A pilot study to examine the cure rates of oral miltefosine and sodium stibogluconate for treating Old World Cutaneous Leishmaniasis in Kandahar, Afghanistan

niversity of Oxford0 个研究点目标入组 103 人开始时间: 2018年7月10日最近更新: 2024年8月19日

适应症

试验速览

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•1. age greater than or equal to 1 to 60 years old male
•2. age greater than or equal to 1 to less than14 years for females
•3. weight greater than or equal to 10 kg
•4. presentation with amastigote positive, by Giemsa-stained smear, cutaneous lesion(s)
•5. lesions needing systemic treatment, any one of the following:
•5.1 greater than or equal to 1 lesion that is active and measuring greater than or equal to 3 cm in a patient aged greater than or equal to 5 y (even if other lesions maybe less than 3cm)
•5.2 greater than or equal to 1 lesion that is active and measuring greater than or equal to 2 cm in a child aged less than 5 y (even if other lesions maybe less than 2cm)
•5.3 are located on the ears, or fingers, or toes, or face, or near the eyes, or nose, or lips (irrespective of the size)
•5.4 greater than or equal to 1 lesion that is associated with easily palpable regional lymph nodes, irrespective of the size
•5.5 greater than or equal to 1 lesion that is over a joint, irrespective of the size
•5.6 greater than or equal to 3 lesions, irrespective of size
•5.7 lupoid or sporotrichoid lesions, irrespective of the size

•1. severe lesions requiring hospital treatment i.e. surgery and/or IV SSB (physician s decision)
•2. solitary lesion less than 2 cm in a child less than 5y or less than 3 cm in a patient aged greater than or equal to 5 y
•3. all women aged greater than or equal to 14 years
•4. pregnant or breast feeding female
•5. female intending to have a child in the next 12 months
•6. known allergy to SSB or miltefosine
•7. known serious underlying disease e.g. liver, renal, cardiac disease, HIV, tuberculosis, on systemic steroids
•8. creatinine clearance less than 30 mL/min (Cockcroft Gault, Schwartz formulae)*
•9. ALT greater than 3 x upper limit of normal (ULN)
•10. Total bilirubin greater than 1.5 x ULN
•11. Presence of an abnormal cardiac rhythm
•12. Prolonged QTc interval (Bazzet s correction) (Rijnbeek, Witsenburg et al. 2001) (Pearl 1996):
•12.1 age 5 to less than12: greater than or equal to 470 ms (females) or greater than or equal to 460 ms (males)
•12.2 age 12 to less than18: greater than or equal to 480 ms (females) or greater than or equal to 470 ms (males)
•12.3 age greater than or equal to 18: greater than or equal to 470 ms (females) or greater than or equal to 450 ms (males)

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