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NCT04753788 Clinical Trial

Evaluation of a LAMP Assay for T. Pallidum. Pertenue

Yaws Clinical Trial

— LAMP4YAWS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04753788
Other study ID # LSHTM-21633
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 15, 2021
Est. completion date May 2024

Study information
Verified date October 2023
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 600
Est. completion date May 2024
Est. primary completion date September 23, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• PCR
qPCR for T.pallidum
• LAMP
LAMP assay for T.pallidum

Locations
Country Name City State
Cameroon Centre Pasteur Yaoundé
Côte D'Ivoire Institut Pasteur Abidjan
Ghana Noguchi Memorial Institute of Medical Research Accra

Sponsors (8)
Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine 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

Countries where clinical trial is conducted

Cameroon,  Côte D'Ivoire,  Ghana, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of cases of yaws confirmed by molecular testing A clinically suspected case of yaws where T.pallidum DNA is detected by PCR or LAMP 15 Months
See also
  Status Clinical Trial Phase
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Completed NCT03664063 - PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs ) Phase 2
Completed NCT03676140 - Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs ) Phase 3
Completed NCT04453124 - An Accessible Low-cost Plant Treatment for Cutaneous Ulcers Phase 2
Completed NCT01955252 - Effect of WHO-yaws Elimination Strategy in Lihir Island, Papua New Guinea Phase 3
Active, not recruiting NCT05764876 - Repurposing Clinically Approved Drugs for Yaws With an Insight Into the Cutaneous Ulcer Disease Syndrome (Trep-AByaws) Phase 3
Completed NCT02344628 - Comparison of Two Different Doses of Azithromycin for Treatment of Yaws Phase 3
Completed NCT03683745 - Integrated Mapping of Skin-presenting Neglected Tropical Diseases in Liberia
Completed NCT02775617 - Azithromycin - Ivermectin Mass Drug Administration for Skin Disease Phase 4
Completed NCT01841203 - Dual Point-of-care Test for the Diagnosis of Yaws N/A
Completed NCT03490123 - Evaluation of an Intensive 3-round MDA Strategy Towards Yaws Eradication Phase 4