Safety of the Co-administration of Azithromycin, Albendazole and Ivermectin Versus Standard Treatment Regimens During Mass Drug Administration (MDA) in Ethiopia: a Cluster-randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13,511
- 试验地点
- 1
- 主要终点
- Self Reported Adverse Event
研究概览
简要总结
Cluster-randomised trial comparing co-administration of Azithromycin/Ivermectin/Albendazole with separate administration of Azithromycin and Ivermectin/Albendazole.
The study will be conducted in Beneshangul-Gumuz region, Ethiopia. Within this district, a study group of 8,000 people (in approximately 40 clusters) will receive the azithromycin, ivermectin & albendazole at a single time. A control group of 8,000 people (in approximately 40 clusters) within the same district will receive the current MDA treatment schedule beginning with Ivermectin/Albendazole followed two weeks later with azithromycin. All drug dosing will be in line with standard FMOH and WHO Guidelines for MDA for trachoma and lymphatic filariasis.
The study will randomly sort subdistrict communities (Gotes) into the trial arm and the control arm. The study will compare the number of adverse events (AEs) and severe adverse events (SAEs) between the two arms to determine if co-administration is not inferior to the standard treatment. The primary outcome will be to demonstrate the safety of the triple-drug administration as measured by incidence of AEs/SAEs following the MDA.
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
- •Residing in the community for at least three months;
- •Eligible to receive all three agents according to standard MDA criteria
排除标准
- •Not eligible to receive one or more drugs according to standard MDA criteria;
- •Less than 5 years of age (not eligible for ivermectin)**
- •Pregnant women (azithromycin only, not eligible for albendazole and ivermectin)
- •Lactating women (Only administered azithromycin and albendazole, not eligible for ivermectin)**
- •History of allergies to the drugs being studied (azithromycin, ivermectin, albendazole)
- •Residents who cannot swallow tablets
- •Note that patients that are not eligible for IVM, will receive azithromycin and albendazole. Patients that receive azithromycin and albendazole will be followed up through the same procedure as the triple drug therapy to try to track any AEs attributed to the two drug combination.
研究组 & 干预措施
Separate Administration
Standard administration of Albendazole/Ivermectin separated from administration of azithromycin
干预措施: Administration of Albendazole on Day 1 (Drug)
Separate Administration
Standard administration of Albendazole/Ivermectin separated from administration of azithromycin
干预措施: Administration of Ivermectin on Day 1 (Drug)
Separate Administration
Standard administration of Albendazole/Ivermectin separated from administration of azithromycin
干预措施: Administration of Azithromycin on Day 15 (Drug)
Co-administration
Combined administration of Albendazole/Ivermectin/Azithromycin at a single time point
干预措施: Administration of Albendazole on Day 1 (Drug)
Co-administration
Combined administration of Albendazole/Ivermectin/Azithromycin at a single time point
干预措施: Administration of Ivermectin on Day 1 (Drug)
Co-administration
Combined administration of Albendazole/Ivermectin/Azithromycin at a single time point
干预措施: Administration of Azithromycin on Day 1 (Drug)
结局指标
主要结局
Self Reported Adverse Event
时间窗: 1 Month
The incidence of self-reported adverse events following MDA. We will collect data on the presence of common symptoms/signs prior to drug administration. All patients will be reviewed 24-48 hours after treatment and asked to report adverse events. We will calculate the proportion of newly occurring adverse events following treatment and calculate the whether the proportion of patients experiencing an adverse event differs between study arms,
次要结局
- Community perceptions(1 month)
- Cost of Administration Drug Separately compared to Cost of Co-Administration of Drugs(1 month)