CompletedNot Applicable

Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis

United States150 participantsStarted 2013-06

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

True Positive

Timeframe: within 1 hour after samples are taken

False Positive

Timeframe: within 1 hour after samples are taken

True Negative

Timeframe: within 1 hour after samples are taken

False Negative

Timeframe: within 1 hour after samples are taken

Specificity

Timeframe: within 1 hour after samples are taken

False Positive Rate

Timeframe: within 1 hour after samples are taken

Trial details

NCT IDNCT01865032

SponsorU.S. Army Medical Research and Development Command

Sponsor typeFED

Study typeOBSERVATIONAL

Primary completion2013-08

Results submitted2017-02-15

View on ClinicalTrials.gov More Skin Diseases trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

True Positive

Timeframe: within 1 hour after samples are taken

False Positive

Timeframe: within 1 hour after samples are taken

True Negative

Timeframe: within 1 hour after samples are taken

False Negative

Timeframe: within 1 hour after samples are taken

Specificity

Timeframe: within 1 hour after samples are taken

False Positive Rate

Timeframe: within 1 hour after samples are taken