Evaluation of a LAMP Assay for T. Pallidum. Pertenue

NCT ID: NCT04753788

Last Updated: 2025-03-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

563 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-15

Study Completion Date

2024-09-30

Brief Summary

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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

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Conditions

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Yaws

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type DIAGNOSTIC_TEST

qPCR for T.pallidum

LAMP

Intervention Type DIAGNOSTIC_TEST

LAMP assay for T.pallidum

Interventions

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PCR

qPCR for T.pallidum

Intervention Type DIAGNOSTIC_TEST

LAMP

LAMP assay for T.pallidum

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pasteur Institute abidjan

UNKNOWN

Sponsor Role collaborator

Centre Pasteur du Cameroun

OTHER

Sponsor Role collaborator

Noguchi Memorial Institute for Medical Research

OTHER

Sponsor Role collaborator

University of Freiburg

OTHER

Sponsor Role collaborator

MAST Group - Germany

UNKNOWN

Sponsor Role collaborator

Friedrich-Loeffler-Institut

UNKNOWN

Sponsor Role collaborator

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Pasteur

Yaoundé, , Cameroon

Site Status

Institut Pasteur

Abidjan, , Côte d’Ivoire

Site Status

Noguchi Memorial Institute of Medical Research

Accra, , Ghana

Site Status

Countries

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Cameroon Côte d’Ivoire Ghana

References

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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.

Reference Type DERIVED
PMID: 35351731 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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LSHTM-21633

Identifier Type: -

Identifier Source: org_study_id

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