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Leishmaniasis, CutaneousCEFELEISHNCT04888130

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

An observational study of Leishmaniasis, Cutaneous, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Leishmaniasis, Cutaneous
What is being tested?
Phylogenetic Analysis and Data collection
How many people
44 participants
Where
1 siteFrench Guiana
Study dates
1 Dec 2020to 7 May 2021
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.
  • Non inclusion criteria
Show all 14Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

French Guiana1 site
  • General Hospital of Cayenne

    Cayenne, 97306

Other trials in French Guiana

About this study

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

Read the detailed description

Cutaneous leishmaniasis is endemic in French Guiana and represents 200 to 300 cases per year. Transmission occurs after a sandfly bite, mainly during the rainy season and over almost all of French Guiana. The incidence is, however, greater in forest areas, especially in recently cleared areas. Nevertheless, transmission remains continuous and outbreaks remain rare and little investigated. 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. This outbreak raises several scientific questions, on the microbiological, clinical and epidemiological level.

From a microbiological point of view, it is not certain whether the occurrence of a large number of cases in a given group over a short period can be attributed to a single leishmania clone or only reflect exposure to a large number of infected sandflies. An L. braziliensis outbreak has been described in naturalists on mission in the Saul region, but it is possible that several species are detected in a larger outbreak. The description of the activities at the origin of the contamination can influence the offending species insofar as the different sandfly species do not use the same reservoirs, are not found in the same ecosystems and do not carry the same species of leishmanias.

Clinically, in the case that many patients are infected after the bite of similar sandflies and under similar conditions, similar clinical manifestations could be expected. It would be interesting to look for variations in terms of the type, number, localization, severity of lesions, and especially of response to treatment, which would reflect the role of factors linked to the host and its immune response. A phylogenetic study would make it possible to compare the strains isolated during this outbreak with other Guyanese isolates from the 2020 rainy season in order to search for a genetic cluster. A comparison can also be made between the strains of the outbreak in order to find a correlation with the clinical severity of certain patients or resistance to first-line treatment (Pentacarinat).

Epidemiologically, the outbreak occurred at a training site already used in previous years, but without such numerous cases being reported. This site sits on 700 hectares of primary forest and has not recently undergone additional development or deforestation. The course of activities and the type of training carried out by the military has not changed this year. A change in environmental conditions and exposure to sandflies therefore does not seem to explain this increase in cases. A capture of sandflies, delayed in relation to the period of contamination, would not allow the question of environmental change to be answered.

On the other hand, looking for behavioral risk factors (clothing, night shower, role played in exercises, type of hammock used, etc.) could provide explanations for the occurrence of infections in some trainees and not in their classmates. 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, in order to determine whether this course represented an independent risk factor for leishmaniasis. This result would reflect a higher exposure than conventional operations against gold mining, for example.

Investigation of this outbreak would make it possible to take corrective actions in terms of prevention and public health. It would provide a better understanding of the pathophysiological mechanism of contamination (clonal or not) and the consequences in terms of infecting species, clinical severity and expected therapeutic response in the circumstances of grouped cases of cutaneous leishmaniasis.

Retrospective cohort study for the clinical and microbiological part (grouped cases of an outbreak) Case-control section with questionnaires assessing exposure to sandflies National multicenter sample Category 3 Non-Interventional Human Person Research (RIPH 3)

Being tested
Phylogenetic Analysis, Data collection
Keywords
Leishmaniasis, Cutaneous, Risk Factors, Phylogeny, Military Personnel, Prevalence, French Guiana, Outbreak
Medical subject headings
Leishmaniasis, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phylogenetic AnalysisGenetic

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

  • Data collectionOther

    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.

Study groups in NCT04888130
Study groupRoleWhat they receive
CasesThis 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.
Receives: Genetic: Phylogenetic Analysis; Other: Data collection
ControlsA 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.
Receives: Other: Data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2021
  2. Study start1 Dec 2020
  3. Primary completion1 Mar 2021
  4. Study completion7 May 2021

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04888130
Sponsor's protocol ID
CEFELEISH
Acronym
CEFELEISH
Status last verified
May 2021
First submitted
11 May 2021
Last updated
17 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31524286
  • 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.

    PubMed 28265182
  • 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.

    PubMed 25897573

Questions about this trial

What is this clinical trial studying?

An observational study of Leishmaniasis, Cutaneous, 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 14 inclusion and 0 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: finished, as of the sponsor's last update on 17 May 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of leishmaniasis (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04888130, which also lists 3 linked publications.

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 17 May 2021.

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