Antibiotics for lower Respiratory Tract Infection in Children presenting in Primary Care - ARTIC PC

niversity of Southampton0 sites938 target enrollmentJuly 24, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Respiratory tract infections in children aged between 6 months and 12 years
Sponsor: niversity of Southampton
Enrollment: 938
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

July 24, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Southampton

•Children between 6 months and twelve years old presenting with an acute lower respiratory infection (LRTI), defined as an acute cough as the predominant symptom, judged by the GP to be infective in origin (any of: a systemic symptom (diarrhoea, fever, raised temperature), coryza, sputum production, wheezing, sore throat, earache), lasting \<21 days, and with other symptoms or signs localising to the lower tract (shortness of breath, sputum \- or more likely in this age group audible secretions suggesting sputum), Parent/guardian willing and able to be contacted for follow up and complete symptom diary for up to 28 days.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 938
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range 0
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range 0

•The cough is judged by the clinician to have a non\-infectious aetiology (e.g. hayfever or asthma) or almost certain viral aetiology (croup, where antibiotics are not commonly prescribed); immune\-compromised; and antibiotic use in previous 30 days. For the trial, suspected pneumonia based on clinical examination or being very severely ill as judged by the GP is an exclusion but such children can still enter the observational study. In addition only one child from each household will be recruited. Additionally children will be eligible for trial but eligible for cohort study if the child is immune\-compromised, has a history of antibiotic use in previous 30 days, has a clinical diagnosis of pneumonia, has had previous pneumonia, has focal rales, has a low oxygen saturation (\<92%), has severe tachypnoea (clinician judged), has Severe Asthma requiring long\-term maintenance oral steroids (as defined in the British Thoracic Society Step 5\).