NCT02344628

Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

Randomized Controlled Trial Comparing Efficacy of Single Dose Treatment of Yaws With 20mg/kg Versus 30mg/kg of Azithromycin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 583 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: Male
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Azithromycin	Comparison of two different dosing strategies for the treatment of yaws

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-01-26
• Last updated: 2018-10-31
• Results posted: 2018-10-03

Locations

7 sites across 3 countries: Ghana, Papua New Guinea, United Kingdom