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

This study is currently recruiting participants.
Verified February 2013 by U.S. Army Medical Research and Materiel Command
Sponsor:
Collaborator:
InBios International
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01769612
First received: January 14, 2013
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  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 Rapid Diagnostic Device, CL Detect™, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 167
Study Start Date: January 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769612

Contacts
Contact: Afif Ben Salah, MD 011-216-71-792-429

Locations
Tunisia
Primary Health Clinic Recruiting
Gafsa, Tunisia
Contact: Afif Ben Salah, MD PhD     011-216-71-792-429        
Primary Health Clinics Recruiting
Sidi Bouzid, Tunisia
Contact: Afif Ben Salah, MD PhD     011-216-71-792-429        
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
InBios International
Investigators
Principal Investigator: Afif Ben Salah, MD PhD Institut Pasteur of Tunis
  More Information

No publications provided

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
Study First Received: January 14, 2013
Last Updated: February 12, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration
Tunisia: Ministry of Public Health

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

ClinicalTrials.gov processed this record on May 23, 2013