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Completed

NCT Number: NCT03837431

Cutaneous Leishmaniasis Diagnostic Study

The performance of the CL Detect Rapid test will be tested in individuals with suspected cutaneous leishmaniasis in Ethiopia using both skin slit and dental broach samples against a combined reference of microscopy and PCR. Alternative sampling methods will also be evaluated.

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Key information

Conditions

Cutaneous Leishmaniases Euglenozoa Infections Infections Leishmaniasis Leishmaniasis, Cutaneous Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leishmania Research and Treatment Center, University of Gondar hospital

Gonder, Ethiopia

About this study

Cutaneous Leishmaniasis is common in Ethiopia and mainly affects the poor living in rural areas. Diagnosis of CL routinely uses invasive skin slits which are examined with microscopy, requiring trained staff and an equipped lab. A new rapid diagnostic test for CL which may be used in the field has been developed and validated in several countries where other Leishmania species are present. Less invasive tape sampling has also become available. Whether this new RDT and alternative sampling methods can be used in Ethiopia is unclear.

The performance of the CL detect Rapid Test against a combined reference (microscopy and PCR) and alternative sample collection methods will be tested in CL suspected individuals in North-West Ethiopia in a cross-sectional study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical suspicion of CL

Exclusion criteria

  • ≤ 2 years of age
  • Not willing or able to provide consent/assent
  • CL presentation with only lesions for which skin slit samples cannot be obtained (e.g. eyelids)
  • Co-morbidity with visceral leishmaniasis
  • On CL treatment at time of enrollment

Treatment and study plan

Skin slit

Diagnostic Test

Skin slit microscopy, RDT and PCR

Dental broach

Diagnostic Test

Dental broach RDT and PCR

Tape disc

Diagnostic Test

Tape disc PCR

Primary outcomes

  1. Sensitivity, specificity of CL detect Rapid Test using skin slit sampling

    Time frame: February 2019

    % test positive/negative compared against a combined reference of microscopy and PCR with skin slit sampling(positive if any of the two are positive)

Secondary outcomes

  1. Sensitivity, specificity of CL detect Rapid Test using dental broach sampling

    Time frame: February 2019

    CL detect Rapid Test against combined reference of microscopy and PCR using skin slit sampling

  2. Sensitivity, specificity of CL detect Rapid Test with skin slit or dental broach sampling

    Time frame: May 2018

    CL detect Rapid Test with skin slit sample against CL detect Rapid Test with dental broach sample

  3. Sensitivity, specificity of CL detect Rapid Test compared to routine

    Time frame: February 2019

    CL detect Rapid Test positive/negative with skin slit sample compared to microscopy with skin slit sample

  4. Sensitivity, specificity of dental broach sample compared to skin slit sample

    Time frame: February 2019

    PCR with dental broach compared to PCR with skin slit sample

  5. Sensitivity, specificity of tape disc sampling

    Time frame: February 2019

    PCR with tape disc sampling compared to PCR with skin slit sampling

  6. Sensitivity, specificity of routine testing

    Time frame: February 2019

    Microscopy with skin slit sampling compared to PCR with skin slit sampling

  7. Species identification

    Time frame: February 2019

    For selected CL lesions species identification will be done

  8. Immunomodulatory mediators in CL lesions using non-invasive sampling

    Time frame: February 2019

    Tape disc samples will be used and correlation with lesion severity will be assessed

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Registry information

Official study title

Diagnosis of Cutaneous Leishmaniasis Using the CL-Detect Rapid Test in Ethiopia

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Feb 12, 2019
Registry last updated
Mar 1, 2023

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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