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NCT03837431
Cutaneous Leishmaniasis Diagnostic Study
trial testing Skin slit in Cutaneous Leishmaniases in 351 participants. Completed in 31 January 2023.
12 August 2022
Quick facts
| Lead sponsor | Institute of Tropical Medicine, Belgium |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 351 |
| Start date | 13 February 2019 |
| Primary completion | 12 August 2022 |
| Estimated completion | 31 January 2023 |
| Sites | 1 location across Ethiopia |
Drugs / interventions tested
- Skin slit
- Dental broach
- Tape disc
Conditions studied
- Cutaneous Leishmaniases — all drugs for Cutaneous Leishmaniases →
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):
-
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03837431
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cutaneous Leishmaniases
Currently open trials in the same condition.
- NCT06514560 — OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients · recruiting
Other Institute of Tropical Medicine, Belgium trials
Trials by the same sponsor.
- NCT07463040 — Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL) · Phase 3 · not yet recruiting
- NCT07174648 — Testing of a New Rapid Antigen Test for Plague in Ituri, Democratic Republic of the Congo. · not yet recruiting
- NCT07499739 — Mpox Biology, Outcome, Transmission and Epidemiology - Tracking the Immune Response After mpoX vaCcination (MBOTE-TRAXX) · Phase 4 · not yet recruiting
- NCT07342829 — Prospective Follow-up After MVA-BN Booster Vaccination · not yet recruiting
- NCT06839989 — An Immunogenicity and Safety Trial of MVA-BN in Adults Living With HIV for the Prevention of Mpox Infection, in Kinshasa · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03837431 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Tropical Medicine, Belgium
- Last refreshed: 1 March 2023
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing