A Pharmacokinetic and Pharmacodynamic Evaluation of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole
研究概览
简要总结
This is a Pharmacokinetic and Pharmacodynamic study evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Individuals will be randomised to receive Azithromycin alone, IDA or combination therapy. Clinical and biochemical monitoring for safety will be undertaken. Drug levels will be measured in each of the three arms to assess whether combination therapy significantly alters drug levels.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult aged 18-65
- •Able to give informed consent
排除标准
- •Known chronic illness
- •Hb <7 at baseline
- •Liver function or Creatinine * 1.5 Upper Limit of Normal
- •Urinary tract infection at baseline
- •Pregnancy (female participants only)
- •Routine medications which interact with study drugs
- •Lactose/Gluten intolerance
- •Permanent disability impeding study participation
研究组 & 干预措施
Azithromycin for Yaws
Patients will receive standard treatment for yaws alone
干预措施: Azithromycin (Drug)
IDA for Lymphatic Filariasis
Patients will receive standard IDA (Ivermectin & Diethylcarbamazine & Albendazole) treatment for Lymphatic Filariasis alone
干预措施: Albendazole (Drug)
IDA for Lymphatic Filariasis
Patients will receive standard IDA (Ivermectin & Diethylcarbamazine & Albendazole) treatment for Lymphatic Filariasis alone
干预措施: Ivermectin (Drug)
IDA for Lymphatic Filariasis
Patients will receive standard IDA (Ivermectin & Diethylcarbamazine & Albendazole) treatment for Lymphatic Filariasis alone
干预措施: Diethylcarbamazine (Drug)
Combination Therapy of Azithromycin for Yaws and IDA for LF
Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.
干预措施: Azithromycin (Drug)
Combination Therapy of Azithromycin for Yaws and IDA for LF
Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.
干预措施: Albendazole (Drug)
Combination Therapy of Azithromycin for Yaws and IDA for LF
Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.
干预措施: Ivermectin (Drug)
Combination Therapy of Azithromycin for Yaws and IDA for LF
Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.
干预措施: Diethylcarbamazine (Drug)
结局指标
主要结局
Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole
时间窗: 4 Days
Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Four days)
研究者
Oriol Mitja
Associate Professor
Lihir Medical Centre