Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06132347
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-10-27
Brief Title:
Performances of DendrisCHIPOA in Bone and Joint Infections
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Performances of DendrisCHIPOA in Bone and Joint Infections
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
DENDRIS
Brief Summary:
Bone and joint infections BJI with and without prosthetic material knee hip and shoulder are complex to diagnose and treat justifying the creation of expert centers by the French Ministry of Health CRIOAc
In case of BJI with material the diagnosis is based on a set of clinical bacteriological cytological and radiological criteria known as the EBJIS 2021 European Bone Joint Infections Society criteria For septic arthritis diagnosis is based on bacteriology and cytology
Microbiology remains essential and the delay of obtention of microbiological results is crucial to adapt the antibiotic treatment Although culture-based microbiology remains the most common diagnosis of BJI its regular failure to identify the causative pathogen as well as its long-term modus operandi motivates the development of rapid and accurate molecular methods
The DendrisCHIPOA platform has demonstrated its ability to offer routine molecular identification of the current micro-organisms involved in BJI in less than 5 hours with the detection of mecA resistance genes on series of 16 to 64 samples The DendrisCHIPOA is CE-marked and has already been the subject of an initial publication evaluating its performance in a single center
The main objective of this study is to evaluate the diagnostic performances of the DendrisCHIPOA in detecting the pathogens recognized in its panel and the detection of the mecA gene compared with the routine microbiological techniques used in the inclusion centers participating to the study
The study aims to include 100 patients during 6 months in five inclusion centers in the Ile de France region
In case of BJI with material the diagnosis is based on a set of clinical bacteriological cytological and radiological criteria known as the EBJIS 2021 European Bone Joint Infections Society criteria For septic arthritis diagnosis is based on bacteriology and cytology
Microbiology remains essential and the delay of obtention of microbiological results is crucial to adapt the antibiotic treatment Although culture-based microbiology remains the most common diagnosis of BJI its regular failure to identify the causative pathogen as well as its long-term modus operandi motivates the development of rapid and accurate molecular methods
The DendrisCHIPOA platform has demonstrated its ability to offer routine molecular identification of the current micro-organisms involved in BJI in less than 5 hours with the detection of mecA resistance genes on series of 16 to 64 samples The DendrisCHIPOA is CE-marked and has already been the subject of an initial publication evaluating its performance in a single center
The main objective of this study is to evaluate the diagnostic performances of the DendrisCHIPOA in detecting the pathogens recognized in its panel and the detection of the mecA gene compared with the routine microbiological techniques used in the inclusion centers participating to the study
The study aims to include 100 patients during 6 months in five inclusion centers in the Ile de France region
Detailed Description:
Bone and joint infections BJI with and without prosthetic material knee hip and shoulder are complex to diagnose and treat justifying the creation of expert centers by the French Ministry of Health CRIOAc
In case of BJI with material the diagnosis is based on a set of clinical bacteriological cytological and radiological criteria known as the EBJIS 2021 European Bone Joint Infections Society criteria For septic arthritis diagnosis is based on bacteriology and cytology
Currently a patient with suspected BJI remains hospitalized for at least 5 days with parenteral antibiotics until the results of bacteriological culture If the bacteriological diagnosis is negative and the clinical suspicion of infection is weak treatment is stopped at least 7 days post-operatively If the microbiological diagnosis is positive the choice of the therapeutic will depend on the isolated bacterial species So microbiology remains essential and the delay of obtention of microbiological results is crucial to adapt the antibiotic treatment
Microbiological culture techniques remain the gold standard but are time-consuming 3 to 14 days and require qualified personnel with a risk of false negative results in 5 to 10 of cases prior antibiotic therapy atypical or fastidious microorganisms These diagnostic limitations lead to care difficulties with major consequences in terms of morbidity quality of life and treatment costs
Syndromic molecular methods metagenomics Unyvero Cartridges Biofire nested-PCR which could improve microbiological diagnosis are currently being evaluated but have a number of drawbacks that make this tests as complementary methods in specialized laboratories cost productivity insufficient panels etc
The DendrisCHIPOA platform has demonstrated its ability to offer routine molecular identification of the current micro-organisms involved in BJI in less than 5 hours with the detection of mecA resistance genes on series of 16 to 64 samples The DendrisCHIPOA is CE-marked and has already been the subject of an initial publication evaluating its performances in a single center
On the other hand the innovation brought by this technology is the analysis by artificial intelligence thanks to the DendriSOFT software which takes into account biological variability This database is constantly enhanced by self-learning
The research will be carried out over a 6-months period to include 100 patients in five inclusion centers CRIOAc in Ile de France region with a minimum of 2 patients treated for BJI per week per inclusion center
The main objective of this study is to evaluate the diagnostic performances of the DendrisCHIPOA in detecting the pathogens recognized in its panel and the detection of the mecA gene compared with the routine microbiological techniques used in the inclusion centers participating to the study
The secondary objectives are
to document discrepancies using alternative techniques specific PCR sequencing
to compare turnaround times from sampling to biological validation between the routine microbiological technique and DendrisCHIPOA
to evaluate the impact on the patients therapeutic management modification of antibiotic treatment
to evaluate diagnostic performance of the DendrisCHIPOA on a sub-group of culture-negative patients with clinical signs of infection
In case of BJI with material the diagnosis is based on a set of clinical bacteriological cytological and radiological criteria known as the EBJIS 2021 European Bone Joint Infections Society criteria For septic arthritis diagnosis is based on bacteriology and cytology
Currently a patient with suspected BJI remains hospitalized for at least 5 days with parenteral antibiotics until the results of bacteriological culture If the bacteriological diagnosis is negative and the clinical suspicion of infection is weak treatment is stopped at least 7 days post-operatively If the microbiological diagnosis is positive the choice of the therapeutic will depend on the isolated bacterial species So microbiology remains essential and the delay of obtention of microbiological results is crucial to adapt the antibiotic treatment
Microbiological culture techniques remain the gold standard but are time-consuming 3 to 14 days and require qualified personnel with a risk of false negative results in 5 to 10 of cases prior antibiotic therapy atypical or fastidious microorganisms These diagnostic limitations lead to care difficulties with major consequences in terms of morbidity quality of life and treatment costs
Syndromic molecular methods metagenomics Unyvero Cartridges Biofire nested-PCR which could improve microbiological diagnosis are currently being evaluated but have a number of drawbacks that make this tests as complementary methods in specialized laboratories cost productivity insufficient panels etc
The DendrisCHIPOA platform has demonstrated its ability to offer routine molecular identification of the current micro-organisms involved in BJI in less than 5 hours with the detection of mecA resistance genes on series of 16 to 64 samples The DendrisCHIPOA is CE-marked and has already been the subject of an initial publication evaluating its performances in a single center
On the other hand the innovation brought by this technology is the analysis by artificial intelligence thanks to the DendriSOFT software which takes into account biological variability This database is constantly enhanced by self-learning
The research will be carried out over a 6-months period to include 100 patients in five inclusion centers CRIOAc in Ile de France region with a minimum of 2 patients treated for BJI per week per inclusion center
The main objective of this study is to evaluate the diagnostic performances of the DendrisCHIPOA in detecting the pathogens recognized in its panel and the detection of the mecA gene compared with the routine microbiological techniques used in the inclusion centers participating to the study
The secondary objectives are
to document discrepancies using alternative techniques specific PCR sequencing
to compare turnaround times from sampling to biological validation between the routine microbiological technique and DendrisCHIPOA
to evaluate the impact on the patients therapeutic management modification of antibiotic treatment
to evaluate diagnostic performance of the DendrisCHIPOA on a sub-group of culture-negative patients with clinical signs of infection
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