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

This study has been completed.
InBios International, Inc.
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command Identifier:
First received: January 14, 2013
Last updated: November 3, 2016
Last verified: September 2014
The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.

Condition Intervention
Skin Diseases, Parasitic
Other: No Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Rapid Diagnostic Device, CL Detect™, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia

Resource links provided by NLM:

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Positive result for CL Detect [ Time Frame: 1 hour ]

Enrollment: 150
Study Start Date: January 2013
Study Completion Date: April 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic

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

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Please refer to this study by its identifier: NCT01769612

Primary Health Clinic
Gafsa, Tunisia
Primary Health Clinics
Sidi Bouzid, Tunisia
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
InBios International, Inc.
Principal Investigator: Afif Ben Salah, MD PhD Institut Pasteur of Tunis
  More Information

Responsible Party: U.S. Army Medical Research and Materiel Command Identifier: NCT01769612     History of Changes
Other Study ID Numbers: S-12-14
A-15174.2b ( Other Identifier: HRPO )
K141341 ( Other Identifier: Other )
Study First Received: January 14, 2013
Last Updated: November 3, 2016

Additional relevant MeSH terms:
Skin Diseases
Leishmaniasis, Cutaneous
Parasitic Diseases
Skin Diseases, Parasitic
Euglenozoa Infections
Protozoan Infections
Skin Diseases, Infectious processed this record on May 25, 2017