A multi-center, prospective, blinded validation study to assess the accuracy of a host-response based diagnostics for distinguishing between bacterIal and viral etiology in pediatric patients with lower respiratory tract infections and fever without source - OPPORTUNITY

niversitair Medisch Centrum Utrecht0 个研究点目标入组 250 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•Patients aged 1 to 60 months whose legal guardian agrees to sign an informed consent will be eligible for inclusion. ;The infectious disease group should also fulfill the following criteria:
•* Peak fever >=38°C (100.4°F) (AND)
•* Symptoms duration <= 6days (AND)
•* Clinical suspicion of LRTI (OR)
•* Fever without a clear source;The non-infectious disease control group will include:
•* Patients with clinical suspicion of a non-infectious disease

•- Another episode of an acute infection during the last 3 weeks
•- Congenital immune deficiency (CID)
•- A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
•- Active malignancy
•- Current treatment with immune-suppressive or immune-modulating therapies including without limitations:
•a) High dose steroids >1 mg/kg/day prednisone or equivalent
•b) Monoclonal antibody administration
•c) Intravenous immunoglobulin (IVIG)
•d) Cyclosporine
•e) G/GM-CSF
•f) Anti-TNF agents
•g) Interferon (of all kinds)
•-Other severe illnesses that affect life expectancy and quality of life such as:
•a) Moderate to severe psychomotor retardation
•b) Moderate to severe congenital metabolic disorder

发起方

niversitair Medisch Centrum Utrecht