Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03762070
Other study ID # LRDD-PERU-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2, 2018
Est. completion date April 2019

Study information

Verified date November 2018
Source Naval Medical Research Center
Contact Max Grogl, Ph.D.
Phone 51-1-614-4159
Email max.grogl1.civ@mail.mil
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date April 2019
Est. primary completion date March 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Peru Universidad Peruana Cayetano Heredia (UPCH) Lima
Peru U.S. Naval Medical Research Center Unit No. 6 (NAMRU-6) Puerto Maldonado

Sponsors (1)

Lead Sponsor Collaborator
Naval Medical Research Center

Country where clinical trial is conducted

Peru, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test when scraping is used to obtain tissue samples. Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test when scraping is used to obtain tissue samples. 1 day
See also
  Status Clinical Trial Phase
Terminated NCT01140191 - Safety, Efficacy, and PK of Topical Paromomycin/Gentamicin Cream for Treatment of Cutaneous Leishmaniasis Phase 2
Completed NCT03999970 - A Clinical Study to Develop an Uninfected Sand Fly Biting Protocol N/A
Completed NCT00111553 - Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis Phase 1
Completed NCT02894008 - A Study of a New Leishmania Vaccine Candidate ChAd63-KH Phase 2
Completed NCT03303898 - ASYMPTOMATIC CARRIER OF LEISHMANIA INFANTUM, MEDISERRANEAN VISCERAL LEISHMANIOSIS AGENT: STUDY OF IMMUNE RESPONSE - N/A
Recruiting NCT05094908 - Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis Phase 1
Completed NCT01083576 - Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama Phase 2
Completed NCT03445897 - Miltefosine Plus IL Pentamidine for Bolivian CL Phase 2
Withdrawn NCT04072874 - Evaluation of the Safety and Clinical Activity of Curaleish in the Topical Treatment of Cutaneous Leishmaniasis. Phase 1/Phase 2
Completed NCT01032382 - Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK) Phase 2
Completed NCT00480883 - Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate Versus Meglumine Antimoniate and Allopurinol N/A
Recruiting NCT05708625 - Intralesional Voriconazole, or Intralesional Cryotherapy, or Oral Doxycycline in the Treatment of Cutaneous Leishmaniasis Phase 3
Completed NCT04841239 - Development of Topical Herbal Formulations for Treatment of Cutaneous Leishmaniasis N/A
Completed NCT00469495 - Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis N/A
Completed NCT03294161 - Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis Phase 2
Completed NCT04888130 - Investigation of an Outbreak Situation of Cutaneous Leishmaniasis Among Military Personnel in French Guiana (CEFELEISH)
Completed NCT03969134 - A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL Phase 2
Completed NCT03096457 - Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia Phase 2/Phase 3
No longer available NCT01641796 - Paromomycin for Individuals With Uncomplicated Cutaneous Leishmaniasis
No longer available NCT00508963 - Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis