Investigation of an Outbreak Situation of Cutaneous Leishmaniasis Among Military Personnel in French Guiana (CEFELEISH)

NCT04888130 | Completed

• 1 other identifier: CEFELEISH
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical, epidemiological, therapeutic and microbiological investigation of an outbreak of cutaneous Leishmaniasis that occurred among military personnel in French Guiana in 2020.

Conditions

Leishmaniasis, Cutaneous

Keywords

Leishmaniasis, Cutaneous; Risk Factors; Phylogeny; Military Personnel; Prevalence; French Guiana; Outbreak

Outcome Measures

Primary Outcomes (1)

• Severity of leishmaniasis

  • For the cohort study part: Primary endpoint: severity of leishmaniasis (clinical presentation, cure after Pentacarinat) Associations will be sought between this main criterion and the phylogeny of the strains and the patient's intrinsic risk factors.

  5 months

Other Outcomes (1)

• Frequency of responses collected during questionnaire

  5 months

Study Arms (2)

Cases

This study comes following an outbreak signal that occurred in May 2020, after the detection of numerous cases of cutaneous leishmaniasis in military personnel probably contaminated during a training course (Training Center in the Equatorial Forest, CEFE) in the town of Regina. To date, around 40 cases have been detected.

Genetic: Phylogenetic Analysis; Other: Data collection

Controls

A case-control study can therefore be carried out using a questionnaire offered to all course participants over the 1st semester of 2020. The controls will then be participants who have not been infected. A comparison can also be made between the military personnel present in French Guiana during the first half of 2020 and having carried out missions in the forest, by opposing the participants and non-participants of the CEFE.

Other: Data collection

Interventions

Phylogenetic Analysis GENETIC

The phylogenetic analysis is carried out on a sample already taken in routine care (smear, culture on biopsy or PCR on swab).

Cases

Data collection OTHER

Data will be collected using a standardized digital questionnaire, including clinical and microbiological features, treatments received details and training conditions and. Data will then be compared between patients with therapeutic success or failure.

Cases; Controls

Eligibility Criteria

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

Study Population

This study comes following an outbreak signal that occurred in May 2020, after the detection of numerous cases of cutaneous leishmaniasis in military personnel probably contaminated during a training course (Training Center in the Equatorial Forest, CEFE) in the town of Regina. To date, around 40 cases have been detected. A case-control study can therefore be carried out using a questionnaire offered to all course participants over the 1st semester of 2020. The controls will then be participants who have not been infected. A comparison can also be made between the military personnel present in French Guiana during the first half of 2020 and having carried out missions in the forest, by opposing the participants and non-participants of the CEFE.

You may qualify if:

• \* for cases :
• Confirmed cutaneous leishmaniasis (compatible clinical lesion + a positive microbiological test or cure after probabilistic anti-leishmania treatment) in a military personnel who participated in the CEFE training
• \*for controls :
• Absence of a suspicious lesion of leishmaniasis in a military personnel who participated in training at CEFE
• NB: All concerned are adults.
• \*for cases :
• Confirmed cutaneous leishmaniasis not having been contracted after a training at CEFE
• Unconfirmed cutaneous leishmaniasis
• Opposition to the use of their data and / or the completion of the questionnaire
• Refusal of participation
• \*for controls :
• Opposition to the taking of the questionnaire
• Refusal of participation training

Sponsors & Collaborators

• Centre Hospitalier de Cayenne: lead
• Centre Médical Inter-Armées (CMIA) de Cayenne, French Guiana: collaborator
• Centre Médical Inter-Armées (CMIA) de Kourou, French Guiana: collaborator
• Direction Interarmées du Service de Santé des Armées (DIASS) de Cayenne, French Guiana: collaborator
• Centre National de Référence des Leishmanioses, CHU de Montpellier, France: collaborator

Study Sites (1)

General Hospital of Cayenne

Cayenne, 97306, French Guiana

Location

Related Publications (3)

• Loiseau R, Nabet C, Simon S, Ginouves M, Brousse P, Blanchet D, Demar M, Couppie P, Blaizot R. American cutaneous leishmaniasis in French Guiana: an epidemiological update and study of environmental risk factors. Int J Dermatol. 2019 Nov;58(11):1323-1328. doi: 10.1111/ijd.14625. Epub 2019 Sep 16.

  PMID: 31524286 BACKGROUND

• Simon S, Nacher M, Carme B, Basurko C, Roger A, Adenis A, Ginouves M, Demar M, Couppie P. Cutaneous leishmaniasis in French Guiana: revising epidemiology with PCR-RFLP. Trop Med Health. 2017 Feb 28;45:5. doi: 10.1186/s41182-017-0045-x. eCollection 2017.

  PMID: 28265182 BACKGROUND

• Martin-Blondel G, Iriart X, El Baidouri F, Simon S, Mills D, Demar M, Pistone T, Le Taillandier T, Malvy D, Gangneux JP, Couppie P, Munckhof W, Marchou B, Ravel C, Berry A. Outbreak of Leishmania braziliensis Cutaneous Leishmaniasis, Saul, French Guiana. Emerg Infect Dis. 2015 May;21(5):892-4. doi: 10.3201/eid2105.141181. No abstract available.

  PMID: 25897573 BACKGROUND

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Phylogeny; Data Collection

Condition Hierarchy (Ancestors)

Leishmaniasis; 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)

Biological Evolution; Genetic Phenomena; Biological Phenomena; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• DEMAR PIERRE Magalie, PhD

  Centre Hospitalier de Cayenne

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: December 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: May 7, 2021
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

FR (1)