Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01865032
• Date of registration: 23/05/2013
• Prospective Registration: Yes
• Primary sponsor: U.S. Army Medical Research and Materiel Command
• Public title: Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis
• Scientific title: Pivotal Trials: Evaluation of a Rapid Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in the United States
• Date of first enrolment: June 2013
• Target sample size: 150
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01865032
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Mark Lebwohl, MD
• Affiliation: Mount Sinai School of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- At least 18 years of age

- Subject is able to give written informed consent

- Subject has a skin ulcer that satisfies the following criteria for an index lesion:

- less than 4 months in age

- primarily ulcerative, not purely verrucous or nodular, and does not have clear
clinical evidence of cellulitis

- in a location suitable for collecting samples by dental broach and scraping

- In the opinion of the investigator, the subject is capable of understanding and
complying with the protocol

Exclusion Criteria:

- Received treatment for leishmaniasis or any treatment to the lesion even if not
previously diagnosed as leishmaniasis such as azoles, cryotherapy, imiquimod,
thermotherapy, photodynamic therapy, within 2 months prior to signing the consent
form, with the exception of mercurochrome



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Skin Diseases

Primary Outcome(s)

Specificity [Time Frame: 1 hour]

Secondary Outcome(s)

False negative rate [Time Frame: 1 hour]

False positive rate [Time Frame: 1 hour]

Secondary ID(s)

S-12-19

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

InBios International, Inc.