Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-04-21 @ 3:37 PM
Study NCT ID:
NCT04547556
Status:
TERMINATED
Last Update Posted:
2024-10-15
First Post:
2020-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ADEQUATE Advanced Diagnostics for Enhanced Quality of Antibiotic Prescription
Sponsor:
UMC Utrecht
Organization:
Study Overview
Official Title:
ADEQUATE Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficult recruitment in the context of the pandemic.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADEQUATE
Brief 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. 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: 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: