Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431958
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-22
Brief Title:
Droplet Digital PCR and PCR-free BIOSensors for the Detection of Resistance-associated SNPs in Pneumocystis Jirovecii
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Droplet Digital PCR and PCR-free BIOSensors for the Detection of Resistance-associated SNPs in Pneumocystis Jirovecii
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
DDBIOS
Brief Summary:
The main objective of the proposed research is to identify Pneumocystis jirovecii mutant strains on 4 genes encoding therapeutic targets such as dihydropteroate synthase DHPS dihydrofolate reductase DHFR cytochrome b CYB inosine-5-monophosphate dehydrogenase IMPDH and therefore to assess the prevalence of potentially resistant strains in patients infected with P jirovecii
Detailed Description:
Pneumocystis jirovecii P jirovecii is an opportunistic pathogenic fungus responsible for pulmonary infection or Pneumocystis pneumonia PCP in immunocompromised patients There is currently no system for its in vitro culture The diagnostic methods used are mainly based on molecular biology techniques which also allow the detection and analysis of single nucleotide polymorphisms SNPs particularly at the level of genes coding for the targets of molecules widely used in the prevention and treatment of PCP These SNPs may represent missense mutations potentially associated with treatment resistance They may result from exposure of patients to these treatments before the development of P jirovecii infection However data concerning the prevalence of these mutations remains scarce particularly in France Methods for detecting these mutations based on PCR followed by DNA sequencing have limitations in terms of sensitivity The evaluation of new more sensitive and rapid tools for the detection and characterization of pathogens in this context is necessary
The main objective of the proposed research is to identify P jirovecii mutant strains on 4 genes encoding therapeutic targets such as dihydropteroate synthase DHPS dihydrofolate reductase DHFR cytochrome b CYB inosine-5-monophosphate dehydrogenase IMPDH and therefore to assess the prevalence of potentially resistant strains in patients infected with P jirovecii
The secondary objectives are
to determine the factors associated eg exposure to treatments with mutant P jirovecii strains
to determine the impact of mutations on the effectiveness of anti-Pneumocystis treatment eg favorable vs unfavorable evolution of the infection
to evaluate two methods - digital droplet PCR and biosensors without PCR - for the detection and characterization of mutations associated with resistance in Pneumocystis jirovecii
The main objective of the proposed research is to identify P jirovecii mutant strains on 4 genes encoding therapeutic targets such as dihydropteroate synthase DHPS dihydrofolate reductase DHFR cytochrome b CYB inosine-5-monophosphate dehydrogenase IMPDH and therefore to assess the prevalence of potentially resistant strains in patients infected with P jirovecii
The secondary objectives are
to determine the factors associated eg exposure to treatments with mutant P jirovecii strains
to determine the impact of mutations on the effectiveness of anti-Pneumocystis treatment eg favorable vs unfavorable evolution of the infection
to evaluate two methods - digital droplet PCR and biosensors without PCR - for the detection and characterization of mutations associated with resistance in Pneumocystis jirovecii
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