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

NCT04781530 | Completed DMC

• 1 other identifier: ADEQUATE
• Study Type: interventional
• Target: 522
• Locations: 5 countries
• Sites: 6

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. 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.

Conditions

Community-acquired Acute Lower Respiratory Infection

Keywords

community-acquired pneumonia; point-of-care test; rapid diagnostics

Outcome Measures

Primary Outcomes (3)

• Days alive out of hospital (superiority endpoint), within 14 days after study enrolment

  Days alive out of hospital (superiority endpoint), within 14 days after study enrolment

  14 days

• Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment

  Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment

  14 days

• Adverse outcome (non-inferiority safety endpoint)

  Adverse outcome (non-inferiority safety endpoint) * For initially non-admitted patients: any admission or death within 30 days * For initially hospitalised patients: i) any readmission, ii) ICU admission \>= 24 hours after hospitalisation, or iii) death, all within 30 days

  30 days

Secondary Outcomes (7)

• Direct costs and indirect costs within 30 days after enrolment.

  30 days

• Quality of life as determined by EQ5D-5L (or suitable alternative for age), days away from usual childcare routine or school and healthcare utilisation on day 1, 14, and 30 after enrolment.

  1, 14 and 30 days

• Microbiological results obtained as standard of care and with the diagnostic intervention

  Day 1

• Empirical antibiotics based on antimicrobial agent categories

  Day 1 - Day 14

• Antibiotic type switches and de-escalation based on antimicrobial agent categories

  Day 1 - Day 14

Study Arms (2)

Intervention (Device)

EXPERIMENTAL

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

Device: BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)

Control (Standard of Care)

NO INTERVENTION

Standard of Care

Interventions

BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus) DEVICE

BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus): Nasopharyngeal swab

Intervention (Device)

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PENTA Foundation: lead
• BioMérieux: collaborator
• Universiteit Antwerpen: collaborator
• St George's, University of London: collaborator
• University Children's Hospital Basel: collaborator

Study Sites (6)

University Children's Hospital Tuebingen

Tübingen, Germany

Location

Hippokration Hospital of Thessaloniki

Thessaloniki, Greece

Location

Hospital Universitario 12 de Octubre, Spain

Madrid, Spain

Location

University Children's Hospital Basel (UKBB)

Basel, Canton of Basel-City, 4056, Switzerland

Location

Ospedale Regionale Bellinzona e Valli

Bellinzona, Switzerland

Location

University Hospital of Lewisham

London, United Kingdom

Location

Related Publications (1)

• ADEQUATE Paediatric Trial Group. Randomised multicentre effectiveness trial of rapid syndromic testing by panel assay in children presenting to European emergency departments with acute respiratory infections-trial protocol for the ADEQUATE Paediatric trial. BMJ Open. 2024 Apr 25;14(4):e076338. doi: 10.1136/bmjopen-2023-076338.

  PMID: 38670622 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Julia Bielicki, PhD

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The trial is unblinded / open-label.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: March 4, 2021
• Study Start: July 7, 2021
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: April 18, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); GB (1); GR (1); CH (2); ES (1)