OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- MIltefosine plasma concentrations - Time of maximum concentration (Tmax)
研究概览
简要总结
While there are indications that 28 days of miltefosine is not sufficient for treating CL by L. aethiopica, a better understanding of what happens in terms of parasite clearance and drug dosing is lacking. In this study, longitudinal measurements of parasite and drug concentrations during treatment are done to monitor parasite kinetics as well as pharmacokinetics. This data will be crucial to provide more information on duration and dosing of miltefosine in CL patients globally, and in Ethiopia and pediatric patients in particular.
详细描述
In this project, parasite dynamics and miltefosine pharmacokinetics in the skin and blood during routine durations of miltefosine treatment (4-8 weeks) are studied with the aim to provide evidence to optimize miltefosine dosing for treatment of CL. By also studying these factors in children who get allometric miltefosine dosing, data which can be used to adapt the current allometric dosing scheme specifically to children with CL will be produced. Exploratory objectives will look into searching for more objective outcome assessment measures, resistance, helminth infection and nutritional status as potential factors affecting treatment response.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical or parasitological (microscopy or PCR) confirmation of leishmaniasis
- •Clinical decision to start miltefosine treatment as systemic treatment
- •In case of females of child-bearing age: willing to take contraceptive for 6 months (parenteral or IUD or implant)
- •Willing and able to provide informed consent
- •Willing to be hospitalized for the duration of treatment
排除标准
- •Currently on treatment or having received modern treatment for leishmaniasis in the last 3 months
- •Pregnant (pregnancy test at D0) or breastfeeding
- •Unlikely to come for follow-up visits
- •Abnormal lab values Hemoglobin <5.0g/100mL Platelets <50 x 10^9/L White blood count <1 x 10^9/L ASAT/ALAT >3x upper normal range Creatinine above the normal limit
研究组 & 干预措施
Non-allometric dosing
40 patients who will not use allometric dosing will be included
miltefosine will be given based on weight: 30-45 kg: 100mg miltefosine per day >45 kg: 150mg miltefosine per day
干预措施: Miltefosine (Drug)
allometric dosing (weight below 30 kg)
40 patients who weigh less than 30kg and therefore get allometric dosing will be recruited.
Dosing is given based on weight, height, and sex, according to Dorlo et al 2012
干预措施: Miltefosine (Drug)
结局指标
主要结局
MIltefosine plasma concentrations - Time of maximum concentration (Tmax)
时间窗: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180
Determined by LC-MS/MS, stratified by whether patients received allometric dosing or not.
Miltefosine plasma concentrations - Maximum plasma concentration (Cmax)
时间窗: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180
Determined by LC-MS/MS, stratified by whether patients received allometric dosing or not.
Miltefosine plasma concentrations - Area under the plasma concentration versus time curve (AUC)
时间窗: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180
Determined by LC-MS/MS, miltefosine pharmacokinetics are assessed through calculation of the area under the plasma concentration-time curve from start of treatment until end of treatment (AUC0-EoT), stratified by whether patients received allometric dosing or not.
次要结局
- Adapted allometric dosing scheme specifically for children with CL(Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180)
- Parasite kinetics in blood and skin(Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180)
- Treatment outcomes of patients on miltefosine treatment(Day 28, day 90 and day 180)
- Assess safety of miltefosine(Day 28)