ADEQUATE Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms (ADEQUATE)

This is an interventional diagnostic trial for Respiratory Tract Infections Read More

Inclusion Criteria:

1. Adults (≥18 years old) presenting to the Emergency Room with an acute illness (present for 14 days or less) with cough, and with at least 1 other lower respiratory tract symptom or clinical sign at physical examination:

   • Sputum production,
   • Breathlessness,
   • Chest discomfort or chest pain,
   • Wheeze,
   • Crackles,
   • Self-reported dystermia or documented fever;

   • Documented hypoxemia (adjusting definition for chronic oxygen therapy users, method of measurement) and no alternative explanation (infection, such as sinusitis; other, such as asthma).

     2. Managing medical team considers:

     1. to treat patient with antibiotics and/or to hospitalize patient

        AND

     2. that the rapid syndromic diagnostic test result can be awaited up to a maximum of 4 hours before the decision to discharge the patient or to initiate antibiotic therapy.

Exclusion Criteria:

1. Development of ARTI more than 48 hours after hospital admission (hospital acquired);
2. Patients with cystic fibrosis;
3. Less than 14 days since the last episode of respiratory tract infection;
4. Pregnancy (confirmed by pregnancy test) and breastfeeding;
5. Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases or patients with short life expectancy;

6. Inability to obtain informed consent from a competent patient.

   Based on standard of care microbiological diagnosis and thoracic imaging (when indicated):

7. Radiologically confirmed acute lobar pneumonia;
8. Known or suspected Pneumocystis jirovecii pneumonia or active tuberculosis;
9. Alternative noninfectious diagnosis that explains clinical symptoms (pulmonary embolism, alveolar hemorrhage, acute heart failure, lung cancer).