Trial Outcomes & Findings for ADEQUATE Advanced Diagnostics for Enhanced Quality of Antibiotic Prescription (NCT NCT04547556)
NCT ID: NCT04547556
Last Updated: 2024-10-15
Results Overview
Days alive out of hospital (superiority endpoint), within 14 days after study enrolment
TERMINATED
NA
185 participants
Day 1 - Day 14
2024-10-15
Participant Flow
Participant milestones
| Measure |
Intervention
BioFire: 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)
|
Standard of Care
Standard of care diagnostics
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
93
|
|
Overall Study
COMPLETED
|
92
|
93
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention
n=92 Participants
BioFire: 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)
|
Standard of Care
n=93 Participants
Standard of care diagnostic testing
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.5 years
n=92 Participants
|
67 years
n=93 Participants
|
67 years
n=185 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=92 Participants
|
45 Participants
n=93 Participants
|
91 Participants
n=185 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=92 Participants
|
48 Participants
n=93 Participants
|
94 Participants
n=185 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Serbia
|
88 participants
n=92 Participants
|
91 participants
n=93 Participants
|
179 participants
n=185 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=92 Participants
|
2 participants
n=93 Participants
|
5 participants
n=185 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=92 Participants
|
0 participants
n=93 Participants
|
1 participants
n=185 Participants
|
PRIMARY outcome
Timeframe: Day 1 - Day 14Population: Days alive out of hospital
Days alive out of hospital (superiority endpoint), within 14 days after study enrolment
Outcome measures
| Measure |
Intervention
n=92 Participants
BioFire: 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)
|
Standard of Care
n=93 Participants
Standard of Care diagnostic testing
|
|---|---|---|
|
Days Alive Out of Hospital (Superiority Endpoint)
|
10.7 days
Standard Deviation 5.3
|
9.7 days
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: Day 1 - Day 14Population: Number of antibiotic treatment days
Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment
Outcome measures
| Measure |
Intervention
n=92 Participants
BioFire: 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)
|
Standard of Care
n=93 Participants
Standard of Care diagnostic testing
|
|---|---|---|
|
Days on Therapy (DOT) With Antibiotics (Superiority Endpoint)
|
6.7 days
Standard Deviation 4.6
|
7 days
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Intervention
n=92 Participants
BioFire: 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)
|
Standard of Care
n=93 Participants
Standard of Care diagnostic testing
|
|---|---|---|
|
Adverse Outcome (Non-inferiority Safety Endpoint)
|
9 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 1 - Day 30Population: This outcome will not be analysed since direct costs and indirect costs could not be properly collected. Cost effective algorithms might change with factors as the disease incidence changes, performance of other diagnostic tests or its combination. As these other factors are also dependent on country and vary over time, the data as collected in the trial is insufficient to reliably report on cost-effectiveness in general
* 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1Population: Data collected includes: sample type (upper and lower respiratory tract samples for diagnostic intervention but also blood cultures and urinary antigen tests for standard of care if applicable), type of diagnostic test, specific results. Data is also collected regarding the time elapsed until the results were received. Results are final for this trial and later on will be compared with pediatric trial results NCT04781530.
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.
Outcome measures
| Measure |
Intervention
n=92 Participants
BioFire: 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)
|
Standard of Care
n=93 Participants
Standard of Care diagnostic testing
|
|---|---|---|
|
Microbiological Results Obtained as Standard of Care and With the Diagnostic Intervention
|
58 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Day 1 - Day 14Population: Final analysis needs to integrate data from both the adult and the pediatric protocol and to adjust to local guidelines per country as well as risk factors and comorbidities. Data collected includes: antibiotics, antivirals and antifungals recording if initial, switch or addition to ongoing therapy as well as route of administration, dosing interval and start and stop date.
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.
Outcome measures
| Measure |
Intervention
n=92 Participants
BioFire: 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)
|
Standard of Care
n=93 Participants
Standard of Care diagnostic testing
|
|---|---|---|
|
Empirical Antibiotics Based on Antimicrobial Agent Categories
|
30 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Day 1 - Day 14Population: Final analysis needs to integrate data from both the adult and the pediatric protocol and to adjust to local guidelines per country as well as risk factors and comorbidities. Data collected includes: antibiotics, antivirals and antifungals recording if initial, switch or addition to ongoing therapy as well as route of administration, dosing interval and start and stop date.
For this report is presented the number of patients where the antimicrobial was switched to narrower spectrum.
Outcome measures
| Measure |
Intervention
n=92 Participants
BioFire: 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)
|
Standard of Care
n=93 Participants
Standard of Care diagnostic testing
|
|---|---|---|
|
Antibiotic Type Switches and De-escalation Based on Antimicrobial Agent Categories
|
11 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: >7 days after randomisationPopulation: Hospitalised participants. Samples obtained as standard of care during hospital stay. Detection of multidrug resistant microorganism was recorded.
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.
Outcome measures
| Measure |
Intervention
n=27 Participants
BioFire: 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)
|
Standard of Care
n=32 Participants
Standard of Care diagnostic testing
|
|---|---|---|
|
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.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 - Day 30Population: Hospitalised participants. Data collected includes start and stop date of individual or cohort isolation. Isolation measures in the current cohort were related to SARS-CoV-2 infection and not to the detection of multidrug resistant bacteria.
Hours in individual or cohort isolation in hospitalised participants comparing the 2 groups
Outcome measures
| Measure |
Intervention
n=27 Participants
BioFire: 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)
|
Standard of Care
n=32 Participants
Standard of Care diagnostic testing
|
|---|---|---|
|
Impact on Decisions Regarding Isolation Measures Related to Test Result.
|
0 hours in isolation
Standard Deviation 0
|
0 hours in isolation
Standard Deviation 0
|
Adverse Events
Intervention
Standard of Care
Serious adverse events
| Measure |
Intervention
n=92 participants at risk
BioFire: 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)
|
Standard of Care
n=93 participants at risk
Standard of Care testing
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/92 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
1.1%
1/93 • Number of events 1 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
|
Cardiac disorders
Cardiac arrest
|
4.3%
4/92 • Number of events 4 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
10.8%
10/93 • Number of events 10 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/92 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
1.1%
1/93 • Number of events 1 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/92 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
1.1%
1/93 • Number of events 1 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/92 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
1.1%
1/93 • Number of events 1 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.1%
1/92 • Number of events 1 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
0.00%
0/93 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
Other adverse events
| Measure |
Intervention
n=92 participants at risk
BioFire: 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)
|
Standard of Care
n=93 participants at risk
Standard of Care testing
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/92 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
1.1%
1/93 • Number of events 1 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/92 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
1.1%
1/93 • Number of events 1 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
|
Respiratory, thoracic and mediastinal disorders
COVID 19
|
0.00%
0/92 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
1.1%
1/93 • Number of events 1 • From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).
Standard definitions of adverse events and device related events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place