ADEQUATE Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms - Paediatric (ADEQUATE)
Community-acquired Acute Lower Respiratory Infection
About this trial
This is an interventional diagnostic trial for Community-acquired Acute Lower Respiratory Infection focused on measuring community-acquired pneumonia, point-of-care test, rapid diagnostics
Eligibility Criteria
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
AND at least two of the below:
- Cough
- Abnormal sounds on chest auscultation (crackles, reduced breath sounds, bronchial breathing, wheezing)
- Clinical signs of dyspnea (chest indrawing, nasal flaring, grunting)
- Signs of respiratory dysfunction: tachypnoea for age or decreased oxygen saturation (<92% in room air)
- Signs of reduced general state: poor feeding, vomiting or lethargy/drowsiness
At time of screening:
- Patient has undergone first assessment by managing clinical team (doctor or nurse, incl. triage)
- Hospitalisation is not yet determined, i.e. neither by clinical presentation definitely requiring hospitalisation (e.g. per local guideline) nor by fixed decision of managing clinical team; admission to a short-stay unit or surveillance unit is not considered a hospitalisation for this trial
- Antibiotic treatment or hospitalisation is being considered
- The rapid syndromic diagnostic test result can be awaited for up to 4 hours before the decision to discharge the patient or to initiate antibiotic treatment is made
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;
- Alternative noninfectious diagnosis that explains clinical symptoms.
Sites / Locations
- University Children's Hospital Basel (UKBB)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention (Device)
Control (Standard of Care)
Diagnostic Test: BioFire A molecular rapid syndromic testing platform, using the following panel: BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus) In addition to standard of care
Standard of Care