Impact of Combined Azithromycin and Ivermectin Mass Drug Administration for Yaws and Scabies - Impact on Impetigo and Skin Microbiology
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,291
- 试验地点
- 1
- 主要终点
- Impetigo Prevalence at 12 Months
研究概览
简要总结
This is an open-label prospective community intervention trial to assess the impact of community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws bacterial skin infections.
Communities will be randomised to receive standard treatment for both yaws and scabies either in parallel (site 1) or in sequence (site 2).
Treatment of yaws:
Single dose of Azithromycin (30mg/kg, max 2G).
Treatment of scabies:
Either an oral dose of Ivermectin (200μg/kg) or permethrin cream for those with a contraindication to Ivermectin (WT<15kg, pregnant or breastfeeding women) given in 2 doses 7-14 days apart.
Investigators will complete a clinical and microbiological assessment of bacterial skin disease at baseline and at 12 months to assess the impact of treatment on the prevalence of bacterial infection and the emergence of antimicrobial resistance.
Primary Outcome
- Difference in the change in prevalence of impetigo between baseline and 12- months between the parallel and the sequential treatment arms.
Secondary Outcomes 2. Change in the proportion of swab samples from which S. pyogenes is cultured between baseline and follow-up in the two arms 3. The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All community members are able to be included in the study.
排除标准
- •Allergy to any of the components of the allocated drug regimen
研究组 & 干预措施
Parallel Treatment
Site 1- Parallel Treatment Arm Single dose azithromycin (for yaws) and Ivermectin/Permethrin (for scabies) will be offered on D1. A second dose of Ivermectin/Permethrin will be offered 7-14 days later.
干预措施: Ivermectin (Drug)
Parallel Treatment
Site 1- Parallel Treatment Arm Single dose azithromycin (for yaws) and Ivermectin/Permethrin (for scabies) will be offered on D1. A second dose of Ivermectin/Permethrin will be offered 7-14 days later.
干预措施: Azithromycin (Drug)
Parallel Treatment
Site 1- Parallel Treatment Arm Single dose azithromycin (for yaws) and Ivermectin/Permethrin (for scabies) will be offered on D1. A second dose of Ivermectin/Permethrin will be offered 7-14 days later.
干预措施: Permethrin (Drug)
Sequential Treatment
Site 2- Serial Treatment Arm Ivermectin/Permethrin (for scabies) will be offered on D1 with a second dose of Ivermectin/Permethrin offered 7-14 days later..
Single dose azithromycin (for yaws) will be offered at the twelve month follow-up visit.
干预措施: Ivermectin (Drug)
Sequential Treatment
Site 2- Serial Treatment Arm Ivermectin/Permethrin (for scabies) will be offered on D1 with a second dose of Ivermectin/Permethrin offered 7-14 days later..
Single dose azithromycin (for yaws) will be offered at the twelve month follow-up visit.
干预措施: Azithromycin (Drug)
Sequential Treatment
Site 2- Serial Treatment Arm Ivermectin/Permethrin (for scabies) will be offered on D1 with a second dose of Ivermectin/Permethrin offered 7-14 days later..
Single dose azithromycin (for yaws) will be offered at the twelve month follow-up visit.
干预措施: Permethrin (Drug)
结局指标
主要结局
Impetigo Prevalence at 12 Months
时间窗: Baseline and 12 months
Change in prevalence of impetigo between baseline and 12-months
次要结局
- Antimicrobial Resistance in Culture Isolates(12 Months)
- Group A Streptococcus at 12 Months(12 Months)