NCT04753788

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
563

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 24, 2025

Completed
Last Updated

March 24, 2025

Status Verified

October 1, 2024

Enrollment Period

2.5 years

First QC Date

February 9, 2021

Results QC Date

April 9, 2024

Last Update Submit

March 4, 2025

Conditions

Yaws

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of LAMP vs qpCR

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

    15 Months

  • Specificity of LAMP for Yaws

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

    15 Months

Study Arms (1)

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: PCRDiagnostic Test: LAMP

Interventions

PCRDIAGNOSTIC_TEST

qPCR for T.pallidum

Suspected Yaws Cases
LAMPDIAGNOSTIC_TEST

LAMP assay for T.pallidum

Suspected Yaws Cases

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Pasteur

Yaoundé, Cameroon

Location

Institut Pasteur

Abidjan, Côte d’Ivoire

Location

Noguchi Memorial Institute of Medical Research

Accra, Ghana

Location

Related Publications (1)

  • Handley BL, Gonzalez-Beiras C, Tchatchouang S, Basing LA, Hugues KA, Bakheit M, Becherer L, Ries C, Njih Tabah E, Crucitti T, Borst N, Luert S, Frischmann S, Haerpfer T, Landmann E, Amanor I, Sylla A, Kouame-Sina MS, Ndzomo-Ngono JP, Tano A, Arhinful D, Awondo P, Ngazoa Kakou S, Eyangoh S, Addo KK, Harding-Esch EM, Knauf S, Mitja O, Marks M. LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification - protocol for a cross-sectional, observational, diagnostic accuracy study. BMJ Open. 2022 Mar 29;12(3):e058605. doi: 10.1136/bmjopen-2021-058605.

    PMID: 35351731DERIVED

MeSH Terms

Conditions

Yaws

Condition Hierarchy (Ancestors)

Treponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, BacterialSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Professor Michael Marks
Organization
LSHTM
michael.marks@lshtm.ac.uk
+44020 7636 8636

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 15, 2021

Study Start

March 15, 2021

Primary Completion

September 23, 2023

Study Completion

September 30, 2024

Last Updated

March 24, 2025

Results First Posted

March 24, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Locations

CÔ(1)GH(1)CA(1)