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

Skin Diseases, Parasitic Clinical Trial

— CL Detect™  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769612
• Other study ID #: S-12-14
• Secondary ID: A-15174.2bK14134
• Status: Completed
• Phase: N/A
• First received: January 14, 2013
• Last updated: November 3, 2016
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: September 2014
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationTunisia: Ministry of Public Health
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Cutaneous
• Parasitic Diseases
• Skin Diseases
• Skin Diseases, Parasitic

Intervention

Other:
• No Intervention

Locations

Country	Name	City	State
Tunisia	Primary Health Clinic	Gafsa
Tunisia	Primary Health Clinics	Sidi Bouzid

Sponsors (2)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command	InBios International, Inc.

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive result for CL Detect		1 hour	No