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.
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.
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)
- Conditions
- Leishmaniasis, Cutaneous
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted17 May 2021
- Study start1 Dec 2020
- Primary completion1 Mar 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Leishmaniasis, CutaneousStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Médical Inter-Armées (CMIA) de Cayenne, French Guiana, Centre Médical Inter-Armées (CMIA) de Kourou, French Guiana, Direction Interarmées du Service de Santé des Armées (DIASS) de Cayenne, French Guiana, Centre National de Référence des Leishmanioses, CHU de Montpellier, France
- Responsible party
- Sponsor
- Investigators
- DEMAR PIERRE Magalie, PhD, Study director, Centre Hospitalier de Cayenne
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 31524286Simon 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 28265182Martin-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
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of an Outbreak Situation of Cutaneous Leishmaniasis Among Military Personnel in French Guiana (CEFELEISH)
- ClinicalTrials.gov ID
- NCT04888130
- Acronym / sponsor ID
- CEFELEISH / CEFELEISH
- Conditions
- Leishmaniasis, Cutaneous
- Keywords
- Leishmaniasis, Cutaneous, Risk Factors, Phylogeny, Military Personnel, Prevalence, French Guiana, Outbreak
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Collaborators
- Centre Médical Inter-Armées (CMIA) de Cayenne, French Guiana, Centre Médical Inter-Armées (CMIA) de Kourou, French Guiana, Direction Interarmées du Service de Santé des Armées (DIASS) de Cayenne, French Guiana, Centre National de Référence des Leishmanioses, CHU de Montpellier, France
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 17 May 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.
Clinical, epidemiological, therapeutic and microbiological investigation of an outbreak of cutaneous Leishmaniasis that occurred among military personnel in French Guiana in 2020.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Genetic: Phylogenetic Analysis, Other: Data collectionThis 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. |
| Controls | – | Other: Data collectionA 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 qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (14 listed)
- 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
- 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
- Confirmed cutaneous leishmaniasis not having been contracted after a training at CEFE
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Phylogenetic AnalysisThe phylogenetic analysis is carried out on a sample already taken in routine care (smear, culture on biopsy or PCR on swab). | Genetic | Cases |
| Data collectionData 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. | Other | Cases, Controls |
Primary outcome
Severity of leishmaniasis
Time frame: 5 months
• 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Background: PubMed 31524286Loiseau 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.
- Background: PubMed 28265182Simon 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.
- Background: PubMed 25897573Martin-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.
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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.
DEMAR PIERRE Magalie, PhD study director
Centre Hospitalier de Cayenne
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 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.