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

niversity of Southampton (UK)0 sites438 target enrollmentAugust 21, 2015

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: ower Respiratory Tract Infection in children aged 6 months - 12 years
Sponsor: niversity of Southampton (UK)
Enrollment: 438
Status: Completed
Last Updated: 2 years ago

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34562391/ (added 27/09/2021) 2023 Results article in https://doi.org/10.3310/dgbv3199 (added 13/07/2023)

Registry

who.int

Start Date

August 21, 2015

End Date

April 17, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Southampton (UK)

•Children between 6 months and 12 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, lasting \<21 days, and with other symptoms or signs localising to the lower tract (shortness of breath, sputum, pain)
•Added 26/07/2016:
•Individuals who are allergic to penicillin, who cannot be randomised (e.g. with known immune deficiency, or where a complication such as pneumonia is suspected on clinical grounds), or are unwilling to be randomised, are still eligible for the observational study where the same outcomes will be measured.

•1\. The cough is judged by the clinician to have a non\-infectious aetiology (e.g., hayfever or non\-infective exacerbation of asthma) or almost certain viral aetiology (croup, where antibiotics are not commonly prescribed)
•2\. Immune\-compromised
•3\. Antibiotic use in previous 30 days
•4\. 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 which will allow for an assessment of trial participants’ external validity)
•5\. Only one child from each household will be recruited