OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Miltefosine
  Miltefosine will be prescribed by the treating physician for a minimum of 4 weeks. If treatment response is not sufficient, treatment extension could be decided by the treating physician up to 8 weeks

Первичные конечные точки

• Miltefosine plasma concentrations - Area under the plasma concentration versus time curve (AUC) [Срок оценки: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180]
• Miltefosine plasma concentrations - Maximum plasma concentration (Cmax) [Срок оценки: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180]
• MIltefosine plasma concentrations - Time of maximum concentration (Tmax) [Срок оценки: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180]

Вторичные конечные точки (4)

• Parasite kinetics in blood and skin [Срок оценки: Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42/Day 56, Day 90, Day 180]
• Adapted allometric dosing scheme specifically for children with CL [Срок оценки: 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 [Срок оценки: Day 28, day 90 and day 180]
• Assess safety of miltefosine [Срок оценки: Day 28]

Критерии участия

Критерии включения

• Clinical or parasitological (microscopy or PCR) confirmation of leishmaniasis
• Age >2
• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Ethiopia · 1 центр

• Africa Leprosy, Tuberculosis, Rehabilitation and Training (ALERT) Hospital — Addis Ababa

Идентификаторы

NCT: NCT06514560 · 1708/23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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