Status:
COMPLETED
Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms
Lead Sponsor:
PENTA Foundation
Collaborating Sponsors:
BioMérieux
Universiteit Antwerpen
Conditions:
Community-acquired Acute Lower Respiratory Infection
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief Summary
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. Fol...
Detailed Description
Background. Community-acquired acute respiratory tract infections (CA-ARTI) are among the most frequent infectious diseases worldwide. Uncomplicated ARTI is the most frequent cause of inappropriate an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2024
Estimated Enrollment :
522 Patients enrolled
Trial Details
Trial ID
NCT04781530
Start Date
July 7 2021
End Date
January 25 2024
Last Update
April 18 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
University Children's Hospital Tuebingen
Tübingen, Germany
2
Hippokration Hospital of Thessaloniki
Thessaloniki, Greece
3
Hospital Universitario 12 de Octubre, Spain
Madrid, Spain
4
University Children's Hospital Basel (UKBB)
Basel, Canton of Basel-City, Switzerland, 4056