ADEQUATE Paediatric study

• Research type

  Research Study

• Full title

  Advanced Diagnostics for Enhanced QUality of Antibiotic prescription in respiratory Tract infections in Emergency rooms - ADEQUATE

• IRAS ID

  323120

• Contact name

  Julia Anna Bielicki

• Contact email

  jbielick@sgul.ac.uk

• Sponsor organisation

  Fondazione Penta Onlus

• Clinicaltrials.gov Identifier

  NCT04781530

• Duration of Study in the UK

  1 years, 2 months, 30 days

• Research summary

  Community-acquired acute respiratory tract infections (CA-ARTI) are among the most frequent infectious diseases worldwide. At the same time, uncomplicated acute respiratory infections (ARI) are the most frequent cause of inappropriate antibiotic use. Antibiotic resistance rates are related to antibiotic use in any setting, but opportunities to implement a more judicious antibiotic prescribing are probably most apparent in primary care and emergency departments (EDs).\n\nThe study population will include children of any age presenting to the ED of the selected participating sites with CAARTI with initial uncertainty about management regarding hospitalisation and/or antibiotic therapy.\n\nThe objective of the project is to assess the impact of rapid diagnostic testing (RDT), of patients with acute respiratory tract infections (ARTI) at the emergency department, on (1) hospital admission rates and (2) antibiotic prescriptions (days of treatment). In other words, the main objective is to assess the impact of RDT on clinical decision making related to:\n\n• Hospitalisation yes or no;\n• Start antibiotics yes or no.\n\nAt the same time, it must be determined whether the decisions guided by RDT results do not compromise patient safety.\n\nParticipation in the study involves collection of data that can be obtained from medical charts and follow up questionnaires and interviews. Participants will be randomly allocated to two groups. The control group will follow the routine patient flow as per standard of care. The intervention group will receive a nasopharyngeal swab at the ED. Based on the results of the RDT (BioFire FilmArray) antibiotics may be withheld when deemed unnecessary, or a different antibiotic class may be selected when certain bacterial pathogens are detected.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  22/WM/0279

• Date of REC Opinion

  23 Feb 2023

• REC opinion

  Further Information Favourable Opinion