Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

London School of Hygiene and Tropical Medicine583 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

583

Conditions

Yaws

Interventions

Eligibility

Sex: MALEMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 6 to 16 years * Clinical lesion consistent with primary or secondary yaws -Primary ulcer or papilloma * Dually-Positive Chembio DPP Syphilis Screen \& Confirm * Informed Consent and Assent (for children 12-16 years) Exclusion Criteria: 1. Known allergy to azithromycin or macrolides. 2. Treatment with long-acting penicillin or alternative antibiotic with activity against T. pallidum within the last 3 months (ceftriaxone, azithromycin or doxycycline, amoxicillin). 3. Patients with current treatment with any drugs likely to interact with the study medication. 4. Patients who are unable to take oral medication or having gastrointestinal disease likely to interfere with drug absorption. 5. Patients who may not be able to comply with the requirements of the study protocol including follow up visits. 6. Patients who are not willing to give informed consent (patient and/or parent/legal representative), or who withdraw consent.

Locations (7)

School Based Recruitment

Ayensuanor District, Eastern Region, Ghana

School Based Recruitment

Upper West Akyem, Eastern Region, Ghana

School Based Recruitment

West Akyem District, Eastern Region, Ghana

School Based Recruitment

Nkwanta North District, Volta Region, Ghana

Community Based Recruitment

Karkar District, Madang Province, Papua New Guinea

Community Based Recruitment

Kavieng Subdistrict, New Ireland Province, Papua New Guinea

London School of Hygiene and Tropical Medicine

London, United Kingdom

Outcomes

Primary Outcomes

Number of Participants With Clinical and Serological Cure

Clinical resolution of skin lesion at 4 weeks and at least four-fold decline in Rapid Plasma Reagin titre or seroreversion at 6-month (compared to baseline) in T.pallidum subsp. pertenue Polymerase Chain Reaction-confirmed subjects with yaws.

Time frame: 6 Months

Secondary Outcomes

Number of Participants With Clinical and Serological Cure in Latent Yaws

Time frame: 6 Months

Number of Participants With Adverse Events

To compare the incidences and relative risk of all Adverse Events (AEs), including treatment-related AEs, Serious Adverse Events (SAEs) and grade 3-4 toxicity in patients treated with AZT20 and AZT30 regimens

Time frame: 6 months