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Respiratory InfectionsTROD-VILLENCT07243249

Study Evaluating the Impact of Using Triplex Rapid Diagnostic Tests (SARS-CoV-2/Influenza/RSV) on Antibiotic Prescribing

A study testing TROD in people with Respiratory Infections and Antibiotic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Respiratory infections are very common, especially during winter, and are often caused by viruses such as influenza, SARS-CoV-2 or respiratory syncytial virus (RSV). These illnesses are generally mild, but their symptoms do not always allow a clear distinction to be made between a viral infection and a bacterial… Read more about this study

Who is it for?
Ages 1 year and older
Conditions the study is for
Respiratory Infections, Antibiotic
What is being tested?
TROD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
1 siteFrance
Study dates
7 Jan 2026to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥ 1 year
  • Presenting with:
  • Either fever (temperature > 38°C measured by patient or physician) within the past 72 hours, and one of the following symptom combinations:
  • Rhinorrhea (white, yellow, or green discharge) and/or nasal obstruction, and cough
  • Body aches, cough, and fatigue
  • Odynophagia and negative strepto-test
Show all 11Show fewer
  • Cough
  • 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)]
  • Affiliation with the national health insurance system
  • Informed consent obtained from the adult participant, or from the person(s) with parental authority for a minor participant

Who cannot join

  • Requirement for hospitalization
  • Presence of a non-respiratory infection requiring concomitant antibiotic treatment.
  • Patients covered by State Medical Aid (AME)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aurélien DINH, MD, PhD contact

+33 1 47 10 77 60

aurelien.dinh@aphp.fr

Jacques ROPERS, PharmD contact

+33 1 42 16 03 48

jacques.ropers@aphp.fr

France1 site, 1 recruiting
  • Assistance Publique - Hôpitaux de Paris

    Garches

    Aurélien DINH, MD, PhD, +33 1 47 10 77 60, aurelien.dinh@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: Study Evaluating the Impact of Using Triplex Rapid Diagnostic Tests (SARS-CoV-2/Influenza/RSV) on Antibiotic Prescribing in the General Population in Community Settings

Respiratory infections are very common, especially during winter, and are often caused by viruses such as influenza, SARS-CoV-2 or respiratory syncytial virus (RSV).

These illnesses are generally mild, but their symptoms do not always allow a clear distinction to be made between a viral infection and a bacterial infection. In the absence of a precise diagnosis, antibiotics may be prescribed when they are not necessary in many cases.

Read more

However, the excessive use of antibiotics contributes to the development of bacterial resistance, which is a major public health issue.

The aim of this study is to better understand whether the use of a rapid test (called TROD), which can quickly identify certain respiratory viruses, can help doctors reduce unnecessary antibiotic prescriptions for these infections. The test will be performed using a swab gently inserted into the nose.

Read the detailed description

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.

Being tested
TROD
Keywords
Respiratory infections, Antibiotic, Rapid diagnostic tests
Medical subject headings
Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRODDiagnostic test

    Patient with triplex TROD test. Doctors may or may not prescribe antibiotics with the help of the results of triplex TROD tests.

Study groups in NCT07243249
Study groupRoleWhat they receive
ControlNo interventionPatients without triplex TROD tests. Doctors may or may not prescribe antibiotics probabilistically as usual.
TRODExperimentalPatient with triplex TROD test. Doctors may or may not prescribe antibiotics with the help of the results of triplex TROD tests.
Receives: Diagnostic Test: TROD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Variation in the probability of antibiotic prescription between adjacent periods differing in the use of tests TROD

    Variation in antibiotic prescription rate between 1st periods during which doctors prescribe antibiotics probabilistically without rapid diagnostic tests (TROD) as usual, followed by 2nd periods during which antibiotic prescription is guided by the results of triple TROD (SARS-CoV-2/influenza/RSV). The primary endpoint will take into account all antibiotic prescriptions received by patients within 15 days of inclusion, whether they were prescribed at the end of the consultation that led to inclusion or during follow-up consultations.

    Measured: Day 0 to Day 14

Secondary outcomes (9)
  1. Percentage of patients receiving an antibiotic prescription at the initial consultation in both groups

    Measured: Day 0

  2. Percentage of patients requiring a new medical consultation between inclusion and day 14 in both groups

    Measured: Day 0 to Day 14

  3. Percentage of patients requiring secondary hospitalisation between inclusion and day 14 in both groups

    Measured: Day 0 to Day 14

  4. Total antibiotic consumption on day 14 in both groups

    Measured: Day 0 to Day 14

  5. Total cost of patient care

    Cost-consequence medical-economic study

    Measured: Day 0 to Day 14

  6. Previous criteria 2-4 according to patient characteristics and prescribers

    Measured: Day 0 to Day 14

  7. Percentage of patients with positive TROD results for the viruses studied during the intervention period (PCR and TROD)

    Measured: Day 0 to Day 14

  8. Estimation of the sensitivities and specificities of the TROD with regard to different viruses

    TROD compared to the identification of different viruses using respiratory multiplex PCR in approximately 750 patients

    Measured: Day 0

  9. Frequency of other respiratory viral infections associated or not associated with SARS-CoV-2/influenza/Respiratory syncytial virus infections

    Epidemiology of other respiratory viral infections associated or not associated with SARS-CoV-2/influenza/RSV among Influenza A, Influenza B, Respiratory syncytial virus, SARS-CoV-2, Adenovirus B/E, Adenovirus C, Metapneumovirus, Enterovirus/rhinovirus, Coronavirus OC43, Coronavirus HKU1, Coronavirus 229E, Coronavirus NL63, Human parainfluenza virus 1 to 4.

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2025
  2. Study start7 Jan 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07243249
Sponsor's protocol ID
APHP250413
Other IDs
2025-A02154-45
Acronym
TROD-VILLE
Status last verified
Jan 2026
First submitted
17 Nov 2025
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing TROD in people with Respiratory Infections and Antibiotic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aurélien DINH, MD, PhD (+33 1 47 10 77 60, aurelien.dinh@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation in the probability of antibiotic prescription between adjacent periods differing in the use of tests TROD (time frame: Day 0 to Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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