RESEARCH.

ADEQUATE

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.

Funder

Innovative Medicines Initiative 2 Joint Undertaking

Sponsor

University Medical Center Utrecht

Type of Study

Prospective, multi-centre, individually randomised controlled open-label trial.

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.

Project Duration

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.

Partners

PENTA Logo
European Union Horizon 2020 Funding for Research and Innovation
European Federation of Pharmaceutical Industries and Associations logo
BioMérieux logo
Janssen Pharmaceuticals logo
Accelerate Diagnostics Logo
Abbott Laboratories logo
Bio Rad Logo
Becton Dickinson Logo
Wellcome Trust Limited
University of Antwerp Logo
University of Oxford Logo
Universita di Verona Logo
University of Edinburgh Logo
University Medical Center Groningen Logo
Rambam Health Care Campus Logo
Universidad de la Rioja Logo
Boston University Logo
Bioaster Microbiology Technology Institute Logo
Find Logo
NICE National Institute for Health and Care Excellence Logo
Gesundheit Österreich Logo
ESCMID European Society of Clinical Microbiology and Infectious Diseases Logo
ERS European Respiratory Society Logo
Berry Consultants Logo
IBBL Integrated Biobank of Luxembourg Logo
ZonMw Logo