Respiratory Tract InfectionsADEQUATENCT04547556
ADEQUATE Advanced Diagnostics for Enhanced Quality of Antibiotic Prescription
A study testing BioFire in people with Respiratory Tract Infections, run by UMC Utrecht at 4 sites in 3 countries.
Trial summary
To assess the impact of rapid diagnostic testing of patients with Acute Respiratory Tract Infection (ARTI) at the emergency department, on (1) hospital admission rates and (2) antimicrobial prescriptions (days of treatment) and (3) the non-inferiority in terms of clinical outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- BioFire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 25 Oct 2021to 21 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years old) presenting to the Emergency Room with an acute illness (present for 14 days or less) with cough, and with at least 1 other lower respiratory tract symptom or clinical sign at physical examination:
- Sputum production,
- Breathlessness,
- Chest discomfort or chest pain,
- Wheeze,
- Crackles,
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- Self-reported dystermia or documented fever;
- Documented hypoxemia (adjusting definition for chronic oxygen therapy users, method of measurement) and no alternative explanation (infection, such as sinusitis; other, such as asthma).
- 2. Managing medical team considers:
- to treat patient with antibiotics and/or to hospitalize patient
- AND
- that the rapid syndromic diagnostic test result can be awaited up to a maximum of 4 hours before the decision to discharge the patient or to initiate antibiotic therapy.
Who cannot join
- Development of ARTI more than 48 hours after hospital admission (hospital acquired);
- Patients with cystic fibrosis;
- Less than 14 days since the last episode of respiratory tract infection;
- Pregnancy (confirmed by pregnancy test) and 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 from a competent patient.
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- Based on standard of care microbiological diagnosis and thoracic imaging (when indicated):
- Radiologically confirmed acute lobar pneumonia;
- Known or suspected Pneumocystis jirovecii pneumonia or active tuberculosis;
- Alternative noninfectious diagnosis that explains clinical symptoms (pulmonary embolism, alveolar hemorrhage, acute heart failure, lung cancer).
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Serbia2 sites
Clinical Center of Serbia
Belgrade
General Hospital Kragujevac
Kragujevac
About this study
Official title: ADEQUATE Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms
To assess the impact of rapid diagnostic testing of patients with Acute Respiratory Tract Infection (ARTI) at the emergency department, on (1) hospital admission rates and (2) antimicrobial prescriptions (days of treatment) and (3) the non-inferiority in terms of clinical outcome. Geographical and seasonal variation will be assessed on a real time basis including pathogens of public health interest. The impact will be stratified within age groups and risk factors in order to determine the long-term clinical, public health and economic determinants for the integration of diagnostics in a global and sustainable perspective.
Read the detailed description
Objective: To assess the impact of rapid diagnostic testing of patients with Acute Respiratory Tract Infection (ARTI) at the emergency department, on (1) hospital admission rates and (2) antibiotic prescriptions (days of treatment) and (3) the non-inferiority in terms of clinical outcome. Geographical and seasonal variation will be assessed on a real time basis including pathogens of public health interest. The impact will be stratified within age groups and risk factors in order to determine the long-term clinical, public health and economic determinants for the integration of diagnostics in a global and sustainable perspective.
Study design: Prospective, multi-center, individually randomised, controlled trial.
Study population: Adults (≥18 years old) consulting in selected participating sites with CA-ARTI.
Study Intervention: The diagnostic intervention is rapid syndromic testing with:
- BioFire FilmArray Pneumonia Panel plus (PP): Sputum (and/or ETA or BAL sample)
- BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus): Nasopharyngeal swab
Main study parameters/endpoints:
- Days alive out of hospital (superiority endpoint), within 14 days
- Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 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 within 30 days Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in the study involves collection of data that can be obtained from medical charts and follow up questionnaires and interviews. Respiratory samples (e.g. nasopharyngeal swab, sputum) will be obtained as standard of care and diagnostic intervention (Biofire FilmArray) will be used only for participants randomised to the intervention,Based on the results of diagnostic testing (BioFire FilmArray) antibiotics may be withheld when deemed unnecessary, or a different antibiotic class may be selected when certain bacterial pathogens are detected. The risks and benefits of management decisions, complemented with adequate training, are subject to the current investigation.
- Conditions
- Respiratory Tract Infections
- Being tested
- BioFire
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFireDiagnostic test
A molecular rapid syndromic testing platform, using the following panels:
- BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)
- BioFire FilmArray Pneumonia Panel plus (PP)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Diagnostic intervention Receives: Diagnostic Test: BioFire |
| Standard of Care | No intervention | Standard of care testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days Alive Out of Hospital (Superiority Endpoint)
Days alive out of hospital (superiority endpoint), within 14 days after study enrolment
Measured: Day 1 - Day 14
Days on Therapy (DOT) With Antibiotics (Superiority Endpoint)
Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment
Measured: Day 1 - Day 14
Adverse Outcome (Non-inferiority Safety Endpoint)
- For initially non-admitted patients: any admission or death
- For initially hospitalized patients: any readmission, ICU admission >= 24 hours after hospitalization, or death
Measured: Day 1 - Day 30
Secondary outcomes (6)
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: Day 1 - Day 30
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.
Data refers to the number of participants so in case more than one microorganism is detected in the same sample (co-detection) or same result in more than one sample, it is still counted as one participant.
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).
For this report, results are defined as non first-line if the choice includes a third or fourth generation cephalosporin or a carbapenem but analysis needs to be adjusted to baseline risk factors, comorbidities, local guidelines and time to de escalation.
Measured: Day 1 - Day 14
Antibiotic Type Switches and De-escalation Based on Antimicrobial Agent Categories
For this report is presented the number of patients where the antimicrobial was switched to narrower spectrum.
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 comparing diagnostic intervention arm and standard of care arm.
Measured: >7 days after randomisation
Impact on Decisions Regarding Isolation Measures Related to Test Result.
Hours in individual or cohort isolation in hospitalised participants comparing the 2 groups
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 posted14 Sep 2020
- Study start25 Oct 2021
- Primary completion21 May 2022
- Study completion21 May 2022
Why it stopped: Difficult recruitment in the context of the pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Principal investigator, Dr. Cristina Prat, UMC Utrecht
- Investigators
- Marc Bonten, MD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547556
- Sponsor's protocol ID
- WP4b - adults
- Acronym
- ADEQUATE
- Status last verified
- Oct 2024
- First submitted
- 7 Sep 2020
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. 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
- ClinicalTrials.gov ID
- NCT04547556
- Acronym / sponsor ID
- ADEQUATE / WP4b - adults
- Conditions
- Respiratory Tract Infections
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult recruitment in the context of the pandemic.
- Enrolment
- 185 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 21 May 2022 (actual)
- Study completion
- 21 May 2022 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the impact of rapid diagnostic testing of patients with Acute Respiratory Tract Infection (ARTI) at the emergency department, on (1) hospital admission rates and (2) antimicrobial prescriptions (days of treatment) and (3) the non-inferiority in terms of clinical outcome. Geographical and seasonal variation will be assessed on a real time basis including pathogens of public health interest. The impact will be stratified within age groups and risk factors in order to determine the long-term clinical, public health and economic determinants for the integration of diagnostics in a global and sustainable perspective.
Detailed description
Objective: To assess the impact of rapid diagnostic testing of patients with Acute Respiratory Tract Infection (ARTI) at the emergency department, on (1) hospital admission rates and (2) antibiotic prescriptions (days of treatment) and (3) the non-inferiority in terms of clinical outcome. Geographical and seasonal variation will be assessed on a real time basis including pathogens of public health interest. The impact will be stratified within age groups and risk factors in order to determine the long-term clinical, public health and economic determinants for the integration of diagnostics in a global and sustainable perspective.
Study design: Prospective, multi-center, individually randomised, controlled trial.
Study population: Adults (≥18 years old) consulting in selected participating sites with CA-ARTI.
Study Intervention: The diagnostic intervention is rapid syndromic testing with:
- BioFire FilmArray Pneumonia Panel plus (PP): Sputum (and/or ETA or BAL sample)
- BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus): Nasopharyngeal swab
Main study parameters/endpoints:
- Days alive out of hospital (superiority endpoint), within 14 days
- Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 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 within 30 days Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in the study involves collection of data that can be obtained from medical charts and follow up questionnaires and interviews. Respiratory samples (e.g. nasopharyngeal swab, sputum) will be obtained as standard of care and diagnostic intervention (Biofire FilmArray) will be used only for participants randomised to the intervention,Based on the results of diagnostic testing (BioFire FilmArray) antibiotics may be withheld when deemed unnecessary, or a different antibiotic class may be selected when certain bacterial pathogens are detected. The risks and benefits of management decisions, complemented with adequate training, are subject to the current investigation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: BioFireDiagnostic intervention |
| Standard of Care | No intervention | –Standard of care testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults (≥18 years old) presenting to the Emergency Room with an acute illness (present for 14 days or less) with cough, and with at least 1 other lower respiratory tract symptom or clinical sign at physical examination:
- AND
Key exclusion criteria (10 listed)
- Development of ARTI more than 48 hours after hospital admission (hospital acquired);
- Patients with cystic fibrosis;
- Less than 14 days since the last episode of respiratory tract infection;
- Pregnancy (confirmed by pregnancy test) and 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 |
|---|---|---|
| BioFireA molecular rapid syndromic testing platform, using the following panels: * BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus) * BioFire FilmArray Pneumonia Panel plus (PP) | Diagnostic test | Intervention |
Primary outcome
Days Alive Out of Hospital (Superiority Endpoint)
Time frame: Day 1 - Day 14
Days alive out of hospital (superiority endpoint), within 14 days after study enrolment
Days on Therapy (DOT) With Antibiotics (Superiority Endpoint)
Time frame: Day 1 - Day 14
Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment
Adverse Outcome (Non-inferiority Safety Endpoint)
Time frame: Day 1 - Day 30
* For initially non-admitted patients: any admission or death * For initially hospitalized patients: any readmission, ICU admission >= 24 hours after hospitalization, or death
6 secondary outcomes
Direct Costs and Indirect Costs Within 30 Days After Enrolment.
Time frame: Day 1 - Day 30
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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marc Bonten, MD principal investigator
UMC Utrecht
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioFire in people with Respiratory Tract Infections, run by UMC Utrecht at 4 sites in 3 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 10 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: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Serbia, Belgium, Hungary. 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?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) (time frame: Day 1 - Day 14). 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?
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 15 Oct 2024.