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NCT Number: NCT05332093

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

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.

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Key information

Conditions

Cutaneous Leishmaniases Disease Attributes Euglenozoa Infections Infections Leishmaniasis Leishmaniasis, Cutaneous Neglected Diseases Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

12 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Gondar

Gonder, Amhara, 6200, Ethiopia

About this study

Specific objectives:

  • To profile the full heterogeneity in skin and lesion immunity (single cell RNAseq), and the cellular microenvironment surrounding infected and non-infected macrophages (digital spatial profiling).
  • To study the genomic diversity of L. aethiopica and identify features associated with the different clinical presentations (whole genome sequencing).
  • To understand how parasites respond to the microenvironmental conditions and define parasite survival niches (digital spatial profiling).
  • Study metabolic determinants of skin immunity (e.g. lipid metabolism, bioenergetics, short-chain fatty acids) in the context of key structural features of the skin landscape known to influence local metabolism and immune response (e.g. adipose tissue, follicles, microvasculature) (SpatialOMx).
  • To investigate the association between patient outcomes and the above host/parasite factors at baseline.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin Biopsy

Diagnostic Test

4mm skin biopsy

venous blood sample (plasma, PBMC, WB)

Diagnostic Test

venous blood sample to acquire plasma, PBMCs and whole blood

venous blood sample (HLA)

Genetic

venous blood sample used for HLA typing

skin slit

Genetic

genome sequencing of parasite DNA that is extracted from the skin slit

Primary outcomes

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

    Time frame: Day 0

    Using single cell RNA sequencing and digital spatial profiling methods, we will profile the full heterogeneity in healthy skin/lesion immunity and the cellular microenvironment surrounding infected and non-infected macrophages, respectively.

  2. Genomic characterization of L. aethiopica using whole genome sequencing

    Time frame: Day 0

    Whole genome sequencing will allow us to study the genomic diversity of L. aethiopica and identify features associated with the different clinical presentations.

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

    Time frame: Day 0

    The digital spatial profiling will indicate the different microenvironmental conditions and parasite survival niches.

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

    Time frame: Day 0

    The metabolic determinants of skin immunity (e.g. lipid metabolism, bioenergetics, short-chain fatty acids) in the context of key structural features of the skin landscape known to influence local metabolism and immune response (e.g. adipose tissue, follicles, microvasculature) will be studied by SpatialOMx.

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

    Time frame: Month 6

    Patients are clinically assessed at day 0 (baseline visit), day 28 and month 6. These clinical assessments include a medical questionnaire and lesion assessment, and are compared with the single cell RNA sequencing and spatial resolution data to define potential causal relations between patient outcomes and immunometabolic factors.

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Maastricht University
  • University Hospital, Antwerp
  • University of Gondar
  • University of York

Registry information

Official study title

Spatial Analysis of Host-parasite Interactions in the Skin Across the Clinical Spectrum of Cutaneous Leishmaniasis in Ethiopia

Acronym: SpatialCL

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2022
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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