ISRCTN66872125已完成不适用
Multi-centre EuRopean study of MAjor Infectious Disease Syndromes (MERMAIDS): community-acquired sepsis-like syndrome and paediatric acute respiratory tract infection in childhood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
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
- •The study will recruit into three groups (SLS, ARI and controls), each with different inclusion criteria.
- •SLS Group Cases:
- •1. Age <6 months old on the day of admission (day 0) into the study
- •2. Onset of symptoms within 7 days
- •3. The attending physician has decided that the infant requires hospitalisation
- •4. Temperature =38°C or <36°C measured by any method
- •5. Informed consent collected on admission or within 48 hours available from guardian/carer
- •AND at least TWO of the below (with at least ONE of either 1 or 2):
- •1. Signs of cardiovascular dysfunction: age-related tachycardia or bradychardia or hypotension or need for =40 ml/kg fluid resuscitation in first hour after presentation to hospital on day of recruitment
- •2. Signs of respiratory dysfunction: age-related tachypnoea or brady/apnoea or decreased oxygen saturation (<92% in room air)
- •3. Skin signs: mottled skin appearance or non-blanching rash or central CRT >2 seconds
- •4. Neurological signs: irritability, hypotonia, lethargy or an AVPU score V or below
- •ARI Group Cases:
- •1. Age <6 years old on the day of admission (day 0) into the study
- •2. Clinical suspicion of a new episode of acute respiratory tract illness within the last 7 days
- •3. The attending physician has decided that the child requires hospitalisation
- •4. Primary reason for hospital admission is clinical suspicion of a new episode of ARI
- •5. Temperature =38°C measured by any method
- •6. Informed consent collected on admission or within 48 hours available from guardian/carer
- •AND at least TWO of the below (with at least ONE of 1 or 2):
- •1. Signs of lower respiratory tract infection: cough, abnormal sounds on chest auscultation (crackles, reduced breath sounds, bronchial breathing, wheezing), dyspnoea (chest indrawing, nasal flaring, grunting)
- •2. Signs of upper respiratory tract infection: coryza, nasal congestion, sore throat, pharyngitis, myringitis, acute otitis media
- •3. Signs of respiratory dysfunction: age-related tachypnoea or brady/apnoea or decreased oxygen saturation (<92% in room air)
- •4. Signs of reduced general state: poor feeding, vomiting, lethargy/drowsiness
- •1. Age < 6 years old on the day of enrolment into the study
- •2. Afebrile on the day of enrolment
- •3. No evidence of severe infection as judged by attending physician
- •4. Informed consent available from guardian/carer
- •Controls aged < 6 months old will be shared between both groups. Controls should be matched to cases stratified by five age groups (0-3 months, 4-6 months, 7-11 months, 12 months-2 years and 3-5 years) and season (three-monthly intervals starting with January-March). They may be selected from the following patient groups:
- •1. Attending for an elective or semi-elective procedure requiring general anaesthesia or moderate-deep sedation
- •(including e.g. surgery, radiological examinations etc)
- •2. Well and otherwise healthy children attending outpatient clinic for a non-emergency clinical assessment for which a blood test is indicated as part of routine clinical care
排除标准
- •The study will recruit into three groups (SLS, ARI and case-controls), each with different exclusion criteria.
- •SLS Group Cases:
- •1. In-patient care for 24 hours or more for any condition within the previous 30 days, except for routine postnatal care
- •2. Aetiology other than infection (such as trauma, autoimmune disorder, malignancy) is suspected to be the primary cause of the current illness episode
- •3. Any signs and symptoms suggesting a clear primary focus of infection, such as pneumonia, urinary/kidney infection, open wounds, indwelling catheters, re-activation of previously diagnosed infectious or inflammatory condition
- •4. Dehydration due to previous illness episode such as diarrhoea and vomiting
- •5. Immunocompromised infant (stem cell transplant, solid organ transplant, HIV, AIDS, immunosuppressive therapy, inherited or congenital immunodeficiency, haemodialysis)
- •6. Presence of complex chronic comorbidities
- •7. Body weight <3kg on day of assessment and/or corrected gestational age <37 weeks
- •ARI Group Cases:
- •1. In-patient care for 24 hours or more for any condition within the previous 30 days, except for routine postnatal care
- •2. Aetiology other than infection (such as trauma, autoimmune disorder, malignancy) is suspected to be the primary cause of the current illness episode
- •3. Any signs and symptoms suggesting a clear primary focus of infection, such as urinary/kidney infection, open
- •wounds, indwelling catheters, re-activation of previously diagnosed infectious or inflammatory condition
- •4. Dehydration due to previous illness episode such as diarrhoea and vomiting
- •5. Immunocompromised infant (stem cell transplant, solid organ transplant, HIV, AIDS, immunosuppressive therapy, inherited or congenital immunodeficiency, haemodialysis)
- •6. Presence of complex chronic comorbidities
- •7. Body weight <3 kg on day of assessment and/or corrected gestational age <37 weeks
- •1. In-patient care for 24 hours or more for any condition within the previous 30 days except for routine postnatal care or current planned hospitalisation/procedure
- •2. Temperature =38.5°C or <36°C
- •3. Immunocompromised infant (stem cell transplant, solid organ transplant, HIV, AIDS, immunosuppressive therapy, inherited or congenital immunodeficiency, haemodialysis)
- •4. Presence of complex chronic comorbidities
- •5. Body weight <3kg on day of assessment and/or corrected gestational age <37 weeks
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