Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
351 participants
OBSERVATIONAL
2019-02-13
2023-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco
NCT02979002
Spatial Analysis of Host-parasite Interactions in Cutaneous Leishmaniasis in Ethiopia
NCT05332093
Evaluation of a Diagnostic Device, CL Detectâ„¢ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru
NCT03762070
Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia
NCT01769612
Diagnosis and Treatment of Leishmania Infections
NCT00344188
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CL suspicion
Individuals presenting with clinical suspicion of CL
Skin slit
Skin slit microscopy, RDT and PCR
Dental broach
Dental broach RDT and PCR
Tape disc
Tape disc PCR
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Skin slit
Skin slit microscopy, RDT and PCR
Dental broach
Dental broach RDT and PCR
Tape disc
Tape disc PCR
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
2 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute of Tropical Medicine, Belgium
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Johan van Griensven, MD, PhD
Role: STUDY_CHAIR
Institute of Tropical Medicine, Antwerp, Belgium
Rezika Mohammed, MD
Role: PRINCIPAL_INVESTIGATOR
College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Leishmania Research and Treatment Center, University of Gondar hospital
Gonder, , Ethiopia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1219/18
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.