Evaluation of a LAMP Assay for T. Pallidum. Pertenue (LAMP4YAWS)

March 12, 2024 updated by: London School of Hygiene and Tropical Medicine

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
      • Yaoundé, Cameroon
        • Centre Pasteur
  • Côte D'Ivoire
      • Abidjan, Côte D'Ivoire
        • Institut Pasteur
  • Ghana
      • Accra, Ghana
        • Noguchi Memorial Institute of Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with clinically suspected yaws lesions in Ghana, Cote d'Ivoire and Cameroon will be screened using the DPP Syphilis Screen and Confirm RDT. If positive samples will be taken for PCR and LAMP testing.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Diagnostic test: PCR
qPCR for T.pallidum
Diagnostic test: LAMP
LAMP assay for T.pallidum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cases of yaws confirmed by molecular testing
Time Frame: 15 Months
A clinically suspected case of yaws where T.pallidum DNA is detected by PCR or LAMP
15 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Actual)

September 23, 2023

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • LSHTM-21633

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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