A Pilot Study for Capacity Building for a Multi-centre, Randomized Trial for Treatment of Kala Azar in Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To develop capacity to evaluate newer regimens for treatment of kala azar in Bangladesh.
研究概览
简要总结
Kala azar (KA) or visceral leishmaniasis (VL) is endemic in several districts of Bangladesh with the highest incidence in Mymensingh, Pabna and Tangail districts. ICDDR,B is involved in a project for improving the surveillance of KA in Trishal, Mymensingh since 2005. Improvement of case detection is necessary for both surveillance purposes and better control. The aims of this pilot study are to assess some newer techniques for diagnosis of KA using blood and urine samples of suspected cases; and evaluate response to treatment with sodium stibogluconate to which resistance has been reported in India, considered to be a part of the same zone harboring the disease agent Leishmania donovani and transmitted by the same vector Phlebotomas argentipes (sand-fly). No data is currently available on response to sodium stibogluconate in KA patients in Bangladesh. Although a number of new drugs have been evaluated in the treatment of KA in India and Kenya, no trial has so far been conducted in Bangladesh. A team of researchers from GlaxoSmithKline (UK) had recently visited Bangladesh to evaluate if it would be possible to conduct a Phase-III clinical trial with sitamaquine. They interacted with scientists of ICDDR,B and expressed their interest to help develop ICDDR,B's capacity in order to include Bangladesh as one of the sites for the planned, multi-centre, Phase-III trial of sitamaquine; India and Nepal are two other possible sites for the trial. The aims of the proposed study are to train physicians and laboratory personnel in preparation for the future drug trial(s) on KA as well as to compare different tests for its diagnosis that might improve case detection at the field level and used for research purposes. The investigators will also examine in greater detail the different Leishmania species circulating in the area of Mymensingh and whether treatment failure and occurrence of Post Kala azar Dermal Leishmaniasis (PKDL) is associated with certain species.
详细描述
Specific Aims:
Primary objective: To develop capacity to evaluate newer regimens for treatment of kala azar in Bangladesh.
Secondary objectives:
- To evaluate novel diagnostic tests for kala azar including rK39 dipstick test in serum; KATEX in urine; and PCR (polymerase chain reaction) in blood and clinical samples.
- To evaluate response to treatment with 28 injections of SAG using PCR in blood samples and clinical samples.
- To transfer the mini-exon PCR-RFLP technique to ICDDR,B and to characterize the most prevalent Leishmania species in the area of Mymensingh and their response to standard treatment with SAG.
- We will also analyze whether certain genotypes are associated with the occurrence of PKDL and whether the mini-exon PCR is a suitable marker for monitoring the intra and interspecies genetic evolution of Leishmania species.
Research Design and Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •KA will be enrolled into the study:
- •fever for >2 weeks
- •at least one of the the following criteria- splenomegaly, darkening of the skin, and weight loss
- •a positive rK39 dipstick test.
排除标准
- •children under five years of age\
- •pregnant women
- •patients who are suffering simultaneously from any other serious illness which is unrelated to kala azar (for example, tuberculosis, cancer, etc).
结局指标
主要结局
To develop capacity to evaluate newer regimens for treatment of kala azar in Bangladesh.
时间窗: 1 year
次要结局
- To evaluate response to treatment with 28 injections of SAG(1 year)