ADEQUATE: Advanced Diagnostics for Enhanced Quality of Antibiotic prescription in respiratory Tract infections in Emergency rooms
SGUL AMR team is the Sponsor’s representative managing the Paediatric arm of the study. Dr Julia Bielicki (Steering Committee) and Dr Malte Kohns are the clinicians, and, with their team, they look after all the European centres participating in the study.
Innovative Medicines Initiative 2 Joint Undertaking
University Medical Center Utrecht
Type of Study
Prospective, multi-centre, individually randomised controlled open-label trial.
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 (autumn/winter months) in Europe, however timelines might be extended related to the COVID-19 situation.