Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04535505
Status:
WITHDRAWN
Last Update Posted:
2022-09-14
First Post:
2020-08-28
Brief Title:
Pathogenic Bordetella Rapid Detection
Sponsor:
Childrens Hospital of Fudan University
Organization:
Childrens Hospital of Fudan University
Study Overview
Official Title:
Establishment a Nucleic Acid Rapid Detection Technology Platform for Detecting Pathogenic Bordetella and Its Drug Resistance Genes
Status:
WITHDRAWN
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not as a lead unit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A CPA platform based on the CRISPR technology is going to established to achieve the goal of detecting pathogenic bordetella and drug resistance genes in one step The accuracy of this platform will be checked through prospective diagnostic test evaluation methods Bordetella pertussis isolation culture and identification would be set as a gold standard method
Detailed Description:
Pertussis is an acute respiratory infectious disease caused by bordetella pertussis Although it is a vaccine-preventable disease outbreaks and epidemic cases of whooping cough worldwide have been reported from time to time Bordella parapertussis Bodella bronchiseptica and bordetella hosei can cause pertussis-like diseases with symptoms similar to those of whooping cough The clinical manifestations are difficult to distinguish and they are easily reported as cases of whooping cough through the infectious disease network
The diagnosis of the infectious diseases caused by the four pathogenic bodella mainly relies on laboratory pathogenic testing At present the laboratory tests of bordetella that can be carried out in the clinical microbiology laboratory include culture bordetella pertussis specific antibody PT-IgG serological detection and bordetella pertussis nucleic acid PCR detection However none of them meet the requirements of early diagnosis
Cross primer constant temperature amplification CPA is nucleic acid constant temperature amplification technology with independent property rights The fully automated nucleic acid detection platform equipped with CPA technology would make the detection of four pathogenic bordetella easy quick and safe and accurate
As pathogenic bodella is difficult to cultivate and there is no standard for drug susceptibility test Studies have shown that 574 of the isolated clinical isolates of bordetella pertussis have MIC value for erthomycin 256 μgmL and 23s rRNA 2047 site adenine A were mutated to guanine GCRISPRCas is an immune system in bacteria that can specifically recognize invading nucleic acids and shear them The CRISPR technology developed based on the CRISPRCas principle can detect single point mutations in genes
The hypothesis that 4 pathogenic bordetella and their erythromycin resistance would be detected in one testing platform simultaneously The accuracy reliability predictive value of this platform would be checked through prospective diagnostic test evaluation methods Bordetella pertussis isolation culture and identification would be as the gold standard method
The diagnosis of the infectious diseases caused by the four pathogenic bodella mainly relies on laboratory pathogenic testing At present the laboratory tests of bordetella that can be carried out in the clinical microbiology laboratory include culture bordetella pertussis specific antibody PT-IgG serological detection and bordetella pertussis nucleic acid PCR detection However none of them meet the requirements of early diagnosis
Cross primer constant temperature amplification CPA is nucleic acid constant temperature amplification technology with independent property rights The fully automated nucleic acid detection platform equipped with CPA technology would make the detection of four pathogenic bordetella easy quick and safe and accurate
As pathogenic bodella is difficult to cultivate and there is no standard for drug susceptibility test Studies have shown that 574 of the isolated clinical isolates of bordetella pertussis have MIC value for erthomycin 256 μgmL and 23s rRNA 2047 site adenine A were mutated to guanine GCRISPRCas is an immune system in bacteria that can specifically recognize invading nucleic acids and shear them The CRISPR technology developed based on the CRISPRCas principle can detect single point mutations in genes
The hypothesis that 4 pathogenic bordetella and their erythromycin resistance would be detected in one testing platform simultaneously The accuracy reliability predictive value of this platform would be checked through prospective diagnostic test evaluation methods Bordetella pertussis isolation culture and identification would be as the gold standard method
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