Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576258
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
The Clinical Impact of Cobas Eplex Blood Culture Panels for the Diagnosis of Bacteremia and Fungemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Clinical Impact of Cobas Eplex Blood Culture Panels for the Diagnosis of Bacteremia and Fungemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A quality improvement study on the diagnostics and clinical management of bloodstream infection episodes Patients of all ages and genders with positive blood cultures collected for standard patient care are included in the study In the intervention group of patients positive blood cultures will be analysed with the cobas eplex Roche blood culture panels in addition to conventional standard-of-care SOC culture methods The control group will include patients with positive blood cultures analysed using conventional standard-of-care SOC culture methods The study aims to determine the effect of rapid molecular testing using the cobas eplex blood culture panels Roche in the clinical management of bloodstream infections and more specifically the effect of the eplex result on the time to most effectivetargeted antibiotic treatment The primary objective is to investigate the difference in time to most effective antibiotic treatment between the control and intervention group The secondary aims are to analyze the concordance of results and compare the user-friendliness hands-on time and turnaround times of the eplex to the SOC culture methods as well as to compare the difference in the length of stay antibiotic intensity score at 96h after Gram staining and patient outcome 30-day all cause mortality and 30-day readmission in the control and intervention group
Detailed Description:
Bloodstream infections BSIs impose a considerable burden on patients and healthcare systems due to the need for hospital admission extended stays additional diagnostic tests and specific treatments Receiving inappropriate empirical antibiotic therapy can increase the risk of renal and hepatic toxicity antibiotic resistance opportunistic infections and mortality Therefore early identification of the causative pathogens and their resistance patterns is of utmost importance
The gold standard for diagnosis of BSIs is through blood cultures To detect bacteremia or fungemia blood from patients is collected and incubated in blood culture bottles When using conventional culture methods a positive blood bottle is investigated using direct microscopic investigation gram-staining inoculation of selective and non-selective agars MALDI-TOF identification rapid antimicrobial susceptibility testing AST and standardized AST methods These methods require several manual steps and days of turn-around-time Following the collection of a blood culture time to result depends on several factors such as the time needed for transporting the blood bottles and loading in the incubator the growth rate of bacteria or fungi as well as the time to obtain the identification and AST result
Rapid diagnostic tests to improve the time to appropriate antimicrobial therapy have been developed Most tests involve organism identification and genotypic resistance profiles Rapid molecular diagnostic testing such as multiplex PCR methods enable early identification of bacteria or fungi and their antimicrobial resistance genes results within less than 2 hours after initiation of the test This helps minimize the time needed to initiate effective antimicrobial therapy Commercial diagnostic systems to accelerate the identification and detection of antibiotic resistance genes of causative pathogens in BSI have been developed Examples include Cepheid GeneXpert BioFire FilmArrayTM and Roche eplex The system used in this study the eplex system is a random access multiplex PCR platform combining extraction of nucleic acids and rapid RT-PCR Three Blood Culture Identification BCID panels are used to identify the disease-causing organisms Gram-positive panel Gram-negative panel and Fungal Pathogen panel These panels are designed to detect 56 different organisms covering 95 of pathogens commonly associated with BSIs and 10 common antibiotic resistance genes
The objective of this study is to assess the impact of rapid molecular testing on positive blood cultures with the cobas eplex system Roche on antibiotic therapy and patient outcome
In this study we prospectively evaluate the performance of the eplex system for pathogen identification and detection of resistance markers compared to routine SOC for bloodstream infections The potential impact of the eplex on time to optimization inititiation discontinuation escalation or de-escalation of antimicrobial therapy and patient outcome will be evaluated
In summary Finally this study will evaluate the potential benefits of implementing CE-IVD registered syndromic diagnostic testing of bloodstream infections
The gold standard for diagnosis of BSIs is through blood cultures To detect bacteremia or fungemia blood from patients is collected and incubated in blood culture bottles When using conventional culture methods a positive blood bottle is investigated using direct microscopic investigation gram-staining inoculation of selective and non-selective agars MALDI-TOF identification rapid antimicrobial susceptibility testing AST and standardized AST methods These methods require several manual steps and days of turn-around-time Following the collection of a blood culture time to result depends on several factors such as the time needed for transporting the blood bottles and loading in the incubator the growth rate of bacteria or fungi as well as the time to obtain the identification and AST result
Rapid diagnostic tests to improve the time to appropriate antimicrobial therapy have been developed Most tests involve organism identification and genotypic resistance profiles Rapid molecular diagnostic testing such as multiplex PCR methods enable early identification of bacteria or fungi and their antimicrobial resistance genes results within less than 2 hours after initiation of the test This helps minimize the time needed to initiate effective antimicrobial therapy Commercial diagnostic systems to accelerate the identification and detection of antibiotic resistance genes of causative pathogens in BSI have been developed Examples include Cepheid GeneXpert BioFire FilmArrayTM and Roche eplex The system used in this study the eplex system is a random access multiplex PCR platform combining extraction of nucleic acids and rapid RT-PCR Three Blood Culture Identification BCID panels are used to identify the disease-causing organisms Gram-positive panel Gram-negative panel and Fungal Pathogen panel These panels are designed to detect 56 different organisms covering 95 of pathogens commonly associated with BSIs and 10 common antibiotic resistance genes
The objective of this study is to assess the impact of rapid molecular testing on positive blood cultures with the cobas eplex system Roche on antibiotic therapy and patient outcome
In this study we prospectively evaluate the performance of the eplex system for pathogen identification and detection of resistance markers compared to routine SOC for bloodstream infections The potential impact of the eplex on time to optimization inititiation discontinuation escalation or de-escalation of antimicrobial therapy and patient outcome will be evaluated
In summary Finally this study will evaluate the potential benefits of implementing CE-IVD registered syndromic diagnostic testing of bloodstream infections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None