NCT06379061已完成不适用
Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 4
- 主要终点
- Blood Specimen Collection
研究概览
简要总结
The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to establish the diagnostic performance of MeMed BV™ for differentiating bacterial from viral infection using method comparison and/or method concordance.
详细描述
The objective of this study is to collect blood specimens from pediatric (>90 days old) and adult patients (≥18 years old) presenting with signs and symptoms suggestive of acute bacterial or viral infection from hospital, Emergency Department, or Urgent Care Centers for comparative testing on the Access 2 and DxI 9000 Immunoassay Analyzers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 90 Days 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 90 days of age.
- •Clinical suspicion of acute bacterial or viral infection.
- •Temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported) or tactile fever, either of them noted at least once within the last 7 days.
- •Current disease duration ≤ 7 days.
排除标准
- •Previously enrolled
- •Insufficient sample volumes obtained
- •For the adult and pediatric populations, < 1.2 mL serum volume
- •Sample handling errors
- •Another unrelated episode of febrile infection within the past 2 weeks
- •Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
- •≥48 hours of oral antibiotic treatment
- •≥12 hours of intravenous\intramuscular antibiotic treatment
- •Human Immunodeficiency Viruses (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (self-declared or known from medical records)
- •A proven or suspected infection on presentation with Mycobacterial (e.g., Tuberculosis, MAC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen
- •Active inflammatory disease (e.g., Inflammatory Bowel Disease [IBD], Systemic Lupus Erythematosus [SLE], Juvenile Idiopathic Arthritis [JIA], Rheumatoid Arthritis [RA], Kawasaki, other vasculitis)
- •Major trauma and\or burns in the last 7 days.
- •Major surgery in the last 7 days
- •Congenital immune deficiency (CID)
- •Acquired immune deficiency\modulation state including
- •Active malignancy treated within last 6 months
- •Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:
- •i. Administration of P.O.\IV\IM high dose steroids >1mg/kg/day prednisone (or equivalent) at some point in the past 10 days or daily continuous use of steroids > 0.25 mg/kg/day in the past 7 days ii. Monoclonal antibodies, anti-TNF agents iii. Intravenous immunoglobulin (IVIG) iv. Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate v. G/GM-CSF Interferons c. Post solid organ/bone marrow transplant patients d. Asplenia, sickle cell disease
- •Indwelling central venous catheter
- •Cystic Fibrosis
- •Pregnancy - self-reported or medically known
- •Other severe illnesses that affect life expectancy and quality of life such as:
- •Severe psychomotor retardation
- •Congenital metabolic disorder
- •End stage renal disease, advanced heart failure (NYHA 3/4), advanced COPD (GOLD 3/4)
结局指标
主要结局
Blood Specimen Collection
时间窗: Less or equal to seven days
Collect blood specimens across multiple age ranges presenting symptoms of acute or viral infection
次要结局
未报告次要终点
研究者
研究点 (4)
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