Mediterranean Visceral Leishmaniasis With Leishmania Infantum (AsymptoGen)

February 2, 2024 updated by: Centre Hospitalier Universitaire de Nice

Mediterranean Visceral Leishmaniasis With Leishmania Infantum: Genetic Characterization of the Host Parasite in Relation to Asymptomatic Human Carriage

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Recruiting
        • Nice hospital
        • Contact:
        • Principal Investigator:
          • Christelle POMARES, MCUPH
        • Sub-Investigator:
          • Gregory MICHEL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • criteria for EFS blood donation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
asymptomatic carrier
Other: blood donation and isolation of leuco-platelet layers
patients donating blood. Blood bags will be treated and leuco-platelet coatings will be sent to Nice
uninfected subjects
Other: blood donation and isolation of leuco-platelet layers
patients donating blood. Blood bags will be treated and leuco-platelet coatings will be sent to Nice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
genetic level characterization of the isolates of L. infantum
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2019

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

August 15, 2024

Study Registration Dates

First Submitted

November 20, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 21, 2018

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-API-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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