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Repurposing Clinically Approved Drugs for Yaws with an Insight Into the Cutaneous Ulcer Disease Syndrome (Trep-AByaws)

NCT05764876 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2025-01-09

No results posted yet for this study

Summary

The goal of this clinical trial is to test the non inferiority of linezolid compared with azithromycin as a treatment for yaws . The main questions it aims to answer are: can linezolid cure active yaws, and can linezolid cure latent yaws. Participants with serologically confirmed yaws will be randomized to receive linezolid (experimental) or azithromycin (control group) treatment and followed up to assess clinical resolution.

Conditions

  • Yaws
  • Cutaneous Ulcer

Interventions

DRUG

Linezolid Oral Tablet

Oral tablet of linezolid 10mg/kg every 8 hours for 7 days.

DRUG

Azithromycin Oral Tablet

Oral tablet of azithromycin 30mg/kg maximum 2gr single dose.

Sponsors & Collaborators

  • National Department of Health, Papua New Guinea

    collaborator UNKNOWN

  • School of Medicine and Health Sciences, University of Papua New Guinea

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Camila Beiras · Fundació Lluita contra les Infeccions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2024-06-20
Completion
2024-12-01

Countries

  • Papua New Guinea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05764876 on ClinicalTrials.gov