Field validation of Leish-LAMP detection kit for diagnosis of Kala-Azar (KA) and Post Kala-azar Dermal Leishmaniasis (PKDL) in endemic zone

Extramural project of RMRIMS ICMR0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年11月21日

试验速览

暂无简介。

•1. Male or female patients aged 5-65 years
•2. Post kala azar dermal leishmaniasis (PKDL), parasitologically confirmed (amastigotes in slit-skin or snip skin smears and/or skin biopsies)
•3. Macules, nodules and papules or plaques as clinical signs consistent with post Kala-azar dermal Leishmaniasis

•1. Females not willing for contraception.
•2. Patients not willing to participate.
•3. Thrombocyte count <100 x 109/l
•4. Leukocyte count <2.5 x 109/l
•5. Hemoglobin < 8.0 g/100 ml
•6. ASAT, ALAT, AP >3 times upper limit of normal range
•7. Bilirubin >2 times upper limit of normal range
•8. HbsAg, HCV and HIV positive
•9. Serum creatinine or BUN >1.5 times upper limit of normal range
•10. Hypersensitivity to miltefosine, paromomycin or inactive ingredients of miltefosine

发起方

Extramural project of RMRIMS ICMR