Trial Outcomes & Findings for Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis (NCT NCT01865032)

NCT ID: NCT01865032

Last Updated: 2026-02-25

Results Overview

Positive by both the CL Detect™ Rapid Test and microscopy of an index lesion smear for amastigotes.

Recruitment status

COMPLETED

Target enrollment

150 participants

Primary outcome timeframe

within 1 hour after samples are taken

Results posted on

2026-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	Evaluation the CL Detect Rapid Test on Skin Ulcers Ulcerated skin lesions will be evaluated for Leishmaniasis using the CL Detect Rapid Test vs microscopy.
Overall Study STARTED	150
Overall Study COMPLETED	150
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CL Detect Rapid Test on Skin Ulcers n=150 Participants Ulcerated skin lesions will be evaluated for Leishmaniasis using the CL Detect Rapid Test vs microscopy.
Age, Continuous	54.1 years STANDARD_DEVIATION 20 • n=24 Participants
Sex: Female, Male Female	86 Participants n=24 Participants
Sex: Female, Male Male	64 Participants n=24 Participants
Race/Ethnicity, Customized White	121 Participants n=24 Participants
Race/Ethnicity, Customized Black or African American	14 Participants n=24 Participants
Race/Ethnicity, Customized Asian	14 Participants n=24 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=24 Participants
Region of Enrollment United States	150 participants n=24 Participants
Lesion Age	17.8 days STANDARD_DEVIATION 25.0 • n=24 Participants
Lesion Characteristics Ulcerated	150 Participants n=24 Participants
Lesion Characteristics Nodular	3 Participants n=24 Participants
Lesion Characteristics Secondary bacterial infection	31 Participants n=24 Participants
Lesion Location Abdomen	3 Participants n=24 Participants
Lesion Location Arm	8 Participants n=24 Participants
Lesion Location Back	13 Participants n=24 Participants
Lesion Location Back of Head	4 Participants n=24 Participants
Lesion Location Buttocks	3 Participants n=24 Participants
Lesion Location Face	25 Participants n=24 Participants
Lesion Location Foot	24 Participants n=24 Participants
Lesion Location Hand	19 Participants n=24 Participants
Lesion Location Leg	42 Participants n=24 Participants
Lesion Location Upper Torso	9 Participants n=24 Participants

PRIMARY outcome

Timeframe: within 1 hour after samples are taken

Positive by both the CL Detect™ Rapid Test and microscopy of an index lesion smear for amastigotes.

Outcome measures

Outcome measures
Measure	CL Detect Rapid Test on Skin Ulcers n=150 Participants Ulcerated skin lesions will be evaluated for Leishmaniasis using the CL Detect Rapid Test vs microscopy.
True Positive	0 samples

PRIMARY outcome

Timeframe: within 1 hour after samples are taken

Positive by the CL Detect™ Rapid Test but negative for Microscopy

Outcome measures

Outcome measures
Measure	CL Detect Rapid Test on Skin Ulcers n=150 Participants Ulcerated skin lesions will be evaluated for Leishmaniasis using the CL Detect Rapid Test vs microscopy.
False Positive	6 samples Interval 1.5 to 8.5

PRIMARY outcome

Timeframe: within 1 hour after samples are taken

Negative by both the CL Detect™ Rapid Test device and Microscopy

Outcome measures

Outcome measures
Measure	CL Detect Rapid Test on Skin Ulcers n=150 Participants Ulcerated skin lesions will be evaluated for Leishmaniasis using the CL Detect Rapid Test vs microscopy.
True Negative	144 samples

PRIMARY outcome

Timeframe: within 1 hour after samples are taken

Negative by the CL Detect™ Rapid Test but positive for Microscopy

Outcome measures

Outcome measures
Measure	CL Detect Rapid Test on Skin Ulcers n=150 Participants Ulcerated skin lesions will be evaluated for Leishmaniasis using the CL Detect Rapid Test vs microscopy.
False Negative	0 samples

PRIMARY outcome

Timeframe: within 1 hour after samples are taken

Negative Specificity was calculated as the number of true negatives divided by the sum of the number of true negatives plus the number of false positives.

Outcome measures

Outcome measures
Measure	CL Detect Rapid Test on Skin Ulcers n=150 Participants Ulcerated skin lesions will be evaluated for Leishmaniasis using the CL Detect Rapid Test vs microscopy.
Specificity	96.0 Percentage of samples Interval 91.5 to 98.5

PRIMARY outcome

Timeframe: within 1 hour after samples are taken

Population: a Specificity = the number of true negatives divided by the sum of the number of true negatives plus the number of false positives. b 2-sided exact binomial 95% CI. c False positive rate (α, type 1 error, calculated as 1-specificity).

False positive rate (type 1 error, calculated as 1-specificity)

Outcome measures

Outcome measures
Measure	CL Detect Rapid Test on Skin Ulcers n=150 Participants Ulcerated skin lesions will be evaluated for Leishmaniasis using the CL Detect Rapid Test vs microscopy.
False Positive Rate	4.0 Percentage of samples Interval 1.5 to 8.5

Adverse Events

Evaluation the CL Detect Rapid Test on Skin Ulcers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Giselle Singer

Mount Sinai School of Medicine

Phone: 212-241-3288

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place