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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 1 year

Rhinorrhea (white, yellow, or green discharge) and/or nasal obstruction, and cough

Body aches, cough, and fatigue

Odynophagia and negative strepto-test

Disqualifiers

Requirement for hospitalization

Presence of a non-respiratory infection requiring concomitant antibiotic treatment.

Patients covered by State Medical Aid (AME)

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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.

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: TRODExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Day 0 to Day 14

Secondary outcomes

1

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

Time frame
Day 0
2

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

Time frame
Day 0 to Day 14
3

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

Time frame
Day 0 to Day 14
4

Total antibiotic consumption on day 14 in both groups

Time frame
Day 0 to Day 14

Other outcomes

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