Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 1403 for:    Peru

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03762070
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Max Grogl, Naval Medical Research Center

Brief Summary:
Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test in Peru, using a test procedure that was modified from that described in the device instructions to optimize these parameters for the detection of Leishmania species identified in Peru.

Condition or disease Intervention/treatment
Leishmaniasis, Cutaneous Device: CL Detect™ Rapid Test

Detailed Description:

Observational study of a FDA cleared device, the CL Detect™ Rapid Test. Data for the 510(K) was supported by a sensitivity study conducted in Tunisia, Old world Leishamania major and a specificity study conducted in the United Sates. Sensitivity and specificity data collected recently in Peru (2014-2015), by the Instituto de Medicina Tropical Alexander von Humbolt, supports the idea that the sensitivity of the CL Detect™ Rapid Test can be drastically increased for New World Leishmania species. The study is a single trial, with two clinical sites, NAMRU-6, Puerto Maldonado and the Alexander von Humboldt Tropical Medicine Institute in Lima. The objective of the study is to determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test, using an optimized test procedure determined from a pilot study conducted in Peru. Two modifications to the test procedure (marketed device instructions) are included in this study: 1) increase in extraction time in lysis buffer from 5 to 10 minutes to 20 to 30 minutes and 2) a 20 μl increase in the volume of the sample to add to the test strip, from 20 μl to 40 μl. The gold standard for Leishmania diagnosis, which is microscopic identification of amastigotes in stained lesion sample, will be used as a control.

Participants will be patients who present for medical consultation due to a suspected CL lesion. After obtaining informed consent and screening the participant for eligibility, we will collect and test at most 4 samples from the index lesion in the following order:

  1. one sample obtained with a dental broach for use with the CL Detect™ Rapid Test;
  2. one sample obtained by scraping for microscopic identification of amastigotes; and
  3. one sample obtained by scraping for Leishmania speciation by PCR; and
  4. when possible, (depending on the size of the lesion), one sample from a different site of the same lesion, obtained by scraping for use with the CL Detect™ Rapid Test. PCR analysis will be performed by NAMRU-6 for possible exploratory analyses including species identification. If the etiologies of the lesions that are negative for Leishmania are known, they will be reported. Participants with a positive diagnosis of leishmaniasis by microscopy or other methods will be referred for standard of care treatment in Peru by the attending physician of the Peruvian Ministry of Health. Treatment is not part of this study. If a participant's lesions are negative for Leishmania, standard of care follow-up testing will be performed, either at the study site, or (when indicated) in another hospital.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Chlorine


Intervention Details:
  • Device: CL Detect™ Rapid Test
    Observational study of a FDA cleared device, the CL Detect™ Rapid Test.


Primary Outcome Measures :
  1. The performance (sensitivity and specificity) of the CL Detect™ Rapid Test [ Time Frame: 1 day ]
    Sensitivity and specificity of CL Detect™ Rapid Test will be determined by comparing with the gold standard, microscopy of stained lesion samples for identification of Leishmania amastigotes. The following definitions apply to the calculation of assay sensitivity and specificity: 1. True positive: Positive by both the CL Detect™ Rapid Test and the reference method. 2. False positive: Positive by the CL Detect™ Rapid Test but negative for the reference method. 3. True negative: Negative by both the CL Detect™ Rapid Test and the reference method. 4. False negative: Negative by the CL Detect™ Rapid Test but positive for the reference method.


Secondary Outcome Measures :
  1. Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test when scraping is used to obtain tissue samples. [ Time Frame: 1 day ]
    Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test when scraping is used to obtain tissue samples.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The study population consists of male and female participants, ages 18 years and older, with a clinically suspected CL lesion. It is estimated that up to 200 participants may need to be consented, screened, and tested in order to obtain 100 participants/samples who are positive by microscopy for Leishmania, using minimally modified (from the device instructional insert) test conditions determined to be optimal in a pilot study. If a higher percentage of participants are negative by microscopy than is estimated, then the total sample size will be increased to obtain a total of 100 participants positive by microscopy.
Criteria

Inclusion Criteria:

  • At least 18 years of age and generally healthy.
  • Able to provide written informed consent.
  • Index lesion present that is suspicious for CL, as defined by the following criteria for an index lesion:

    1. less than 2 months in age
    2. primarily ulcerative, i.e. not purely verrucous or nodular
    3. no clear clinical evidence of cellulitis
    4. location suitable for collecting samples by dental broach and scraping.
  • Capable of understanding and complying with the protocol, in the opinion of the evaluator

Exclusion Criteria:

  • Received treatment for leishmaniasis within the last 2 months prior to evaluation.
  • In the opinion of the investigator, evidence of manipulation of the lesion.

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): NCT03762070


Contacts
Layout table for location contacts
Contact: Max Grogl, Ph.D. 51-1-614-4159 max.grogl1.civ@mail.mil

Locations
Layout table for location information
Peru
Universidad Peruana Cayetano Heredia (UPCH) Recruiting
Lima, Peru
Contact: Ana Ramos, M.D.       ana.ramos.t@upch.pe   
Sub-Investigator: Alejandro Llanos-Cuentas, M.D., Ph.D         
U.S. Naval Medical Research Center Unit No. 6 (NAMRU-6) Recruiting
Puerto Maldonado, Peru
Contact: Luis Angel Rosales    51-982-328-888      
Sponsors and Collaborators
Naval Medical Research Center
Investigators
Layout table for investigator information
Principal Investigator: Max Grogl, Ph.D. Scientific Director

Layout table for additonal information
Responsible Party: Dr. Max Grogl, Scientific Director, Naval Medical Research Center
ClinicalTrials.gov Identifier: NCT03762070     History of Changes
Other Study ID Numbers: LRDD-PERU-02
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases