Ignite Creation Date:
2024-05-06 @ 12:31 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03784248
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2018-11-20
Brief Title:
Mediterranean Visceral Leishmaniasis With Leishmania Infantum
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Mediterranean Visceral Leishmaniasis With Leishmania Infantum Genetic Characterization of the Host Parasite in Relation to Asymptomatic Human Carriage
Status:
RECRUITING
Status Verified Date:
2024-02
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:
AsymptoGen
Brief Summary:
L infantum leishmaniasis is endemic in the South of France For several years there has been an expansion of the territory of sandflies vector of leishmaniasis with the appearance of cases of canine leishmaniasis in new outbreaks West of the Occitania region South-West The transition from asymptomatic to disease depends largely on the immune status of the carrier but many other factors specific to the parasite and host remain poorly defined Asymptomatic carriage is present in a large majority of infected subjects however to date only parasite isolates causing the patent form have been characterized
In this PHRC the team wishes to study the genetics of parasite isolates present in asymptomatic carriers of the Alpes-Maritimes outbreak and the new Occitanie outbreak as well as the genetics of the host
The primary objective is the genetic characterization of L infantum isolates by the microsatellite method present in asymptomatic carriers in southeast and southwestern France
The secondary objectives are
1 Comparison of the genetic profiles of L infantum isolates by microsatellite method from asymptomatic carriers of the new Southwestern outbreak with isolates from asymptomatic carriers of the historical Southwestern outbreak
2 Comparison of the genetic profiles of L infantum isolates by the microsatellite method present in asymptomatic carriers in the Southeast with the profiles of isolates present in patients in the same outbreak for whom a microsatellite study has already been obtained previously
3 the team is also conducting a preliminary study of the host genetic factors that would be associated with asymptomatic carriage by studying the association between potential host-related genetic risk factors HLA typing NLRP3 gene study and asymptomatic carriage Indeed a recent study showed that the NLRP3 gene prevents the development of the patent form of leishmaniasis in the mouse model This preliminary genetic study will identify potential host-related factors associated with asymptomatic carriage
To meet these objectives leuco-platelet layer parasites CLP obtained via EFS from the 2 sources of interest will be isolated
This project is a research not involving the human person It is multicentric and non-randomized
As a result of this research isolates from asymptomatic carriers of the historical outbreak will be studied and compared to those present in new endemic outbreaks as well as to those of patients already studied in a previous study A better knowledge of parasites circulating in asymptomatic carriers will make it possible to study in a comprehensive way the risk factors associated with the parasite In addition the study of asymptomatic carrying in new endemic outbreaks such as Occitania is very original since no human studies have yet been undertaken in this region The results obtained in this PHRC will be used to understand the factors associated with the development of visceral leishmaniasis
In this PHRC the team wishes to study the genetics of parasite isolates present in asymptomatic carriers of the Alpes-Maritimes outbreak and the new Occitanie outbreak as well as the genetics of the host
The primary objective is the genetic characterization of L infantum isolates by the microsatellite method present in asymptomatic carriers in southeast and southwestern France
The secondary objectives are
1 Comparison of the genetic profiles of L infantum isolates by microsatellite method from asymptomatic carriers of the new Southwestern outbreak with isolates from asymptomatic carriers of the historical Southwestern outbreak
2 Comparison of the genetic profiles of L infantum isolates by the microsatellite method present in asymptomatic carriers in the Southeast with the profiles of isolates present in patients in the same outbreak for whom a microsatellite study has already been obtained previously
3 the team is also conducting a preliminary study of the host genetic factors that would be associated with asymptomatic carriage by studying the association between potential host-related genetic risk factors HLA typing NLRP3 gene study and asymptomatic carriage Indeed a recent study showed that the NLRP3 gene prevents the development of the patent form of leishmaniasis in the mouse model This preliminary genetic study will identify potential host-related factors associated with asymptomatic carriage
To meet these objectives leuco-platelet layer parasites CLP obtained via EFS from the 2 sources of interest will be isolated
This project is a research not involving the human person It is multicentric and non-randomized
As a result of this research isolates from asymptomatic carriers of the historical outbreak will be studied and compared to those present in new endemic outbreaks as well as to those of patients already studied in a previous study A better knowledge of parasites circulating in asymptomatic carriers will make it possible to study in a comprehensive way the risk factors associated with the parasite In addition the study of asymptomatic carrying in new endemic outbreaks such as Occitania is very original since no human studies have yet been undertaken in this region The results obtained in this PHRC will be used to understand the factors associated with the development of visceral leishmaniasis
Detailed Description:
None
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