Comparison of Two Different Doses of Azithromycin for Treatment of Yaws
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborators:
Barcelona Institute for Global Health Centers for Disease Control and Prevention Ghana Health Services Kwame Nkrumah University of Science and Technology Noguchi Memorial Institute for Medical Research Papua New Guinea Institute of Medical Research Papua New Guinea National Department of Health University of Health and Allied Sciences, Ho, Volta Region, Ghana World Health Organization