Respiratory infections are very common, especially during winter, and are often caused byviruses such as influenza, SARS-CoV-2 or respiratory syncytial virus (RSV).These illnesses are generally mild, but their symptoms do not always allow a cleardistinction to be made between a viral infection and a bacterial infection. In theabsence of a precise diagnosis, antibiotics may be prescribed when they are not necessaryin many cases.However, the excessive use of antibiotics contributes to the development of bacterialresistance, which is a major public health issue.The aim of this study is to better understand whether the use of a rapid test (calledTROD), which can quickly identify certain respiratory viruses, can help doctors reduceunnecessary antibiotic prescriptions for these infections. The test will be performedusing a swab gently inserted into the nose.
Bacterial resistance to antibiotics is a major global public health issue. In France,
this resistance is estimated to cause 158,000 infections annually (127,000 to 245,000),
including nearly 16,000 invasive infections, and 12,500 deaths per year. The additional
cost of antibiotics in France compared to the average for the most virtuous European
countries has been estimated at €441 million.
Reducing exposure to antibiotics by limiting their prescription to situations where they
are essential is one of the major levers for slowing down the emergence of resistance.
The vast majority of antibiotics are prescribed in outpatient settings (90% of
consumption, or 125 million units per year). In France, respiratory tract infections
account for 7 out of 10 prescriptions in primary care. However, the majority of
respiratory infections are viral in origin (influenza viruses, respiratory syncytial
virus (RSV), SARS-CoV-2, but also rhinoviruses, metapneumoviruses, etc.). The clinical
presentation of these infections is often non-specific. The lack of microbiological
aetiological diagnosis leads to the unnecessary prescription of antibiotics in many cases
of viral infections.
The rapid diagnostic tests (TROD) that have recently become available can test for RSV,
influenza viruses and SARS-CoV-2 simultaneously. They enable a diagnosis of viral
infection to be made during a consultation and should help to avoid the prescription of
antibiotics in these situations. In addition, these tests are simple and can be performed
routinely (in less than 15 minutes) without the need for specific equipment or technical
skills. Reducing inappropriate prescriptions of antibiotic treatments for viral
respiratory infections is therefore a public health priority that is likely to have a
significant impact on bacterial resistance, but also on the incidence of adverse effects
and the costs associated with these treatments.
At the request of the Haute Autorité de Santé (French National Authority for Health),
this study aims to estimate the impact of triplex TRODs (SARS-CoV-2/ influenza/RSV
detection) on antibiotic prescriptions in the general population in community settings
among patients with infectious syndrome, and to produce data (comparative to RT-PCR) to
better estimate the diagnostic performance, sensitivity and specificity of the test used
in the study.
The participation period for each participating doctor will be determined by random draw,
with the aim of ensuring that the start dates of participation are spread throughout the
study period, and with each doctor having a first control period without the use of tests
(n = 10 patients) followed by a second period with the use of tests (n = 10 patients).
Antibiotic prescriptions will be collected for each patient included during the two
periods.
Each investigator will begin the study (on the randomly selected date) by including 10
patients who meet the eligibility criteria during the period without testing (first
period), then the investigating physician will move on to the second period and use the
TROD for 10 other patients.
The main objective is to evaluate the impact of using triplex rapid diagnostic tests
(SARS-CoV-2/influenza/RSV) on antibiotic prescribing in the general population in
community settings during the autumn-winter season of 2025-2026.
The secondary objectives are to : 1. Compare the probability of prescription during the
initial consultation between the two study periods, 2. Compare the frequency of patient
re-consultations within 15 days of inclusion between the two study periods, 3. Compare
the proportions of patients with secondary hospitalisation within 15 days of inclusion
between the two study periods, 4. Compare total antibiotic consumption within 15 days of
inclusion between the two study periods, 5. Conduct a cost-consequence medical-economic
study, 6. Assess the impact of these tests according to patient characteristics (age,
medical history, initial symptoms, etc.) and prescribers (age, geographical area,
practice modalities.), 7. Assess the proportions of SARS-CoV-2/influenza/RSV during the
intervention period in patients presenting with all of the described symptoms of
respiratory infection, 8. Estimate the sensitivity and specificity of the TROD in
identifying different viruses using respiratory multiplex PCR, as well as the frequency
and nature of other respiratory viral infections, 9. Describe the epidemiology of other
respiratory viral infections, whether or not associated with SARS-CoV-2/influenza/RSV
infections.
Diagnostic Test: TROD
Patient with triplex TROD test. Doctors may or may not prescribe antibiotics with the
help of the results of triplex TROD tests.
Inclusion Criteria:
1. Age ≥ 1 year
2. Presenting with:
- Either fever (temperature > 38°C measured by patient or physician) within the
past 72 hours, and one of the following symptom combinations:
1. Rhinorrhea (white, yellow, or green discharge) and/or nasal obstruction,
and cough
2. Body aches, cough, and fatigue
3. Odynophagia and negative strepto-test
4. Cough
5. Otalgia
- Or suspicion of lower respiratory tract infection: signs of infection
(respiratory rate > 20/min, heart rate > 100/min, fatigue, Body aches, chills,
or fever), associated with pulmonary localization signs [cough, sputum, chest
pain, auscultatory abnormality (rhonchi, crackles, or wheezing)]
3. Affiliation with the national health insurance system
4. Informed consent obtained from the adult participant, or from the person(s) with
parental authority for a minor participant
Exclusion Criteria:
1. Requirement for hospitalization
2. Presence of a non-respiratory infection requiring concomitant antibiotic treatment.
3. Patients covered by State Medical Aid (AME)
Not Provided
Aurélien DINH, MD, PhD
+33 1 47 10 77 60
aurelien.dinh@aphp.fr
Jacques ROPERS, PharmD
+33 1 42 16 03 48
jacques.ropers@aphp.fr
Aurélien DINH, MD, PhD, Study Chair
Assistance Publique - Hôpitaux de Paris