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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01769612
First Posted: January 16, 2013
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
InBios International, Inc.
Institut Pasteur of Tunis, Tunisia
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
  Purpose
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 Diagnostic Device, CL Detect Rapid Test, 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 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.



Enrollment: 168
Study Start Date: January 2013
Study Completion Date: April 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CL Detect Rapid Test and Microsopy Samples
Samples taken to be evaluated in the CL Detect and Microscopy assays
Other: No Intervention

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.
  Eligibility

Information from the National Library of Medicine

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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
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769612


Locations
Tunisia
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.
Institut Pasteur of Tunis, Tunisia
Investigators
Principal Investigator: Afif Ben Salah, MD PhD Institut Pasteur of Tunis
  More Information

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01769612     History of Changes
Other Study ID Numbers: S-12-14
A-15174.2b ( Other Identifier: HRPO )
K141341 ( Other Identifier: Other )
First Submitted: January 14, 2013
First Posted: January 16, 2013
Results First Submitted: February 13, 2017
Results First Posted: June 20, 2017
Last Update Posted: June 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by U.S. Army Medical Research and Materiel Command:
Leishmaniasis, Leishmania

Additional relevant MeSH terms:
Leishmaniasis
Skin Diseases
Leishmaniasis, Cutaneous
Parasitic Diseases
Skin Diseases, Parasitic
Euglenozoa Infections
Protozoan Infections
Skin Diseases, Infectious


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