Trial Outcomes & Findings for Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia (NCT NCT01769612)

Last Updated: 2017-06-20

Results Overview

Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results. Note: only data where results for all three methods were available were included in the analysis.

Recruitment status

COMPLETED

Target enrollment

168 participants

Primary outcome timeframe

within 1 hour after taking samples

Results posted on

2017-06-20

Participant Flow

168 subjects were enrolled in the regions of Sidi Bouzid and Gafsa, Tunisia

Participant milestones

Participant milestones
Measure	CL Detect Rapid Test and Microsopy Samples Samples taken to be evaluated in the CL Detect and Microscopy assays No Intervention
Overall Study STARTED	168
Overall Study COMPLETED	168
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CL Detect Rapid Test and Microsopy Samples n=168 Participants Samples taken to be evaluated in the CL Detect and Microscopy assays No Intervention
Age, Continuous	40.2 years STANDARD_DEVIATION 15.8 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants
Race/Ethnicity, Customized North African	168 Participants n=5 Participants
Region of Enrollment Tunisia	168 participants n=5 Participants
Lesion Age	36.2 days STANDARD_DEVIATION 22.6 • n=5 Participants
Lesion Characteristics Ulcerated	168 Participants n=5 Participants
Lesion Characteristics Nobular	0 Participants n=5 Participants
Lesion Characteristics Secondary bacterial infection	74 Participants n=5 Participants
Lesion Location Abdomen	0 Participants n=5 Participants
Lesion Location Arm	55 Participants n=5 Participants
Lesion Location Back of head	1 Participants n=5 Participants
Lesion Location Face	4 Participants n=5 Participants
Lesion Location Foot	35 Participants n=5 Participants
Lesion Location Hand	14 Participants n=5 Participants
Lesion Location Leg	59 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 1 hour after taking samples

Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results. Note: only data where results for all three methods were available were included in the analysis.

Outcome measures

Outcome measures
Measure	CL Detect Rapid Test n=147 Participants Data for CL Detect Rapid Test	Microscopy n=147 Participants Data for Micrscopy	Culture n=147 Participants Data for Culture results
Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results	147 Participants	144 Participants	96 Participants

Adverse Events

CL Detect Rapid Test and Microsopy Samples

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

Afif Gen Salah, MD, PhD

Institut Pasteur of Tunis

Phone: 011-216-71-792-429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place