Rapid nose-swab test for COVID-19, influenza, and RSV to reduce unnecessary antibiotic use

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

This will test whether a quick nose-swab that detects COVID-19, flu, and RSV helps doctors avoid prescribing antibiotics for people aged 1 and older with recent respiratory symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2000 (estimated)
• Ages: 1 Year and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Garches)
• Trial ID: NCT07243249 on ClinicalTrials.gov

What this trial studies

This interventional study uses a point-of-care triplex rapid diagnostic test (TROD) performed via a nasal swab to detect SARS-CoV-2, influenza viruses, and RSV during outpatient consultations. Eligible participants are people age 1 and older presenting with recent fever or respiratory symptoms or suspected lower respiratory tract infection who are affiliated with the French national health insurance system. Test results are provided during the visit to inform the clinician’s decision about whether to prescribe antibiotics, with prescribing behavior and short-term clinical outcomes tracked afterwards. The aim is to see if rapid viral identification leads to fewer unnecessary antibiotic prescriptions and reduced antibiotic exposure in the community.

Who should consider this trial

Good fit: Ideal candidates are people aged 1 or older who present to outpatient care with recent fever or respiratory symptoms (including cough, sore throat, nasal symptoms, ear pain, or signs of lower respiratory infection) and can provide consent.

Not a fit: Patients requiring hospitalization, those with a clear non-respiratory infection, or individuals with symptoms outside the study’s inclusion window are unlikely to benefit from this rapid outpatient testing approach.

Why it matters

Potential benefit: If successful, using the rapid triplex test could lower unnecessary antibiotic prescriptions for common respiratory illnesses, reducing side effects, costs, and the development of antibiotic resistance.

How similar studies have performed: Previous outpatient studies of point-of-care viral testing have shown reductions in antibiotic prescribing in some settings, though results are mixed and combined SARS-CoV-2/influenza/RSV triplex testing is a relatively new approach.

Eligibility criteria

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)

Where this trial is running

Garches

• Assistance Publique - Hôpitaux de Paris — Garches, France (Recruiting)

Study contacts

• Study coordinator: Aurélien DINH, MD, PhD

Conditions Respiratory Infections; Antibiotic; Respiratory infections; Rapid diagnostic tests