Community-acquired Acute Lower Respiratory InfectionADEQUATENCT04781530
Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms
A study testing BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus) in people with Community-acquired Acute Lower Respiratory Infection, run by PENTA Foundation at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Community-acquired Acute Lower Respiratory Infection
- What is being tested?
- BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 7 Jul 2021to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Switzerland2 sites
University Children's Hospital Basel (UKBB)
Basel, Canton of Basel-City, 4056
Ospedale Regionale Bellinzona e Valli
Bellinzona
About this study
Official title: ADEQUATE Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms - Paediatric
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.
Read the 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 antibiotic use, and there is a need of more judicious antibiotic prescribing to prevent exposure to drug-related adverse events and selection of antibiotic resistance. There is a need to assess the impact of rapid syndromic diagnostic testing in patients with CA-ARTI presenting to Emergency Rooms on clinical decision making related to hospitalisation and prescription of antibiotics. At the same time it must be determined whether the decisions guided by the rapid syndromic diagnostic testing results do not compromise patient safety.
Trial objective: To assess the impact of rapid diagnostic testing in patients with ARTI at the emergency department, on (1) hospital admission rates, (2) antimicrobial prescriptions (days of treatment) and (3) non-inferiority in terms of clinical outcome.
Secondary objectives include health care utilisation, time away from school or routine childcare arrangements and quality of life.
In an ancillary study, changing patterns in microbiological colonisation of the oropharynx following different management strategies will be assessed in a subset of participants.
Study design: Individually randomised controlled trial, randomisation 1:1 to either a rapid test group (intervention described below) or a control group, with management according to standard of care at the local facility. Follow-up until discharge from hospital and thereafter by telephone follow-up and self (or proxy)-completion questionnaires until 30 days after randomisation.
Study population: Children of any age consulting in selected participating sites with CA-ARTI, in which there is initial uncertainty about treatment and management decisions, after provision of informed consent by parent(s) or legal guardian.
Study Intervention: The diagnostic intervention is rapid syndromic testing on a nasopharyngeal swab with BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus) (licensed for routine use at all trial sites), results expected within four hours from sample collection.
Co-primary endpoints:
Hierarchical nested analysis design of:
- Days alive out of hospital (superiority endpoint), within 14 days after study enrolment
- Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment
Secondary endpoints Adverse outcome (non-inferiority safety endpoint)
•Safety endpoint: For initially hospitalised patients: i) any readmission, ii) ICU admission => 24 hours after hospitalisation, or iii) death, within 30 days after study enrolment
For initially non-admitted patients: any admission or death within 30 days after study enrolment.
- Direct costs and indirect costs within 30 days after enrolment.
- Change in quality of life as determined by EQ-5D-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.
- Microbiological results obtained as standard of care and with the diagnostic intervention
- Empirical antibiotics, antibiotic type switches, de-escalation based on antimicrobial agent categories. Prescription of antivirals during the main study.
- Detection of antimicrobial resistance (carriage or infection) related to the diagnostic intervention results compared to standard of care and impact on antimicrobial stewardship guidelines and prevention of hospital acquired infections.
- Impact on decisions regarding isolation measures related to test result.
- Being tested
- BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)
- Keywords
- community-acquired pneumonia, point-of-care test, rapid diagnostics
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)Device
BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus): Nasopharyngeal swab
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus) |
| Control (Standard of Care) | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 30 days
Secondary outcomes (7)
Direct costs and indirect costs within 30 days after enrolment.
- Cost of healthcare within 30 days after enrolment, including hospital and ICU days, utilisation of non-hospital services and cost of anti-infective and concomitant medication
- Cost of workdays lost within 30 days, including days for childcare
Measured: 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.
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.
Measured: 1, 14 and 30 days
Microbiological results obtained as standard of care and with the diagnostic intervention
Proportion of participants with an identified respiratory pathogen in both study groups on randomisation day samples.
Measured: Day 1
Empirical antibiotics based on antimicrobial agent categories
Proportion of participants on non-first-line anti-infective regimens (as defined by local guidelines)
Measured: Day 1 - Day 14
Antibiotic type switches and de-escalation based on antimicrobial agent categories
Time to de-escalation and time to stop of anti-infective therapy
Measured: Day 1 - Day 14
Detection of antimicrobial resistance (carriage or infection) related to the diagnostic intervention results compared to standard of care and impact on antimicrobial stewardship guidelines and prevention of hospital acquired infections
Proportion of hospitalised participants with detection of cephalosporin-, carbapenem- or chinolone-resistant Enterobacteriaceae on any standard of care samples >7 days after randomisation
Measured: >7 days after randomisation
Impact on decisions regarding isolation measures related to test result.
Hours in individual or cohort isolation in hospitalised participants
Measured: Day 1 - Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start7 Jul 2021
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-acquired Acute Lower Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- PENTA Foundation
- Sponsor type
- Research network
- Collaborators
- BioMérieux, Universiteit Antwerpen, St George's, University of London, University Children's Hospital Basel
- Responsible party
- Sponsor
- Investigators
- Julia Bielicki, PhD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781530
- Sponsor's protocol ID
- ADEQUATE
- Acronym
- ADEQUATE
- Status last verified
- Dec 2024
- First submitted
- 2 Feb 2021
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38670622
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADEQUATE Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms - Paediatric
- ClinicalTrials.gov ID
- NCT04781530
- Acronym / sponsor ID
- ADEQUATE / ADEQUATE
- Keywords
- community-acquired pneumonia, point-of-care test, rapid diagnostics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- PENTA FoundationResearch network
- Collaborators
- BioMérieux, Universiteit Antwerpen, St George's, University of London, University Children's Hospital Basel
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 antibiotic use, and there is a need of more judicious antibiotic prescribing to prevent exposure to drug-related adverse events and selection of antibiotic resistance. There is a need to assess the impact of rapid syndromic diagnostic testing in patients with CA-ARTI presenting to Emergency Rooms on clinical decision making related to hospitalisation and prescription of antibiotics. At the same time it must be determined whether the decisions guided by the rapid syndromic diagnostic testing results do not compromise patient safety.
Trial objective: To assess the impact of rapid diagnostic testing in patients with ARTI at the emergency department, on (1) hospital admission rates, (2) antimicrobial prescriptions (days of treatment) and (3) non-inferiority in terms of clinical outcome.
Secondary objectives include health care utilisation, time away from school or routine childcare arrangements and quality of life.
In an ancillary study, changing patterns in microbiological colonisation of the oropharynx following different management strategies will be assessed in a subset of participants.
Study design: Individually randomised controlled trial, randomisation 1:1 to either a rapid test group (intervention described below) or a control group, with management according to standard of care at the local facility. Follow-up until discharge from hospital and thereafter by telephone follow-up and self (or proxy)-completion questionnaires until 30 days after randomisation.
Study population: Children of any age consulting in selected participating sites with CA-ARTI, in which there is initial uncertainty about treatment and management decisions, after provision of informed consent by parent(s) or legal guardian.
Study Intervention: The diagnostic intervention is rapid syndromic testing on a nasopharyngeal swab with BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus) (licensed for routine use at all trial sites), results expected within four hours from sample collection.
Co-primary endpoints:
Hierarchical nested analysis design of:
- Days alive out of hospital (superiority endpoint), within 14 days after study enrolment
- Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment
Secondary endpoints Adverse outcome (non-inferiority safety endpoint)
•Safety endpoint: For initially hospitalised patients: i) any readmission, ii) ICU admission => 24 hours after hospitalisation, or iii) death, within 30 days after study enrolment
For initially non-admitted patients: any admission or death within 30 days after study enrolment.
- Direct costs and indirect costs within 30 days after enrolment.
- Change in quality of life as determined by EQ-5D-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.
- Microbiological results obtained as standard of care and with the diagnostic intervention
- Empirical antibiotics, antibiotic type switches, de-escalation based on antimicrobial agent categories. Prescription of antivirals during the main study.
- Detection of antimicrobial resistance (carriage or infection) related to the diagnostic intervention results compared to standard of care and impact on antimicrobial stewardship guidelines and prevention of hospital acquired infections.
- Impact on decisions regarding isolation measures related to test result.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Device) | Experimental | Device: BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)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 |
| Control (Standard of Care) | No intervention | –Standard of Care |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus): Nasopharyngeal swab | Device | Intervention (Device) |
Primary outcome
Days alive out of hospital (superiority endpoint), within 14 days after study enrolment
Time frame: 14 days
Days alive out of hospital (superiority endpoint), within 14 days after study enrolment
Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment
Time frame: 14 days
Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment
Adverse outcome (non-inferiority safety endpoint)
Time frame: 30 days
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
7 secondary outcomes
Direct costs and indirect costs within 30 days after enrolment.
Time frame: 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.
Time frame: 1, 14 and 30 days
Microbiological results obtained as standard of care and with the diagnostic intervention
Time frame: Day 1
Empirical antibiotics based on antimicrobial agent categories
Time frame: Day 1 - Day 14
Antibiotic type switches and de-escalation based on antimicrobial agent categories
Time frame: Day 1 - Day 14
Detection of antimicrobial resistance (carriage or infection) related to the diagnostic intervention results compared to standard of care and impact on antimicrobial stewardship guidelines and prevention of hospital acquired infections
Time frame: >7 days after randomisation
Impact on decisions regarding isolation measures related to test result.
Time frame: Day 1 - Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Derived from this study: PubMed 38670622ADEQUATE 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Bielicki, PhD principal investigator
St George's, University of London
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus) in people with Community-acquired Acute Lower Respiratory Infection, run by PENTA Foundation at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland, Germany, Greece, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days alive out of hospital (superiority endpoint), within 14 days after study enrolment (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04781530, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.