Investigation of Fever Suspected as a Zoonosis Using Advanced Diagnostic Technologies- a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Clinical outcomes- relapse
研究概览
简要总结
Zoonosis including brucellosis and rickettsial infections are a major contributor to infectious morbidity in southern Israel. The Bedouins, a nomadic tribal population residing in the Negev area are notably exposed to domesticated animals including livestock, camels and companion animals, and their living conditions, especially with respect to poor sanitation in different Bedouin communities also expose them to rodents and disease vectors such as insects and arthropods. In this study, we aim to identify Bedouin patients arriving at the Soroka University Medical Center, a tertiary hospital un the Negev, with undifferentiated fever, suspected as a zoonosis.
We intend to use molecular methods to better diagnose the infectious agent using whole blood and serum samples, and when available other tissues or body fluid, and use next generation sequencing technology to deeply examine bacterial features such as virulence factors, and host pathogen interactions.
详细描述
This study aims to apply advanced technologies for the investigation of febrile illness in the Bedouin population, in order to improve laboratory diagnosis in terms of rapidity and sensitivity and to better our understanding of the pathophysiology of infectious diseases in the Bedouin population including various environmental exposures such as animal, water and waste and antibiotic exposure, as well as host-pathogen interactions associated with pathogen virulence, factors associated with chronicity and relapse, and response to treatment.
Study protocol:
Enrollment:
- After screening, patients will be approached and offered the opportunity to participate in the study.
- After signing of an informed consent patient will be interviewed and an enrollment questionnaire will be filled out.
- If the patient is enrolled in the ED, blood, saliva, and stool samples will be collected. In case the patient presented with a rash or a skin lesion, a swab from an open lesion will be obtained.
- If patient was enrolled after receiving antibiotics, we will also attempt to locate leftover blood samples that were drawn in the ED prior to receiving antibiotics.
Follow up:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Willing and able to provide informed consent (in case of children the legal guardian is willing to provide informed consent)
- •All patients of Bedouin origin arriving at the SUMC ED during the study period with:
- •fever >38.1 (either documented or reported), without an apparent infection source plus one of the following signs or symptoms
- •Arthralgia, arthritis
- •epididymo-orchitis
- •leukopenia, thrombocytopenia, elevated liver enzymes
- •other findings suggestive of zoonotic infection
- •Patients who were diagnosed with a zoonotic infection prior to or during hospital stay.
排除标准
- •- Patients with an established source of infection other than zoonosis (such as urinary tract infection, pneumonia, upper respiratory tract infection), or a non-infectious cause of fever (malignancy, rheumatic disease etc.).
- •Pregnant women
- •Children weighing less than 6.5 kg
结局指标
主要结局
Clinical outcomes- relapse
时间窗: patients will be under follow up for 6 months after enrollment
Assessment of infection relapse within 6 months
Clinical outcomes- symptom resolution
时间窗: patients will be under follow up for 6 months after enrollment, medical records will be reviewed for a year after enrollment
time to resolution of symptoms
Clinical outcomes- antibiotic use
时间窗: patients will be under follow up for 6 months after enrollment, medical records will be reviewed for a year after enrollment
recurrent use of antibiotics during the study period
Diagnosis of zoonotic infections
时间窗: patients will be under follow up for 6 months after enrollment
Molecular modes of diagnosis will be examined, in order to improve sensitivity and time to diagnosis
次要结局
未报告次要终点
研究者
Yael Yagel MD
Senior doctor, infectious diseases institute Soroka UMC
Soroka University Medical Center