Community-acquired sepsis-like syndrome and paediatric acute respiratory tract infection in childhood study

Completed

• Conditions: Sepsis-like syndrome (SLS) and acute respiratory infections (ARI) in children; Infections and Infestations

• Registration Number: ISRCTN66872125
• Lead Sponsor: Fondazione PENTA Onlus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-30
• Last Update Posted: 24 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

CONTROLS:
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

Exclusion Criteria

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

Controls:
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

Study & Design

• Study Type: Observational
• Study Design: Not specified