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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03837431
Other study ID # 1219/18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 13, 2019
Est. completion date January 31, 2023

Study information

Verified date February 2023
Source Institute of Tropical Medicine, Belgium
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 351
Est. completion date January 31, 2023
Est. primary completion date August 12, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Skin slit
Skin slit microscopy, RDT and PCR
Dental broach
Dental broach RDT and PCR
Tape disc
Tape disc PCR

Locations

Country Name City State
Ethiopia Leishmania Research and Treatment Center, University of Gondar hospital Gondar

Sponsors (1)

Lead Sponsor Collaborator
Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity, specificity of CL detect Rapid Test using skin slit sampling % test positive/negative compared against a combined reference of microscopy and PCR with skin slit sampling(positive if any of the two are positive) February 2019
Secondary Sensitivity, specificity of CL detect Rapid Test using dental broach sampling CL detect Rapid Test against combined reference of microscopy and PCR using skin slit sampling February 2019
Secondary Sensitivity, specificity of CL detect Rapid Test with skin slit or dental broach sampling CL detect Rapid Test with skin slit sample against CL detect Rapid Test with dental broach sample May 2018
Secondary Sensitivity, specificity of CL detect Rapid Test compared to routine CL detect Rapid Test positive/negative with skin slit sample compared to microscopy with skin slit sample February 2019
Secondary Sensitivity, specificity of dental broach sample compared to skin slit sample PCR with dental broach compared to PCR with skin slit sample February 2019
Secondary Sensitivity, specificity of tape disc sampling PCR with tape disc sampling compared to PCR with skin slit sampling February 2019
Secondary Sensitivity, specificity of routine testing Microscopy with skin slit sampling compared to PCR with skin slit sampling February 2019
Secondary Species identification For selected CL lesions species identification will be done February 2019
Secondary Immunomodulatory mediators in CL lesions using non-invasive sampling Tape disc samples will be used and correlation with lesion severity will be assessed February 2019
See also
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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
Not yet recruiting NCT05493059 - Study of Cases of Cutaneous Leishmaniasis Treated With Miltefosine in French Guiana, Retrospective Study
Terminated NCT04001335 - Diagnosis of Cutaneous Leishmaniasis Using the CL-detect Rapid Test in Travelers and Migrants in Belgium
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