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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04001335
Other study ID # 1298/19
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date August 12, 2019
Est. completion date March 1, 2021

Study information

Verified date March 2021
Source Institute of Tropical Medicine, Belgium
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cutaneous Leishmaniasis (CL) is a neglected tropical disease which is increasingly seen in travelers and migrants evaluated in travel clinics of non-endemic countries. Various CL species are present in different parts of the world, and these different species vary in severity, prognosis and therapeutic approaches. At ITM, diagnosis of CL in suspected patients is done using a skin biopsy, analyzed by diagnostic PCR, and species typing PCR. This method is invasive, and diagnosis is often delayed for days to weeks. The new antigen-based CL Detect Rapid Test uses dental broach sampling and has results within 30 minutes. Dental broach samples left over from the Cl Detect Rapid test may still be used for PCR including species typing. How well the CL Detect Rapid Test performs in the varied population of a travel clinic and whether it is possible to use dental broach sampling for further PCR tests in this population needs to be evaluated The aim of this study is to study the performance of the CL Detect Rapid Test and whether dental broach sampling can replace skin biopsy for CL at ITM.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Skin biopsy for leishmania test requested by treating ITM clinician OR - externally requested skin biopsy for Leishmania tested at ITM with an ITM consultation <7 days of the biopsy sample - willing and able to provide consent/assent - not on CL treatment

Study Design


Intervention

Diagnostic Test:
Dental Broach
Dental broach, RDT and PCR

Locations

Country Name City State
Belgium Institute of Tropical Medicine Antwerp

Sponsors (1)

Lead Sponsor Collaborator
Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of CL detect RDT Against combined reference of microscopy and PCR using skin punch biopsy 2019-2010
Secondary Proportion of PCR positives on dental broach sample Compared to PCR positives on skin punch biopsy 2019-2020
Secondary Proportion of successful species typing on dental broach sample Compared to successful species typing on skin punch biopsy sample 2019-2020
See also
  Status Clinical Trial Phase
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Completed NCT04512742 - A Clinical Study to Develop a Controlled Human Infection Model Using Leishmania Major-infected Sand Flies N/A
Completed NCT04004754 - Outcomes of Complicated CL in Ethiopia Treated With Miltefosine
Active, not recruiting NCT05332093 - Spatial Analysis of Host-parasite Interactions in Cutaneous Leishmaniasis in Ethiopia
Active, not recruiting NCT04515186 - Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World Phase 3
Completed NCT02919605 - Efficacy and Safety of Pentamidine (7mg/kg) for Patients With Cutaneous Leishmaniasis Caused by L. Guyanensis Phase 2
Completed NCT03837431 - Cutaneous Leishmaniasis Diagnostic Study
Not yet recruiting NCT05493059 - Study of Cases of Cutaneous Leishmaniasis Treated With Miltefosine in French Guiana, Retrospective Study
Completed NCT03929016 - Single Oral Dose Escalation Study of DNDI-0690 in Healthy Subjects Phase 1
Completed NCT03435419 - Evaluation of Point-of-care Tests for the Diagnosis of Cutaneous Leishmaniasis in Afghanistan N/A