This study is a randomized controlled trial where participants are randomly assigned in a 1:1 ratio to either a rapid test group or a control group. Standard care is provided in the control group. Follow-up is conducted until discharge from the hospital, followed by telephone check-ins and completion of questionnaires by the participants themselves or their proxies until 30 days after randomization. Children of any age presenting at selected participating sites with acute respiratory tract infections, where initial treatment decisions are uncertain, are eligible to participate. The study aims to enrol 520 participants and involves Paediatric Emergency Rooms across Europe.
Who can participate
Age range17 Years
SexALL
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Inclusion criteria
✓. Children of any age presenting to the Emergency Room with an acute illness (present for 14 days or less) with Temperature ≥38.0°C measured at presentation or reported within the previous 24 hours
✓. At time of screening:
Exclusion criteria
✕. Development of ARTI more than 48 hours after hospital admission (hospital acquired);
✕. Patients with a severe underlying medical condition dictating management decisions including hospitalisation and/or antibiotic treatment (e.g cystic fibrosis, immunosuppression);
✕. Less than 14 days since the last episode of respiratory tract infection;
✕. Confirmed pregnancy and/or breastfeeding;
✕. 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;
✕. Inability to obtain informed consent;
What they're measuring
1
Days alive out of hospital (superiority endpoint), within 14 days after study enrolment
Timeframe: 14 days
2
Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment