Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.

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

Cutaneous Leishmaniasis Skin Diseases, Parasitic Neglected Diseases

COMPLETED

Cutaneous Leishmaniasis Diagnostic Study

NCT03837431

Cutaneous Leishmaniases

COMPLETED

Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru

NCT03762070

Leishmaniasis, Cutaneous

UNKNOWN

Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World

NCT00703924

Cutaneous Leishmaniasis

COMPLETED PHASE2

Clinical Investigation of Infections Due to Leishmanial Parasites

NCT00001169

Leishmaniasis Leishmaniasis, Visceral

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjects were selected based on clinical appearance of the skin lesion characteristics of cutaneous leishmaniasis (CL). Study compared the CL Detect Rapid Test vs microscopic identification of Leishmania amastigotes in a stained lesion sample. Two diagnostic samples were collected from the subjects lesion in the following order: 1) obtained with a dental broach for use with the CL Detect Rapid Test and 2) a second sample was obtained by scraping for use in the microscopic identification of amastigotes. Samples were analyzed by microscopy and CL Detect Repaid Test by different operators who evaluated each sample independently blinded to the other assay result.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Skin Diseases, Parasitic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CL Detect Rapid Test and Microsopy Samples

Samples taken to be evaluated in the CL Detect and Microscopy assays

No Intervention

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No Intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* At least 18 years of age and generally healthy
* Subject able to give written informed consent
* Subject has a lesion suspicious for leishmaniasis that satisfies the following criteria for an index lesion:

* less than 4 months in age
* primarily ulcerative, ie not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis
* in a location suitable for collecting samples by dental broach, scraping, and aspiration
* In the opinion of the investigator, the subject is capable of understanding and complying with the protocol