ISRCTN11747901已完成未知
The use of unbiased next generation sequencing for pathogen detection in adults hospitalised with acute undifferentiated febrile illness and suspected infection: an observational pilot study (SePSI)
niversity Hospital Southampton NHS Foundation Trust (UK)0 个研究点目标入组 100 人开始时间: 2015年11月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Febrile participants:
- •1. Aged 18 years or over
- •2. Has the capacity to give informed, written consent and is able and willing to adhere to the study procedures
- •3. Is a patient in Southampton General Hospital Acute Medical Unit or Emergency Department OR is under the care or advice of the inpatient infectious diseases service
- •4. Can be recruited to the study
- •4.1. Within a 72-hour period of first triage by ED staff OR
- •4.2. Within a 72-hour period of arrival on AMU (if admitted directly to AMU)
- •4.3. Has an acute febrile illness with a documented fever =38°C, OR a history of fever in the preceding 72 hours
- •5. Has a duration of illness less than or equal to 21 days
- •6. Has an illness lacking localizable or clear organ-specific clinical features (as determined by the investigators), including but not limited to:
- •6.1. Pneumonia (as defined by new radiological consolidation)
- •6.2. Urinary tract infection
- •6.3. Cellulitis or other skin and soft tissue infections
- •6.4. Septic arthritis
- •6.5. Infected prosthetic material
- •6.6. Pyogenic spondylodiscitis
- •6.7. Meningitis
- •7. Has an illness lacking a clear non-infectious aetiology
- •Healthy volunteers:
- •1. Aged 18 years or over
- •2. Has the capacity to give informed, written consent and is able and willing to adhere to the study procedures
- •3. For women of childbearing potential, has a negative pregnancy test
- •4. Has been well with no symptoms of significant illness (including; fever, chills, sweats, myalgia, arthralgia, malaise, weight loss, cough, chest pain, rhinorrhoea, sore throat, abdominal pain, diarrhoea, dysuria, urinary frequency, haematuria, severe headache, collapse or seizure) in the past 14 days
- •5. Normally fit and well with no significant medical co-morbidity (including chronic cardiovascular, respiratory, renal, hepatic or neurological illness, diabetes mellitus, malignancy and others at discretion of the investigators)
- •6. Not immune compromised (as defined above)
排除标准
- •Febrile participants:
- •1. Patients not fulfilling inclusion criteria
- •2. A decision to palliate the patients symptoms taken by the treating clinicians
- •3. Declines collection of clinical specimens
- •4. Immune compromised as defined by;
- •4.1. HIV infection with a CD4 count of less than 200 cells/µl
- •4.2. Any primary immunodeficiency
- •4.3. Current or recent (within six months) chemotherapy or radiotherapy for malignancy
- •4.4. Solid organ transplant recipients on immunosuppressive therapy
- •4.5. Bone marrow transplant recipients currently receiving immunosuppressive treatment, or who received it within the last 12 months
- •4.6. Patients with current graft vs host disease
- •4.7. Patients currently receiving high dose systemic corticosteroids (equivalent to = 40 mg prednisolone per day for =3 week in an adult), and for at least three months after treatment has stopped
- •4.8. Patients currently or recently (within three months) on other types of immunosuppressive therapy.
- •5. The investigator feels that patient should not be enrolled (i.e. investigator discretion)
- •Involvement in other research trials is not necessarily an exclusion criterion. Concurrent, prior or subsequent enrolment in an observational study is not expected to be an exclusion criterion, except at the discretion of the PI.
- •Healthy volunteers:
- •1. Not meeting inclusion criteria
- •2. Receiving antibiotics or antiviral in the last 2 weeks
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