Evaluation of a LAMP Assay for T. Pallidum. Pertenue

Completed

• Conditions: Yaws
• Interventions: Diagnostic Test: PCR; Diagnostic Test: LAMP

• Registration Number: NCT04753788
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief Summary

This is a diagnostic evaluation comparing the performance of real-time PCR performed at a national reference laboratory and a LAMP assay performed at a regional hospital for the diagnosis of yaws

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-15
• Study Start: 2021-03-15
• Primary Completion: 2023-09-23
• Results First Submitted: 2024-04-09
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Results First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Results First Posted: 2025-03-24
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 563

Inclusion Criteria

• Lesion consistent with yaws
• Positive treponemal and non-treponemal antibodies assessed by the DPP Syphilis Screen and Confirm RDT

Exclusion Criteria

• Unable to give consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected Yaws Cases	PCR	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)
Suspected Yaws Cases	LAMP	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)

Primary Outcome Measures

Name	Time	Method
Sensitivity of LAMP vs qpCR	15 Months	A case of Yaws Positive for T.pallidum DNA by PCR that is also positive by LAMP
Specificity of LAMP for Yaws	15 Months	Sample negative by qPCR for T.pallidum that is also negative by LAMP

Trial Locations

Locations (3)

Noguchi Memorial Institute of Medical Research; 🇬🇭 Accra, Ghana

Centre Pasteur; 🇨🇲 Yaoundé, Cameroon

Institut Pasteur; 🇨🇮 Abidjan, Côte D'Ivoire