Mediterranean Visceral Leishmaniasis With Leishmania Infantum

NCT03784248 | Active Not Recruiting

• 1 other identifier: 17-API-02
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Leishmaniasis

Outcome Measures

Primary Outcomes (1)

• genetic level characterization of the isolates of L. infantum

  To characterize at the genetic level the isolates of L. infantum present in asymptomatic carriers in South-East and South-West France, it will be studied12 microsatellite loci by PCR - laboratory tests

  6 months

Study Arms (2)

asymptomatic carrier

Other: blood donation and isolation of leuco-platelet layers

uninfected subjects

Other: blood donation and isolation of leuco-platelet layers

Interventions

blood donation and isolation of leuco-platelet layers OTHER

patients donating blood. Blood bags will be treated and leuco-platelet coatings will be sent to Nice

asymptomatic carrier; uninfected subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Anyone aged 18 to 70, who weighs more than 50 kg and is recognized as fit following the predon interview, can donate blood. Men can give up to 6 times a year and women up to 4 times. Between two blood donations, a minimum of 8 weeks must be respected.

You may qualify if:

• Meet EFS blood donation criteria
• Provenance:
• Department of Alpes-Maritimes, Var and Bouches du Rhône, for the historical endemic outbreak Department of Gers, Tarn-et-Garonne and Lot for the new Occitanie household
• \- Donor who has signed genetic consent

You may not qualify if:

• criteria for EFS blood donation

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Leishmaniasis

Interventions

Blood Donation

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tissue and Organ Procurement; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: December 21, 2018
• Study Start: July 3, 2019
• Primary Completion: July 15, 2025
• Study Completion: August 15, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

FR (1)