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

NCT07243249 | Recruiting

• 2 other identifiers: APHP2504132025-A02154-45
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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 infection. In the absence of a precise diagnosis, antibiotics may be prescribed when they are not necessary in many cases. 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.

Conditions

Respiratory Infections; Antibiotic

Keywords

Respiratory infections; Antibiotic; Rapid diagnostic tests

Outcome Measures

Primary Outcomes (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.

  Day 0 to Day 14

Secondary Outcomes (9)

• Percentage of patients receiving an antibiotic prescription at the initial consultation in both groups

  Day 0

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

  Day 0 to Day 14

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

  Day 0 to Day 14

• Total antibiotic consumption on day 14 in both groups

  Day 0 to Day 14

• Total cost of patient care

  Day 0 to Day 14

Study Arms (2)

Control

NO INTERVENTION

Patients without triplex TROD tests. Doctors may or may not prescribe antibiotics probabilistically as usual.

TROD

EXPERIMENTAL

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

Diagnostic Test: TROD

Interventions

TROD DIAGNOSTIC_TEST

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

TROD

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique - Hôpitaux de Paris

Garches, France

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Aurélien DINH, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: January 7, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

FR (1)