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

NCT03762070 | Unknown FDA Device

• 1 other identifier: LRDD-PERU-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Leishmaniasis, Cutaneous

Outcome Measures

Primary Outcomes (1)

• The performance (sensitivity and specificity) of the CL Detect™ Rapid Test

  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.

  1 day

Secondary Outcomes (1)

• Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test when scraping is used to obtain tissue samples.

  1 day

Interventions

CL Detect™ Rapid Test DEVICE

Observational study of a FDA cleared device, the CL Detect™ Rapid Test.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Naval Medical Research Center: lead

Study Sites (2)

Universidad Peruana Cayetano Heredia (UPCH)

Lima, Peru

RECRUITING

U.S. Naval Medical Research Center Unit No. 6 (NAMRU-6)

Puerto Maldonado, Peru

RECRUITING

Related Publications (1)

• Grogl M, Joya CA, Saenz M, Quispe A, Rosales LA, Santos RDP, De Los Santos MB, Donovan N, Ransom JH, Ramos A, Llanos Cuentas E. Evaluation of a diagnostic device, CL Detect rapid test for the diagnosis of new world cutaneous leishmaniasis in Peru. PLoS Negl Trop Dis. 2023 Mar 13;17(3):e0011054. doi: 10.1371/journal.pntd.0011054. eCollection 2023 Mar.

  PMID: 36913433 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Max Grogl, Ph.D.

  Scientific Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Max Grogl, Ph.D.

CONTACT

51-1-614-4159; max.grogl1.civ@mail.mil

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 3, 2018
• Study Start: October 2, 2018
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 3, 2018

Record last verified: 2018-11

Locations

PE (2)