥ 2 years old with acute undifferentiated fever. To evaluate the existence of aspecific and subclinical infections and co-infections, the investigators will also test a subsample of 200 patients with ARI, UTI, diarrheal fever and malaria. The investigators expect to have as main results: proportions of each syndrome among fever patients, key pathogens associated with undifferentiated fever and their clinical presentation and demographic characteristics.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 2 years old
  • a history of acute fever (i.e. ≥ 2 days and ≤ 7 days)
  • an axillary temperature of ≥37.5°C
  • written informed consent obtained;

排除标准

  • main complaint for consultation is an injury, trauma or poisoning
  • hospitalization or delivery in the preceding 2 weeks
  • suspicion of meningitis/encephalitis

结局指标

主要结局

Proportion of key pathogens among study participants with 'undifferentiated fever'

时间窗: At consultation over a period of 6 months

The key pathogens will be identified through specific laboratory diagnostic tests on the blood/serum of included patients.

次要结局

未报告次要终点

研究者

发起方
Institute of Tropical Medicine, Belgium
申办方类型
Other
责任方
Sponsor

研究点 (1)

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