Clinical trial NCT03837431: Cutaneous Leishmaniasis Diagnostic Study
Official title: Diagnosis of Cutaneous Leishmaniasis Using the CL-Detect Rapid Test in Ethiopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Leishmaniases
Keywords: Cutaneous
Leishmaniasis
Ethiopia
RDT
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 351
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting at the LRTC with clinically suspected CL during the study period will be screened for eligibility. Suspicion for CL is assessed by physicians as per routine care. In general, children are included in the study population since they are commonly affected, and also make up the majority of DCL patients. Very young children below the age of two are excluded as was done in other studies18 since the study does require more potentially painful procedures as compared to the routine diagnostic procedures.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity, specificity of CL detect Rapid Test using skin slit sampling
timeFrame: February 2019
Secondary outcomes:
measure: Sensitivity, specificity of CL detect Rapid Test using dental broach sampling
timeFrame: February 2019
measure: Sensitivity, specificity of CL detect Rapid Test with skin slit or dental broach sampling
timeFrame: May 2018
measure: Sensitivity, specificity of CL detect Rapid Test compared to routine
timeFrame: February 2019
measure: Sensitivity, specificity of dental broach sample compared to skin slit sample
timeFrame: February 2019
measure: Sensitivity, specificity of tape disc sampling
timeFrame: February 2019
measure: Sensitivity, specificity of routine testing
timeFrame: February 2019
measure: Species identification
timeFrame: February 2019
measure: Immunomodulatory mediators in CL lesions using non-invasive sampling
timeFrame: February 2019
Other outcomes:
Locations:
city: Gondar
country: Ethiopia
facility: Leishmania Research and Treatment Center, University of Gondar hospital
Study officials:
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
name: Johan van Griensven, MD, PhD
role: STUDY_CHAIR
affiliation: College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
name: Rezika Mohammed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Henten S, Fikre H, Melkamu R, Dessie D, Mekonnen T, Kassa M, Bogale T, Mohammed R, Cnops L, Vogt F, Pareyn M, van Griensven J. Evaluation of the CL Detect Rapid Test in Ethiopian patients suspected for Cutaneous Leishmaniasis. PLoS Negl Trop Dis. 2022 Jan 18;16(1):e0010143. doi: 10.1371/journal.pntd.0010143. eCollection 2022 Jan.