Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478953
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-23
Brief Title:
Impact of Rapid Pathogen Detection in ICU Patients With Suspected Pneumonia on Antimicrobial Therapy
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Impact of Rapid Pathogen Detection in ICU Patients With Suspected Pneumonia on Antimicrobial Therapy a Pilot Randomized Controlled Open-label Feasibility Trial IRISPAT-1
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRISPAT-1
Brief Summary:
The goal of this intervention trial is to determine the feasibility safety and potential impact of rapid respiratory pathogen detection by FA Pneumonia Panel on antibiotic therapy in mechanically ventilated critically ill patients with suspected pneumonia
Participants will randomized to either have an urgent BioFire FA Pneumonia Panel assay performed or recieve standard of care to guide antimicrobial therapy and treatment of pneumonia
Participants will randomized to either have an urgent BioFire FA Pneumonia Panel assay performed or recieve standard of care to guide antimicrobial therapy and treatment of pneumonia
Detailed Description:
Pneumonia is the most common cause of sepsis requiring admission to the intensive care unit ICU Molecular pathogen detection techniques such as polymerase chain reaction PCR may help optimize antimicrobial therapy Its utility for diagnosing respiratory viral infections such as influenza is well established and was an essential diagnostic tool during the coronavirus 2019 COVID-19 pandemic However its use remains limited for bacterial pathogens The rationale to use PCR based bacterial detection to facilitate antibiotic stewardship is threefold First it may shorten the time to pathogen detection Second it has improved sensitivity over conventional culture techniques particularly for pathogens that are difficult to culture Third it can detect resistant genes to inform antimicrobial sensitivity Taken together utilization of bacterial PCR may shorten time to appropriate antimicrobial therapy and minimize injudicious use of broad-spectrum antimicrobials in patients who do not have infection from MDRO
The BioFire FilmArray Pneumonia Panel FA Pneumonia Panel is a PCR based in vitro assay which rapidly identifies 8 viral and 18 bacterial common pathogens in tracheal aspirate and bronchoalveolar lavage BAL samples Clinical studies showed that FA Pneumonia Panel on BAL specimens have sensitivity of 75 to 100 and specificity of 91 for the pathogens tested Retrospective analysis suggests utilizing FA Pneumonia Panel may facilitate discontinuation or de-escalation of antimicrobials in 48 of patients with an average reduction of 6 antibiotic days However currently there are no randomized controlled trials that assessed the efficacy of FA Pneumonia Panel on improving antimicrobial stewardship
Addition of FA Pneumonia Panel to standard care should shorten time to pathogen and resistance detection enhance sensitivity over conventional microbiological cultures and shorten time to appropriate antimicrobial therapy by reducing over-narrow and over-broad coverage Robust clinical trials are now needed to test these hypotheses We propose to conduct a pilot randomized controlled open-label trial designed to determine the feasibility safety and potential impact of rapid respiratory pathogen detection by FA Pneumonia Panel on antibiotic therapy in 40 mechanically ventilated critically ill patients with suspected pneumonia
The goal is to determine the feasibility safety and potential impact of rapid respiratory pathogen detection by BioFire FilmArray Pneumonia Panel on antimicrobial therapy in 40 mechanically ventilated critically ill patients with suspected pneumonia
The BioFire FilmArray Pneumonia Panel FA Pneumonia Panel is a PCR based in vitro assay which rapidly identifies 8 viral and 18 bacterial common pathogens in tracheal aspirate and bronchoalveolar lavage BAL samples Clinical studies showed that FA Pneumonia Panel on BAL specimens have sensitivity of 75 to 100 and specificity of 91 for the pathogens tested Retrospective analysis suggests utilizing FA Pneumonia Panel may facilitate discontinuation or de-escalation of antimicrobials in 48 of patients with an average reduction of 6 antibiotic days However currently there are no randomized controlled trials that assessed the efficacy of FA Pneumonia Panel on improving antimicrobial stewardship
Addition of FA Pneumonia Panel to standard care should shorten time to pathogen and resistance detection enhance sensitivity over conventional microbiological cultures and shorten time to appropriate antimicrobial therapy by reducing over-narrow and over-broad coverage Robust clinical trials are now needed to test these hypotheses We propose to conduct a pilot randomized controlled open-label trial designed to determine the feasibility safety and potential impact of rapid respiratory pathogen detection by FA Pneumonia Panel on antibiotic therapy in 40 mechanically ventilated critically ill patients with suspected pneumonia
The goal is to determine the feasibility safety and potential impact of rapid respiratory pathogen detection by BioFire FilmArray Pneumonia Panel on antimicrobial therapy in 40 mechanically ventilated critically ill patients with suspected pneumonia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None