Field validation of Leish-LAMP detection kit for diagnosis of Kala-Azar (KA) and Post Kala-azar Dermal Leishmaniasis (PKDL) in endemic zone
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 448
- 试验地点
- 1
- 主要终点
- The mentioned sample size (448) will be collected for our study
研究概览
简要总结
Post-kala-azar dermal Leishmaniasis (PKDL) is a complication of Kala-Azar (KA), characterized by macular, maculopapular, and nodular rashes in a patient who has recovered from KA. In the Indian subcontinent, PKDL is reported in 10–15% of patients treated for KA, usually after an interval of a few months to years. Diagnosis of KA and PKDL by microscopy needs an invasive/risky sample (bone marrow aspirate, splenic aspirate, tissue biopsy), culture test is tedious and time consuming with low sensitivity while RT-PCR is costly, and therefore these tests are not applicable at Community Health Centre (CHC) levels. Immunologic strip test (rK39 test) is inconclusive for KA relapse and PKDL cases due to presence of antibodies after KA. Also, immunological rK39 strip tests cannot be used for assessment of cure. Loop-mediated isothermal amplification (LAMP) assay is a novel molecular diagnostic method to amplify DNA with rapidity and high specificity under isothermal conditions. The LAMP assay is at the forefront in the search for innovative diagnostics for rapid and specific amplification of target DNA under isothermal conditions. Shorter reaction time with visual judgment of positivity without requiring sophisticated equipment makes it an attractive diagnostic method for field application. This will be the first Indian LAMP assay kit for the diagnosis of KA and PKDL. There is a dire need of such a ‘Make in India’ molecular diagnostic kit for the success of KA elimination program. Leish-LAMP detection kit may be used in India, Nepal and Bangladesh as the same L. donovani parasite is responsible for Leishmaniasis in these countries. Leish-LAMP assay can be performed with finger prick blood sample on filter paper, also known as Dried blood spot (DBS).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 5.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged 5-65 years
- •Post kala azar dermal leishmaniasis (PKDL), parasitologically confirmed (amastigotes in slit-skin or snip skin smears and/or skin biopsies)
- •Macules, nodules and papules or plaques as clinical signs consistent with post Kala-azar dermal Leishmaniasis.
排除标准
- •Females not willing for contraception.
- •Patients not willing to participate.
- •Thrombocyte count <100 x 109/l
- •Leukocyte count <2.5 x 109/l
- •Hemoglobin < 8.0 g/100 ml
- •ASAT, ALAT, AP >3 times upper limit of normal range
- •Bilirubin >2 times upper limit of normal range
- •HbsAg, HCV and HIV positive
- •Serum creatinine or BUN >1.5 times upper limit of normal range
- •Hypersensitivity to miltefosine, paromomycin or inactive ingredients of miltefosine.
结局指标
主要结局
The mentioned sample size (448) will be collected for our study
时间窗: Period which may be needed for collecting the samples: 8 months
次要结局
- The diagnostic and prognostic utility of Leish-LAMP assay kits will be validated on the basis of primary outcomes subjects(Period which may be needed for analysis the data: 4 months)