Evaluation of the effect of standard corticosteroid treatment compared to extended adjunctive corticosteroid treatment on proinflammatory cytokines in paradoxical reactions in tuberculous meningitis: A Randomized control trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in levels of cytokines TNF Alpha, IL Six , and IL Ten
研究概览
简要总结
Tuberculous meningitis is the most severe TB form, with a 20–30 percent mortality rate and neurological sequelae in up to 78 percent of survivors. Treatment response varies, with paradoxical reactions occurring in 40–60 percent of patients. PR is characterized by clinical or radiological worsening within three months of antitubercular treatment after initial stabilization. Paradoxical tuberculoma refers to new or enlarged tuberculomas post-ATT. In HIV-associated TB, TB IRIS immune reconstitution inflammatory syndrome, presents as inflammatory symptoms within three months of antiretroviral therapy , reported in 15.7 percent of cases. PR and IRIS are attributed to Mycobacterium tuberculosis antigen load and host immune response, with contributing factors including excessive inflammation, high proinflammatory cytokines, CD4 count, and genetic polymorphisms. Adjunctive corticosteroids reduce TBM mortality and are typically given for one month. Elevated TNF alpha, IL Six and IL Ten in PR patients, suggesting excessive inflammation. Extended prednisolone use may suppress these biomarkers, potentially reducing PR incidence. Further evaluation of extended corticosteroid therapy is needed to optimize TBM management and improve patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 15.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with TBM The essential criteria include presence of meningitis symptoms comprising of fever, headache and vomiting for two week or more.
- •The supportive criteria include (1) CSF cells 0.1 x 109/l or more with predominant lymphocytes, protein more than 1 gm/l, sterile bacterial and fungal culture; (2) CT or MRI scan evidences of exudates, infarctions, hydrocephalus and tuberculoma in isolation or in various combinations; (3) evidence of extra central nervous system tuberculosis and (4) response to anti-tubercular therapy.
- •Presence of essential and 3 of 4 supportive criteria will be considered highly probable and 2 supportive criteria as probable TBM.
- •Presence of AFB in CSF smear or culture, positive PCR for M.
- •tuberculosis in CSF will be considered definitive evidence of TBM.
排除标准
- •Patients with malaria, septic, fungal and carcinomatous meningitis, HIV, resistant TB, head injury, stroke, tumors, malignancy, chronic renal failure, hepatic failure, heart failure, chronic obstructive pulmonary disease, asthma, Age less than 15 years or more than 70 years, pregnancy, lactation, and those having life expectancy less than 6month due to other disease will be excluded.
结局指标
主要结局
Change in levels of cytokines TNF Alpha, IL Six , and IL Ten
时间窗: Baseline,6 Weeks & 3 months
次要结局
- Paradoxical Reaction(Death within 3month)
研究者
Prakash Chandra Pandey
Sanjay Gandhi Post Graduate Institute of Medical Sciences