Trial Outcomes & Findings for Evaluation of a LAMP Assay for T. Pallidum. Pertenue (NCT NCT04753788)

Last Updated: 2025-03-24

Results Overview

A case of Yaws Positive for T.pallidum DNA by PCR that is also positive by LAMP

Recruitment status

COMPLETED

Target enrollment

563 participants

Primary outcome timeframe

15 Months

Results posted on

2025-03-24

Participant milestones
Measure	Suspected Yaws Cases Individuals with a lesion clinically suspected to be yaws and with evidence of positive treponemal and non-treponemal serology as assessed by point of care lateral flow tests (DPP Syphilis Screen and Confirm, Chembio) PCR: qPCR for T.pallidum LAMP: LAMP assay for T.pallidum
Overall Study STARTED	563
Overall Study COMPLETED	525
Overall Study NOT COMPLETED	38

Withdrawal data not reported

Evaluation of a LAMP Assay for T. Pallidum. Pertenue

Baseline characteristics by cohort
Measure	Suspected Yaws Cases n=525 Participants Individuals with a lesion clinically suspected to be yaws and with evidence of positive treponemal and non-treponemal serology as assessed by point of care lateral flow tests (DPP Syphilis Screen and Confirm, Chembio) PCR: qPCR for T.pallidum LAMP: LAMP assay for T.pallidum
Age, Categorical <=18 years	525 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	149 Participants n=5 Participants
Sex: Female, Male Male	376 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	525 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Cameroon	20 participants n=5 Participants
Region of Enrollment Côte D'Ivoire	93 participants n=5 Participants
Region of Enrollment Ghana	408 participants n=5 Participants
Region of Enrollment Congo	4 participants n=5 Participants

Timeframe: 15 Months

A case of Yaws Positive for T.pallidum DNA by PCR that is also positive by LAMP

Outcome measures
Measure	Serologically Confirmed Yaws n=525 Participants Positive serological test for yaws
Sensitivity of LAMP vs qpCR	63.2 Percent Interval 60.6 to 70.9

Timeframe: 15 Months

Sample negative by qPCR for T.pallidum that is also negative by LAMP

Outcome measures
Measure	Serologically Confirmed Yaws n=525 Participants Positive serological test for yaws
Specificity of LAMP for Yaws	67.1 Percent Interval 61.6 to 72.8

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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