CompletedNot Applicable

Spatial Analysis of Host-parasite Interactions in Cutaneous Leishmaniasis in Ethiopia

Ethiopia92 participantsStarted 2022-03-21

Plain-language summary

Cutaneous leishmaniasis manifestations range from self-healing localized skin ulcers/nodules to diffusely spread chronic lesions. Knowledge on the host-parasite interactions underpinning the different clinical presentations is scarce, in particular for L. aethiopica infections where disease can be extremely severe. Our aim is to define differences in skin immune responses and parasite virulence in CL patients at single cell/parasite level and how it underpins the different clinical presentations (localised, mucocutaneous and diffuse), by producing the first spatially-resolved 'ecological' map of the lesions.

Who can participate

Age range12 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Willing and able to provide informed consent * Clinically confirmed CL diagnosis * Between 12 and 50 years of age Exclusion Criteria: * Difficult or too painful sampling zone (see skin biopsy procedure below) * (Primary) lesion size \< 1 cm * Already receiving CL treatment or received CL treatment in the last 3 months (excluding traditional medicine) * Known major comorbidity at time of diagnosis (e.g. VL, HIV, TB, malaria, severe intestinal helminth infection) * Medical history of VL * Severely underweight (BMI\<16) * Known pregnancy * Use of immunosuppressive medication in the last month * Known excessive alcohol use (between \>10 intakes/day and \>10 intakes/week) * History of hypersensitivity to local anaesthetics * Presence of keloids/hypertrophic scars

What they're measuring

Spatially resolved immunological characterization of the CL lesion using single cell RNA sequencing and digital spatial profiling

Timeframe: Day 0

Genomic characterization of L. aethiopica using whole genome sequencing

Timeframe: Day 0

Defining microenvironment and parasite niches in CL lesions using digital spatial profiling

Timeframe: Day 0

Spatially resolved determination of the metabolic profile of the CL lesion using spatial OMx

Timeframe: Day 0

The association between host/parasite factors and patients after treatment using clinical parameters

Timeframe: Month 6

Trial details

NCT IDNCT05332093

SponsorInstitute of Tropical Medicine, Belgium

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03-30

View on ClinicalTrials.gov More Cutaneous Leishmaniases trials

Plain-language summary

Who can participate

Age range12 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Spatially resolved immunological characterization of the CL lesion using single cell RNA sequencing and digital spatial profiling

Timeframe: Day 0

Genomic characterization of L. aethiopica using whole genome sequencing

Timeframe: Day 0

Defining microenvironment and parasite niches in CL lesions using digital spatial profiling

Timeframe: Day 0

Spatially resolved determination of the metabolic profile of the CL lesion using spatial OMx

Timeframe: Day 0

The association between host/parasite factors and patients after treatment using clinical parameters

Timeframe: Month 6