Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04547556
Status:
TERMINATED
Last Update Posted:
2022-11-10
First Post:
2020-09-07
Brief Title:
ADEQUATE Advanced Diagnostics for Enhanced Quality of Antibiotic Prescription
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
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 andor ETA or BAL sample
BioFire FilmArray Respiratory Panel 21 plus RP21plus Nasopharyngeal swab
Main study parametersendpoints
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 eg nasopharyngeal swab sputum will be obtained as standard of care and diagnostic intervention Biofire FilmArray will be used only for participants randomised to the interventionBased 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 andor ETA or BAL sample
BioFire FilmArray Respiratory Panel 21 plus RP21plus Nasopharyngeal swab
Main study parametersendpoints
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 eg nasopharyngeal swab sputum will be obtained as standard of care and diagnostic intervention Biofire FilmArray will be used only for participants randomised to the interventionBased 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:
None
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?:
None