Evaluation of a LAMP Assay for T. Pallidum. Pertenue

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

Completed

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Key information

Conditions

Yaws Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Spirochaetales Infections Treponemal Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Pasteur, Yaoundé, Cameroon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCR

Diagnostic Test

qPCR for T.pallidum

LAMP

Diagnostic Test

LAMP assay for T.pallidum

Primary outcomes

Sensitivity of LAMP vs qpCR

Time frame: 15 Months

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

Time frame: 15 Months

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

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

Centre Pasteur du Cameroun
Friedrich-Loeffler-Institut
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
MAST Group - Germany
Noguchi Memorial Institute for Medical Research
Pasteur Institute abidjan
University of Freiburg

Registry information

Official study title

Clinical Evaluation of a Loop-mediated Isothermal Amplification Test for Treponema Pallidum Pertenue: A Diagnostic Tool to Support Yaws Eradication

Acronym: LAMP4YAWS

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2024
First posted: Feb 15, 2021
Registry last updated: Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed