Hansen's DiseaseEPI-LEPRNCT05031091
Epidemiology of Leprosy in French Guiana
An observational study of Hansen's Disease, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hansen's Disease
- What is being tested?
- standardised exposure questionnaire
- How many people
- 368 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 7 Jan 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- FOR TRANSVERSAL STUDY:
- Opposition to participation
- Diagnosis of leprosy invalidated after inclusion
- FOR CASE-CONTROL STUDY - CASES:
- Opposition to participation
- Inability to answer to the questionnaire
Show all 10Show fewer
- Diagnosis of leprosy invalidated after inclusion
- FOR CASE-CONTROL STUDY - CONTROL:
- Opposition to participation
- Inability to answer to the questionnaire
Trial locations and contacts
1 site in 1 country.
French Guiana1 site, 1 recruiting
- Recruiting
General Hospital of Cayenne
Cayenne, 97306
Mathieu Nacher, Pr, 0594395385, mathieu.nacher@ch-cayenne.fr
Roxane Schaubb, PhD, 05 94 39 53 88, roxane.schaub@ch-cayenne.fr
About this study
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.
Read the detailed description
Rationale: Leprosy (also known as Hansen's disease) is a chronic infection caused by intracellular mycobacteria, Mycobacterium leprae and Mycobacterium lepromatosis (discovered in 2008), preferentially affecting the skin and peripheral nervous system. The disease in humans is potentially disabling and stigmatising.
The modes of transmission of leprosy are not yet fully understood, although it is generally accepted that the main mode of transmission is human-to-human. Apart from humans, the only other major confirmed animal reservoir of M. leprae is the 9-banded armadillo Dasypus novemcinctus, which is found only in the Americas. Recent studies in the southern United States suggest transmission of M. leprae between D. novemcinctus and humans, where 64% of human cases may be attributable to armadillos. Uncertainties remain regarding the zoonotic nature of the disease outside the US and the precise mode of transmission.
The disease is endemic on the American continent where 92% of new cases come from Brazil. In French Guiana - bordering Brazil - leprosy is still present and shows a tendency to recrudesce with about 10 new cases per year. Armadillo consumption is frequent.
Objectives: 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 Population and methods: A cross-sectional study will be conducted on approximately 150 cases of leprosy diagnosed between 2006 and 2022 in French Guyana, seen by the department's anti-leprosy service and for which a skin biopsy (or dermal smear or nasal swab) is available. Genotyping of M. leprae and the search for antibiotic resistance, as well as the search for M. lepromatosis will be carried out by molecular biology. Human strains will be compared with environmental strains from French Guiana and with reference strains found in humans and armadillos. A minimum-spanning-tree and maximum parsimony analysis will be performed to determine the phylogenetic relationships between the different strains.
A 3:1 matched case-control study will be conducted to assess risk factors for leprosy in French Guiana. The 92 cases will be recruited from among leprosy cases diagnosed between 2006 and 2022 in French Guyana, seen by the departmental leprosy control. The 276 controls will be recruited by dermatologists from the Cayenne hospital, throughout the territory, by matching 3 controls per case according to sex and age (± 5 years). A standardised exposure questionnaire will be conducted face to face or by telephone. The search for leprosy risk factors and in particular direct or indirect contact with armadillos (proximity / hunting / handling / consumption) will be explored by univariate and then multivariate conditional logistic regressions taking into account known potential confounding factors.
- Conditions
- Hansen's Disease
- Being tested
- standardised exposure questionnaire
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardised exposure questionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| Case: patients with confirmed leprosy | diagnosed or followed up in French Guiana between the beginning of 2006 and the end of 2022 Receives: 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 Receives: Other: standardised exposure questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (5)
Phylogenetic relationships between strains
Determination of phylogenetic relationships between strains by relative proximity of strains
Measured: 1 day
M. lepromatosis positivity determined by qPCR (real-time PCR)
- lepromatosis positivity determined by qPCR (real-time PCR)
Measured: 1 day
presence of antibiotic resistance mutation
Presence of antibiotic resistance mutations (primary resistance in samples from new leprosy cases, secondary resistance in samples from retreatment cases (patient diagnosed with leprosy who has already received treatment for leprosy), by PCR or whole genome sequencing
Measured: 1 day
identification of direct contact (hunting/handling/consumption) with armadillos and other wild animals
identification of risk factors for leprosy in humans in French Guiana: Description of the sociodemographic and clinical characteristics of patients
Measured: 1 day
identification of indirect contact (proximity/work on the land) with armadillos and other wild animals
identification of risk factors for leprosy in humans in French Guiana: Description of the sociodemographic and clinical characteristics of patients
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start7 Jan 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hansen's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031091
- Sponsor's protocol ID
- EPI-LEPR
- Acronym
- EPI-LEPR
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Leprosy in French Guiana
- ClinicalTrials.gov ID
- NCT05031091
- Acronym / sponsor ID
- EPI-LEPR / EPI-LEPR
- Conditions
- Hansen's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Leprosy (also known as Hansen's disease) is a chronic infection caused by intracellular mycobacteria, Mycobacterium leprae and Mycobacterium lepromatosis (discovered in 2008), preferentially affecting the skin and peripheral nervous system. The disease in humans is potentially disabling and stigmatising.
The modes of transmission of leprosy are not yet fully understood, although it is generally accepted that the main mode of transmission is human-to-human. Apart from humans, the only other major confirmed animal reservoir of M. leprae is the 9-banded armadillo Dasypus novemcinctus, which is found only in the Americas. Recent studies in the southern United States suggest transmission of M. leprae between D. novemcinctus and humans, where 64% of human cases may be attributable to armadillos. Uncertainties remain regarding the zoonotic nature of the disease outside the US and the precise mode of transmission.
The disease is endemic on the American continent where 92% of new cases come from Brazil. In French Guiana - bordering Brazil - leprosy is still present and shows a tendency to recrudesce with about 10 new cases per year. Armadillo consumption is frequent.
Objectives: 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 Population and methods: A cross-sectional study will be conducted on approximately 150 cases of leprosy diagnosed between 2006 and 2022 in French Guyana, seen by the department's anti-leprosy service and for which a skin biopsy (or dermal smear or nasal swab) is available. Genotyping of M. leprae and the search for antibiotic resistance, as well as the search for M. lepromatosis will be carried out by molecular biology. Human strains will be compared with environmental strains from French Guiana and with reference strains found in humans and armadillos. A minimum-spanning-tree and maximum parsimony analysis will be performed to determine the phylogenetic relationships between the different strains.
A 3:1 matched case-control study will be conducted to assess risk factors for leprosy in French Guiana. The 92 cases will be recruited from among leprosy cases diagnosed between 2006 and 2022 in French Guyana, seen by the departmental leprosy control. The 276 controls will be recruited by dermatologists from the Cayenne hospital, throughout the territory, by matching 3 controls per case according to sex and age (± 5 years). A standardised exposure questionnaire will be conducted face to face or by telephone. The search for leprosy risk factors and in particular direct or indirect contact with armadillos (proximity / hunting / handling / consumption) will be explored by univariate and then multivariate conditional logistic regressions taking into account known potential confounding factors.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case: patients with confirmed leprosy | – | Other: standardised exposure questionnairediagnosed or followed up in French Guiana between the beginning of 2006 and the end of 2022 |
| Control: patient with a dermatological condition not clinically suspicious of leprosy | – | Other: standardised exposure questionnaireAny 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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)
- 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
Key exclusion criteria (10 listed)
- Opposition to participation
- Diagnosis of leprosy invalidated after inclusion
- Opposition to participation
- Inability to answer to the questionnaire
- Diagnosis of leprosy invalidated after inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardised exposure questionnaireA 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 | Other | Case: patients with confirmed leprosy, Control: patient with a dermatological condition not clinically suspicious of leprosy |
Primary outcome
Genotype of M. Leprae srtrains
Time frame: 1 day
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.
5 secondary outcomes
Phylogenetic relationships between strains
Time frame: 1 day
M. lepromatosis positivity determined by qPCR (real-time PCR)
Time frame: 1 day
presence of antibiotic resistance mutation
Time frame: 1 day
identification of direct contact (hunting/handling/consumption) with armadillos and other wild animals
Time frame: 1 day
identification of indirect contact (proximity/work on the land) with armadillos and other wild animals
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hansen's Disease, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in French Guiana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotype of M. Leprae srtrains (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.