Randomized Controlled Trial Comparing Efficacy of Single Dose Treatment of Yaws With 20mg/kg Versus 30mg/kg of Azithromycin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 583
- 试验地点
- 3
- 主要终点
- Number of Participants With Clinical and Serological Cure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Known allergy to azithromycin or macrolides.
- •Treatment with long-acting penicillin or alternative antibiotic with activity against T. pallidum within the last 3 months (ceftriaxone, azithromycin or doxycycline, amoxicillin).
- •Patients with current treatment with any drugs likely to interact with the study medication.
- •Patients who are unable to take oral medication or having gastrointestinal disease likely to interfere with drug absorption.
- •Patients who may not be able to comply with the requirements of the study protocol including follow up visits.
- •Patients who are not willing to give informed consent (patient and/or parent/legal representative), or who withdraw consent.
研究组 & 干预措施
AZT30
Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams
干预措施: Azithromycin (Drug)
AZT20
Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams
干预措施: Azithromycin (Drug)
结局指标
主要结局
Number of Participants With Clinical and Serological Cure
时间窗: 6 Months
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.
次要结局
- Number of Participants With Clinical and Serological Cure in Latent Yaws(6 Months)
- Number of Participants With Adverse Events(6 months)