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

April 6, 2017 updated by: U.S. Army Medical Research and Development Command

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Gafsa, Tunisia
        • Primary Health Clinic
      • Sidi Bouzid, Tunisia
        • Primary Health Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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

Exclusion Criteria:

• Received treatment for leishmaniasis within the last 2 months prior to signing consent, with the exception of mercurochrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CL Detect Rapid Test and Microsopy Samples
Samples taken to be evaluated in the CL Detect and Microscopy assays
Other: No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results
Time Frame: within 1 hour after taking samples

Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results.

Note: only data where results for all three methods were available were included in the analysis.
within 1 hour after taking samples

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Medical Research and Development Command

Collaborators

InBios International, Inc.
Institut Pasteur of Tunis, Tunisia

Investigators

  • Principal Investigator: Afif Ben Salah, MD PhD, Institut Pasteur de Tunis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

January 14, 2013

First Submitted That Met QC Criteria

January 14, 2013

First Posted (ESTIMATE)

January 16, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 20, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-12-14
  • A-15174.2b (OTHER: HRPO)
  • K141341 (OTHER: Other)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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