ADEQUATE study (paediatric)
Research type
Research Study
Full title
ADEQUATE Advanced Diagnostics for Enhanced QUality of Antibiotic prescription in respiratory Tract infections in Emergency rooms
IRAS ID
296974
Contact name
Julia Bielicki
Contact email
Sponsor organisation
University Medical Center Utrecht
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 31 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).
The study population will include children of any age presenting to the ED of the selected participating sites with CA-ARTI with initial uncertainty about management regarding hospitalisation and/or antibiotic therapy.
The 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) antimicrobial prescriptions (days of treatment) and (3) the non-inferiority in terms of clinical outcome (RDT vs usual methods of diagnostic testing). In other words, the main objective is to assess the impact of RDT on clinical decision making related to:
• Hospitalisation yes or no;
• Start antibiotics yes or no.At the same time, it must be determined whether the decisions guided by RDT results do not compromise patient safety.
Participation 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 who do not produce sputum 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.
The study will encompass at least 2 influenza seasons.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
21/NE/0183
Date of REC Opinion
29 Nov 2021
REC opinion
Further Information Favourable Opinion