Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis

This study has been completed.
Sponsor:
Collaborator:
InBios International, Inc.
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01865032
First received: May 23, 2013
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus the gold standard for Leishmania diagnosis in the US which is microscopic identification of Leishmania amastigotes in a stained lesion sample. Subjects will be patients who present for dermatology consultation with a primarily ulcerated lesion. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected from the subject's lesion in the following order: 1) one sample will be obtained with a dental broach for use with the CL Detect™ Rapid Test and 2) a second sample will be obtained by scraping for use in the microscopic identification of amastigotes. Samples will be analyzed by microscopy and CL Detect™ Rapid Test. The CL Detect™ Rapid Test will be performed by different operators who are clinical staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently. Each of the 150 study subjects will be followed administratively to the point where a diagnosis is established (if possible) for their tested lesion, even if that diagnosis is not cutaneous leishmaniasis (CL). If a specific diagnosis cannot be determined for a non-CL lesion, the investigator will assign a "likely etiology" (eg, infectious, oncological, immunological, vascular, or "undetermined/other" origin). Based on the diagnosis determined for each lesion, subjects will be referred for appropriate treatment.


Condition
Skin Diseases

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pivotal Trials: Evaluation of a Rapid Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in the United States

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Specificity [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Specificity will be presented for the CL Detect™ Rapid Test device against the reference method (microscopy). Specificity will be calculated as the number of true negatives divided by the sum of the number of true negatives plus the number of false positives times 100%.


Secondary Outcome Measures:
  • False positive rate [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    α, type 1 error, calculated as 1-specificity times 100%

  • False negative rate [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    β, type 2 error, calculated as 1-sensitivity times 100%


Biospecimen Retention:   Samples With DNA

dental broach samples in lysis buffer


Enrollment: 150
Study Start Date: June 2013
Study Completion Date: April 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Skin Ulcers
Skin ulcers. No intervention. Subjects will be followed up by their respective primary providers.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Dermatology clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865032

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
InBios International, Inc.
Investigators
Principal Investigator: Mark Lebwohl, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01865032     History of Changes
Other Study ID Numbers: S-12-19
Study First Received: May 23, 2013
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

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

ClinicalTrials.gov processed this record on November 20, 2014