Impact of rapid diagnostic tests for capillary C-reactive protein (CRP) on antibiotic use in general medicine

Plain English summary of protocol

Background and study aims
According to the WHO, antibiotic resistance is on the increase worldwide. According to the European Surveillance of Antimicrobial Consumption Network (ESAC net), France is one of the leading prescribers of antibiotics in Europe, well above the European average, with a defined daily dose of 28.5, compared with the European average of 21.9. According to INSERM, one way of combating antibiotic resistance would be to use inexpensive, easy-to-use rapid tests. C-reactive protein (CRP) is a protein produced by the liver as a result of inflammation or infection in the body and rises rapidly in the blood. It is measured to give an idea of the likelihood of infection. CRP is often high in bacterial infections and low in viral infections. CRP is usually measured by taking a blood sample, but the result is not immediate. There is now an automated system for rapid CRP analysis (5 minutes), using a capillary sample taken from a drop of blood from the fingertip. This rapid assay could reduce the need for antibiotics and complementary tests, and help guide prescriptions. In practice capillary CRP is performed, for example, in the event of prolonged fever with no obvious clinical signs, to determine whether or not antibiotics should be prescribed. It can also be carried out when there is doubt as to whether a viral infection does not require an antibiotic prescription or a bacterial infection does. This study was designed by Clermont Ferrand’s General Practice Department to evaluate in real conditions this biological device. The study evaluates to what extent the CRP capillary assay reduces antibiotic prescriptions in primary care patients in medical practices with upper and lower respiratory infections. The secondary objectives aim to evaluate the medico-economic and psychological impacts of the use of the assay.

Who can participate?
Patients of all ages over 3 months old with respiratory infections in primary care

What does the study involve?
In this study, 84 GPs will be split into two groups through random assignment. The intervention group will receive CRP test machines for 12 months. The GPs in this group will use the CRP test on patients with respiratory infections. The control group will not receive the machines and will continue with their usual practice, without using the CRP tests. The study will include 4,200 patients in total, with 2,800 patients with lower respiratory infections (such as bronchitis or pneumonia) and 1,400 in the intervention group who will receive the CRP test. It will involve, 1,400 patients with upper respiratory infections (such as ear infections or sore throats), with 700 in the intervention group who will also receive the CRP test. The control group GPs will treat their patients without using the CRP test.

What are the possible benefits and risks of participating?
The possible benefits of participating are better diagnosis in primary care, less uncertainty, and combating collective and personal antibiotic resistance. There is no risk from providing the capillary sample.

Where is the study run from?
The sponsor is the Maison de santé des Batignolles, a healthcare establishment with a FINESS number (630012284) that promotes research. Clermont Auvergne University is the guarantor and supporter of the research project.

When is the study starting and how long is it expected to run for?
September 2023 to September 2026

Who is funding the study?
Clermont Auvergne University

Who is the main contact?
Prof Amélie Richard, amelie.richard@uca.fr

Contact information

Prof Amelie Richard
Public, Scientific, Principal Investigator

University of Clermont Auvergne
28 Place Henri Dunant
Clermont Ferrand
63 000
France

ORCID ID	0000-0001-9813-6632
Phone	+33 06 460 01 79 77
Email	amelie.richard@uca.fr

Study information

Eligibility

Locations

Countries of recruitment

• France

Study participating centre

Sponsor information

Funders

Funder type

University/education

Results and Publications

Study outputs

Additional files

46067_PIS.pdf

Editorial Notes

24/09/2024: National Agency for the Safety of Medicines and Health Products [Agence nationale de sécurité du médicament et des produits de santé (ANSM)] under the authority of the French Ministry of Health.