Leishmaniasis, CutaneousNCT03762070
Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru
An observational study of Leishmaniasis, Cutaneous, run by Naval Medical Research Center at 2 sites in Peru.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leishmaniasis, Cutaneous
- What is being tested?
- CL Detect™ Rapid Test
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesPeru
- Study dates
- 2 Oct 2018to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Received treatment for leishmaniasis within the last 2 months prior to evaluation.
- In the opinion of the investigator, evidence of manipulation of the lesion.
Trial locations and contacts
2 sites in 1 country.
Peru2 sites, 2 recruiting
- Recruiting
Universidad Peruana Cayetano Heredia (UPCH)
Lima
Ana Ramos, M.D., ana.ramos.t@upch.pe
Alejandro Llanos-Cuentas, M.D., Ph.D
- Recruiting
U.S. Naval Medical Research Center Unit No. 6 (NAMRU-6)
Puerto Maldonado
Luis Angel Rosales, 51-982-328-888
About this study
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.
Read the 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:
- one sample obtained with a dental broach for use with the CL Detect™ Rapid Test;
- one sample obtained by scraping for microscopic identification of amastigotes; and
- one sample obtained by scraping for Leishmania speciation by PCR; and
- 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.
- Conditions
- Leishmaniasis, Cutaneous
- Being tested
- CL Detect™ Rapid Test
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CL Detect™ Rapid TestDevice
Observational study of a FDA cleared device, the CL Detect™ Rapid Test.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test when scraping is used to obtain tissue samples.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start2 Oct 2018
- Primary completionMar 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leishmaniasis, CutaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naval Medical Research Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dr. Max Grogl, Naval Medical Research Center
- Investigators
- Max Grogl, Ph.D., Principal investigator, Scientific Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762070
- Sponsor's protocol ID
- LRDD-PERU-02
- Status last verified
- Nov 2018
- First submitted
- 30 Nov 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 36913433
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru
- ClinicalTrials.gov ID
- NCT03762070
- Acronym / sponsor ID
- LRDD-PERU-02
- Conditions
- Leishmaniasis, Cutaneous
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Naval Medical Research CenterUS federal agency
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- one sample obtained with a dental broach for use with the CL Detect™ Rapid Test;
- one sample obtained by scraping for microscopic identification of amastigotes; and
- one sample obtained by scraping for Leishmania speciation by PCR; and
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
- Capable of understanding and complying with the protocol, in the opinion of the evaluator
Key exclusion criteria (2 listed)
- Received treatment for leishmaniasis within the last 2 months prior to evaluation.
- In the opinion of the investigator, evidence of manipulation of the lesion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CL Detect™ Rapid TestObservational study of a FDA cleared device, the CL Detect™ Rapid Test. | Device | – |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Derived from this study: PubMed 36913433Grogl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Grogl, Ph.D. principal investigator
Scientific Director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leishmaniasis, Cutaneous, run by Naval Medical Research Center at 2 sites in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Max Grogl, Ph.D. (51-1-614-4159, max.grogl1.civ@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance (sensitivity and specificity) of the CL Detect™ Rapid Test (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03762070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2018.