Validating Clinical Decision Aids for the Assessment and Management of Febrile Infants Presenting to Emergency Care in the UK and Ireland.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,076
- 试验地点
- 1
- 主要终点
- Urinary Tract Infection
研究概览
简要总结
Febrile infants under 3 months of age represent a high risk group for invasive bacterial infection (IBI) and UTI with approximately 10-20% having bacteremia, meningitis or urinary tract infection. The assessment of febrile infants is challenging, and current National Institute for Health and Care Excellence (NICE) guidance advocates a cautious approach with the majority of infants requiring a septic screen, parenteral broad-spectrum antibiotics, and admission to hospital. Internationally there is significant variation in the approach to febrile infants with European and USA guidance advocating a tailored approach based on clinical features and biomarker testing. None of the available clinical decision aids (CDA) have been validated in a UK and Irish cohort. The main objectives of the FIDO study are to report performance accuracy of CDA in a UK (United Kingdom) and Irish population, and describe the aetiology of SBI in young infants.
The FIDO study is a prospective observational cohort study of infants under 90 days of age with a measured fever greater than 38 Centrigrade within 24 hours of presentation. The study will run for approximately 12 months and recruit a minimum of 1000 participants.Symptoms, clinical features and laboratory results will be recorded on an electronic case report form (CRF) by the attending clinician.
详细描述
Background
Infants below three months of age are at high risk of invasive bacterial infections (IBI) and urinary tract infections (UTI). Recent studies have reported the combined rate of IBI and UTI in the range of 10 - 20% , with IBI (bacteremia and meningitis) account for to up to 3% of the total. Unlike older children infants regularly appear well or have non-specific features despite having an IBI or UTI, with history and physical examination alone not sufficient to detect all cases. Furthermore, the clinical differentiation between fever caused by bacteria and viruses is most challenging in the less than three month age group. The majority of children still have self-limiting illness in this age group making risk assessment challenging for clinicians.
The ideal approach to the assessment and management of febrile infants is not clear, as exemplified by the contrasting approaches advocated by the National Institute for Health and Care Excellence (NICE). The NICE guideline 51 (NG51) "Sepsis: recognition, diagnosis and early management" advises that all febrile infants (under 3 months of age) receive parenteral antibiotics immediately whereas NICE guideline 143 (NG143) "Fever in under 5s: assessment and initial management" suggests a tailored approach based on clinical assessment and laboratory testing. The recently proposed British Society for Antimicrobial Chemotherapy (BSAC) guidance also supports a tailored approach similar to the NICE guideline NG143. The primary aim of this study is to prospectively validate these CDA.
Objectives Primary Objectives
- Report the aetiology of IBI in febrile infants under three months in the UK and Ireland.
- Describe the clinical and laboratory predictors of IBI in febrile infants under three months of age.
- Report the performance of tailored CDAs to correctly identify a cohort suitable for management without parenteral antibiotics.
- Report the performance of tailored CDAs to correctly identify a cohort suitable for management without lumbar puncture.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants 90 days of age and under with a fever of greater than 38 Centigrade during their time in the Emergency Department (ED) or Assessment Unit (AU) or with a history of fever of greater than 38 Centigrade recorded by anyone via any thermometer type within the last 24 hours.
排除标准
- 未提供
结局指标
主要结局
Urinary Tract Infection
时间窗: 7 days of attendance
Urinary Tract Infection (UTI) will be confirmed by \>100,000 CFU/ml of a single organism from a single clean urine (clean catch, suprapubic aspiration, urethral catheter specimen) or \>100,000 CFU/ml of the same single organism from two non-clean urine samples (pads, bags, cotton wool) and pyuria (\>5 white blood cells per high-powered field) on laboratory microscopy.
Bacteriaemia
时间窗: 7 days of attendance
Bacteremia will be confirmed by bacterial culture or molecular testing of blood using quantitative polymerase chain reaction. The reference standard test will be performed by staff blinded to the clinical data and suspected diagnosis.
Bacterial Meningitis
时间窗: 7 days of attendance
Meningitis will be confirmed by culture or molecular testing of cerebrospinal fluid (CSF).The reference standard test will be performed by staff blinded to the clinical data and suspected diagnosis.
次要结局
未报告次要终点
研究者
Thomas Waterfield
Clinical Lecturer
Queen's University, Belfast