NCT03837431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

February 13, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

3.5 years

First QC Date

February 8, 2019

Last Update Submit

February 28, 2023

Conditions

Cutaneous Leishmaniases

Keywords

CutaneousLeishmaniasisEthiopiaRDT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Sensitivity, specificity of CL detect Rapid Test using dental broach sampling

    February 2019

  • Sensitivity, specificity of CL detect Rapid Test with skin slit or dental broach sampling

    May 2018

  • Sensitivity, specificity of CL detect Rapid Test compared to routine

    February 2019

  • Sensitivity, specificity of dental broach sample compared to skin slit sample

    February 2019

  • Sensitivity, specificity of tape disc sampling

    February 2019

  • +3 more secondary outcomes

Study Arms (1)

CL suspicion

Individuals presenting with clinical suspicion of CL

Diagnostic Test: Skin slitDiagnostic Test: Dental broachDiagnostic Test: Tape disc

Interventions

Skin slitDIAGNOSTIC_TEST

Skin slit microscopy, RDT and PCR

CL suspicion
Dental broachDIAGNOSTIC_TEST

Dental broach RDT and PCR

CL suspicion
Tape discDIAGNOSTIC_TEST

Tape disc PCR

CL suspicion

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • \- Clinical suspicion of CL

You may not qualify if:

  • ≤ 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leishmania Research and Treatment Center, University of Gondar hospital

Gonder, Ethiopia

Location

Related Publications (1)

  • 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.

    PMID: 35041672DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Skin samples will be stored (skin slit smear, dental broach sample, tape sample) for a period of one year after the end of the study for quality assurance testing. If patients consented to long-term storage and secondary use of their samples, the skin samples will be stored for a period up to 25 years.

MeSH Terms

Conditions

Leishmaniasis, CutaneousLeishmaniasis

Condition Hierarchy (Ancestors)

Euglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Johan van Griensven, MD, PhD

    Institute of Tropical Medicine, Antwerp, Belgium

    STUDY CHAIR

  • Rezika Mohammed, MD

    College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2019

First Posted

February 12, 2019

Study Start

February 13, 2019

Primary Completion

August 12, 2022

Study Completion

January 31, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

IPD accessible by managed access

Shared Documents
STUDY PROTOCOL
Time Frame
After completion of the primary publication
Access Criteria
Applicants will need to fill out a data access request form
More information

Locations

ET(1)