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临床试验/NCT06819449
NCT06819449招募中不适用

Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients and Its Relation to Multiple Drug Therapy: Randomized Clinical Trial

South Valley University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Treatment of leprosy

研究概览

简要总结

Mycobacterium leprae is a slow-growing bacillus that causes leprosy. the infection may take two to ten years to incubate. While the exact mechanism of infection transmission is unknown, direct bacillus absorption through the nasal or respiratory mucosa and aerosolized nasal secretions are the most common theories. The bacteria is subsequently transported by the bloodstream to the peripheral nerves, where it can result in tissue damage from painless burns and ulcers as well as irreparable nerve damage that results in a loss of protective feeling.

详细描述

One of the most common host cells that mycobacteria encounter is macrophages. The process of monocyte-derived macrophages phagocytosing M. leprae is controlled by protein kinase and can be facilitated by complement receptors CR1 (CD35), CR3 (CD11b/CD18), and CR4 (CD11c/CD18). A Th2 cytokine profile appears to be correlated with nonreactivity to M.Leprea.

The Ridley-Jopling classification (1962) divides leprosy into six forms: Tuberculoid (TT), Borderline Tuberculoid (BT), Borderline-borderline Mid-borderline (BB), Borderline-Lepromatous (BL), Subpolar Lepromatous (LLs), and Polar Lepromatous (LLp). These categories are based on clinical, histopathological, and immunological criteria. According to WHO, leprosy is classified into two groups: the paucibacillary (PB) and multibacillary (MB) types, to aid in treatment.

Leprosy is treated as an outpatient procedure using WHO-standardized regimens from 1982, which essentially consist of three first-line medications: clofazimine, rifampicin, and dapsone. This relationship is referred to as polychemotherapy, or MDT (PCT). With minimal bactericidal activity, sulfone (diaminodiphenyl sulfone, or DDS), commonly referred to as dapsone, primarily acts as a bacteriostatic agent.

It most likely functions as an antagonist of para- aminobenzoic acid (PABA), preventing M. leprae from using it to synthesize folic acid. It is well-tolerated and has a number of adverse effects, most of which do not require stopping treatment.

The primary bactericidal effect of rifampicin (RMP), a semi-synthetic derivative of rifamycin B, is observed. It functions by preventing the RNA-polymerase enzyme in the bacillus from growing. RMP has been used to treat leprosy since 1963. Most of the bacilli become non-viable after a few days of therapy, and its use is crucial in all clinical types of leprosy. Clofazimine (CLF) is an iminophenazine dye . It has a mild bactericidal action, acting slowly on M. leprae and destroying 99% of the bacteria in approximately five months. Its efficacy is similar to DDS. CLF has an important anti-inflammatory action.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both sexes with positive slit skin smear for m.leprae .

排除标准

  • Contraindications to Multi drug therapy :
  • Patients with hypersensitivity to sulfa .
  • Patients with hypersensitivity to clofazimine or rifampcin.
  • pregnant or lactating women.

研究组 & 干预措施

Group A: Leprosy Patients

Active Comparator

About 40 patients suffering from Leprosy and will treated by Multi drug therapy as ( dapsone _ clofazimine _ rifampcin) then to assess the role of Rab 32 gene.by taking Two millimetres of venous blood from each participant At the end of third month therapy.

干预措施: Dapsone (Drug)

Group B: Healthy People

Active Comparator

About 10 Healthy People. no drugs used and then to assess the role of Rab 32 gene.by taking Two millimetres of venous blood from each participant

干预措施: Dapsone (Drug)

结局指标

主要结局

Treatment of leprosy

时间窗: 6 Months

About 40 of Participants With Treatment-Related Adverse Events as Assessed by measuring the of Rab 32 gene ( Rs2275606 ) polymorphism using real time PCR for Evaluation of the multi drug therapy on Leprotic Patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lydia Atef Nassief

Resident of Dermatology , venereology and andrology at Faculty of medicine

South Valley University

研究点 (1)

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