Thalidomide in the treatment of tuberculoma: A prospective randomized open blinded endpoint (PROBE) study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- symptom resolution at 3 months after randomization
研究概览
简要总结
No randomized controlled trials (RCTs) have been conducted till date to determine the efficacy of Thalidomide in treating CNS tuberculoma. This is despite it being a clinical challenge in endemic areas. Most of these patients are on prolonged ATT, second line ATT as well as recurrent or persistent high doses of corticosteroids, with resultant side effects of the same. So, there is significant knowledge gap in treatment of CNS tuberculomas. The evidence of efficacy of Thalidomide is limited to case reports and cohorts of paediatric patients, although it equally affects adult patients as well.
Our study would be the first of its kind to explore an adjuvant therapy for better resolution of CNS tubercular lesions along with standard treatment. Our clinical trial would also help in determining the safety and efficacy of thalidomide in treating CNS tuberculoma patients. This novel treatment would also help in determining the significance of Thalidomide in resolving paradoxical lesions developing during ATT regimen. Recovery from CNS Tuberculoma is long and critical process and using an adjuvant like Thalidomide to reduce the recovery time would also make the entire process of treating CNS TB cost-effective, especially in resource-limited settings.
Therefore, our hypothesis is that Thalidomide used as an adjuvant along with ATT and corticosteroids for treatment of CNS tuberculoma would be safe and effective in resolution of CNS tuberculoma in terms of functional outcome and radiological improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients with suspected CNS Tuberculoma diagnosed clinically and radiologically who have completed their intensive phase (two months) of ATT.
- •CNS Tuberculoma causing any of the following: a.
- •Raised Intracranial pressure with or without radiological and/or clinical herniation syndromes.
- •Focal neurological deficit (loss of vision, hemiparesis, paraparesis, disabling persistent movement disorder or sensory loss) c.
- •Drug refractory seizures/ status epilepticus Patient or Legally Acceptable Representative (LAR) willing to give informed consent before study procedure.
排除标准
- •Any of the following: -Patients having associated cryptococcal meningitis.
- •Patients who are HIV positive.
- •Patients with hepatic or renal dysfunction, organ transplantation, malignancy, pregnancy and lactation.
- •Patients who are diagnosed as multi drug resistant tuberculosis (MDR-TB) and are given second line ATT for longer duration.
- •Patients having multiple myeloma or any other form of cancer and are already receiving Thalidomide treatment.
- •Concurrent participation in any other therapeutic clinical trial.
结局指标
主要结局
symptom resolution at 3 months after randomization
时间窗: symptom resolution at 3 months after randomization
次要结局
- Symptom resolution at 6 months.(Radiological resolution at 3 and 6 months.)
研究者
Deepti Vibha
All India Institute of Medical Sciences