Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

Summary

The study will be a single blinded, randomized, controlled open label non-inferiority phase III, trial with two parallel groups, conducted in Ghana and Papua New Guinea (PNG). The ultimate goal is to establish if a 20mg/kg dose of azithromycin is as effective as a 30mg/kg dose in the treatment of yaws. Approximately 600 clinically and serologically diagnosed yaws patients will be included in the study. Patients will be randomized to receive treatment with the two antibiotic regimens as follow: (i) Regimen I (AZT20): Single oral dose of 20 mg/kg azithromycin (ii) Regimen II (AZT30): Single oral dose of 30 mg/kg azithromycin. The follow-up period of patients will be 6 months. Assessments before, during and after the antibiotic treatment will include full medical history, clinical assessment of the lesion and, laboratory investigations. The primary efficacy parameters are healing of the lesion at 4 weeks and a four-fold decline in RPR titre at 6 months after start of treatment.

Conditions

• Yaws

Interventions

DRUG

Azithromycin

Comparison of two different dosing strategies for the treatment of yaws

Sponsors & Collaborators

• World Health Organization

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• Kwame Nkrumah University of Science and Technology

  collaborator OTHER

• Barcelona Institute for Global Health

  collaborator OTHER

• Papua New Guinea Institute of Medical Research

  collaborator OTHER_GOV

• Ghana Health Services

  collaborator OTHER_GOV

• Noguchi Memorial Institute for Medical Research

  collaborator OTHER

• Papua New Guinea National Department of Health

  collaborator UNKNOWN

• University of Health and Allied Sciences

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• David Mabey · London School of Hygiene and Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

16 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• Ghana
• Papua New Guinea
• United Kingdom

Study Locations