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NCT03837431

Cutaneous Leishmaniasis Diagnostic Study

Completed Last updated 1 March 2023
What this trial tests

trial testing Skin slit in Cutaneous Leishmaniases in 351 participants. Completed in 31 January 2023.

Timeline
13 February 2019
Primary endpoint
12 August 2022
31 January 2023

Quick facts

Lead sponsorInstitute of Tropical Medicine, Belgium
StatusCompleted
Study typeOBSERVATIONAL
Enrollment351
Start date13 February 2019
Primary completion12 August 2022
Estimated completion31 January 2023
Sites1 location across Ethiopia

Drugs / interventions tested

Conditions studied

Sponsor

Institute of Tropical Medicine, Belgium

Who can join

2 and older, any sex, with Cutaneous Leishmaniases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Evaluation of the CL Detect Rapid Test in Ethiopian patients suspected for Cutaneous Leishmaniasis.
    van Henten S, Fikre H, Melkamu R, Dessie D, et al · · 2022 · cited 20× · PMID 35041672 · DOI 10.1371/journal.pntd.0010143
  2. First report of cutaneous leishmaniasis caused by Leishmania donovani in Ethiopia.
    Amare GA, Mekonnen GG, Kassa M, Addisu A, et al · · 2023 · cited 11× · PMID 38104111 · DOI 10.1186/s13071-023-06057-9
  3. Evaluation of Less Invasive Sampling Tools for the Diagnosis of Cutaneous Leishmaniasis.
    van Henten S, Kassa M, Fikre H, Melkamu R, et al · · 2024 · cited 7× · PMID 38560600 · DOI 10.1093/ofid/ofae113
  4. Minimally Invasive Microbiopsies as an Improved Sampling Method for the Diagnosis of Cutaneous Leishmaniasis.
    Churiso G, van Henten S, Cnops L, Pollmann J, et al · · 2020 · cited 7× · PMID 32939358 · DOI 10.1093/ofid/ofaa364
  5. Evaluation of Loopamp Leishmania detection kit for the diagnosis of cutaneous leishmaniasis in Ethiopia.
    Taye B, Melkamu R, Tajebe F, Ibarra-Meneses AV, et al · · 2024 · cited 4× · PMID 39407317 · DOI 10.1186/s13071-024-06475-3

Verify or expand the search:

Other recruiting trials for Cutaneous Leishmaniases

Currently open trials in the same condition.

Other Institute of Tropical Medicine, Belgium trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03837431.

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