Epidemiology of Leprosy in French Guiana

NCT05031091 | Unknown

• 1 other identifier: EPI-LEPR
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the present study is the genotyping of M. leprae strains found in leprosy patients in French Guiana. The secondary objectives are to investigate the presence of M. lepromatosis in these patients, the molecular research of M. leprae resistance to anti-leprosy antibiotics, the study of risk factors for leprosy in humans in Guyana and in particular direct or indirect contact with armadillos, as well as the determination of phylogenetic links between the M. leprae strains found in French Guiana, and with the regional and world reference strains Epidemiology of leprosy in French Guiana.

Conditions

Hansen's Disease

Outcome Measures

Primary Outcomes (1)

• Genotype of M. Leprae srtrains

  Genotyping of M. leprae strains will be genotyped by determining the type (1,2,3,4), subtype (A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P) by SNP (Single Nucleotide Polymorphism) sequencing and VNTR (Variable Number Tandem Repeat) typing of each selected strain, as recommended by Singh and Cole and used by Truman and Sharma , or, depending on the bacterial index and technical possibilities, by whole genome sequencing, as described by Stefani.

  1 day

Secondary Outcomes (5)

• Phylogenetic relationships between strains

  1 day

• M. lepromatosis positivity determined by qPCR (real-time PCR)

  1 day

• presence of antibiotic resistance mutation

  1 day

• identification of direct contact (hunting/handling/consumption) with armadillos and other wild animals

  1 day

• identification of indirect contact (proximity/work on the land) with armadillos and other wild animals

  1 day

Study Arms (2)

Case: patients with confirmed leprosy

diagnosed or followed up in French Guiana between the beginning of 2006 and the end of 2022

Other: standardised exposure questionnaire

Control: patient with a dermatological condition not clinically suspicious of leprosy

Any patient, of any age, consulting for a dermatological pathology not clinically suspicious of leprosy during a dermatological consultation by a practitioner of the Cayenne Hospital

Other: standardised exposure questionnaire

Interventions

standardised exposure questionnaire OTHER

A standardised exposure questionnaire will be conducted face to face or by telephone. The search for risk factors for leprosy and in particular direct or indirect contact with armadillos will be explored

Case: patients with confirmed leprosy; Control: patient with a dermatological condition not clinically suspicious of leprosy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For cases: The source population is that of patients with confirmed leprosy, diagnosed or followed up in French Guiana between the beginning of 2006 and the end of 2022, seen in dermatology consultations as part of the Hansen's disease control programme in French Guiana or seen in infectious diseases consultations. For controls:The target population for the controls is that of patients with another dermatological pathology in French Guiana. The source population is that of patients seen in consultation by the team of the dermatology department of the Cayenne Hospital for any other reason than leprosy, seen at the Cayenne Hospital or during dermatology consultations carried out in the health centres or at the CHOG.

You may qualify if:

• FOR TRANSVERSAL STUDY:
• any patient, regardless of age, consulting a practitioner at the Cayenne Hospital with a clinical suspicion of leprosy
• Diagnosis of leprosy, confirmed histologically or bacteriologically, made in Guyana between 2006 and 2022
• Skin biopsy (or dermal smear or nasal swab) available in the anatomopathology department of the Andrée Rosemon Hospital and analysable (correct state of preservation and sufficient quantity of tissue)
• FOR CASE-CONTROL STUDY - CASES:
• any patient, regardless of age, consulting a practitioner at the Cayenne Hospital with a clinical suspicion of leprosy
• Diagnosis of leprosy, confirmed histologically or bacteriologically, made in Guyana between 2006 and 2022
• FOR CASE-CONTROL STUDY - CONTROL:
• Any patient, of any age, consulting for a dermatological pathology not clinically suspicious of leprosy during a dermatological consultation by a practitioner of the Cayenne Hospital

You may not qualify if:

• FOR TRANSVERSAL STUDY:
• Opposition to participation
• FOR CASE-CONTROL STUDY - CASES:
• Opposition to participation
• Inability to answer to the questionnaire
• FOR CASE-CONTROL STUDY - CONTROL:
• Opposition to participation
• Inability to answer to the questionnaire

Sponsors & Collaborators

• Centre Hospitalier de Cayenne: lead

Study Sites (1)

General Hospital of Cayenne

Cayenne, 97306, French Guiana

RECRUITING

MeSH Terms

Conditions

Leprosy

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 1, 2021
• Study Start: January 7, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)