Application of Ultrasound Shear Wave Elastography on the Adjunct Corticosteroid Therapy on Tuberculous Lymphadenitis: a Randomized Control Trial
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
- reduction rate of paradoxical upgrading reaction
研究概览
简要总结
- To prospectively collect the radiologic data from the initial phase till the post-treatment phase of tuberculous lymphadenitis.
- To prospectively investigate the benefits of corticosteroid on reduction of paradoxical upgrading reaction in patients with tuberculous lymphadenitis based on the results of shear wave elastography.
- To investigate the potential biomarker of host immunity in response to tuberculosis and predict the development of paradoxical upgrading reaction.
详细描述
Tuberculosis remained one of the top ten leading cause of death worldwide. There were more than 10 million new diagnoses per year, and up to 1.2 million deaths caused by tuberculosis. Extra-pulmonary tuberculosis is defined as infection outside the lung. Tuberculous lymphadenitis is the most common site of extra-pulmonary tuberculosis, constituting around 30-50% of all cases. A unique manifestation with worsening of symptoms, called paradoxical upgrading reaction (PUR), may develop in 20-50% of patients with tuberculous lymphadenitis during the therapy. Common presentations of the PUR include swollen lymphadenitis with pain or rupture with pus. Patients may fail to complete the treatment and jeopardize the development of drug-resistant pathogen. Limited studies investigated the risk factors associated with the PUR. In our prior study, ultrasound shear wave elastography offers quantified values as the objective parameters to successfully predict the occurrence of PUR. In this study, we aim to investigate the effect of corticosteroid as an adjunct therapy to reduce the PUR from happening in patients with tuberculous lymphadenitis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed of tuberculous lymphadenitis.
- •The diagnosis of tuberculous lymphadenitis must qualify any of the following criteria:
- •microbiological evidence (culture or nucleic acid amplification test)
- •histology specimen featuring caseating granulomatous inflammation with acid-fast bacilli on smear, or clinical response to anti-tuberculosis therapy.
排除标准
- •Participants with age < 18 years
- •Diagnoses based on histologic report turned out to be non-tuberculosis mycobacterial infection
- •The tuberculous lymphadenitis involved was surgically removed, without available target to be monitored
- •Participant under systemic (oral or parenteral) steroid therapy.
- •Participant with active hepatitis B virus infection
- •Participant reluctant to be enrolled in the trial
研究组 & 干预措施
Adjunct corticosteroid and standard anti-tuberculosis agent
Prednisolone dosing and duration per study protocol
干预措施: Prednisolone (Drug)
Adjunct corticosteroid and standard anti-tuberculosis agent
Prednisolone dosing and duration per study protocol
干预措施: standard anti-tuberculosis agents (Drug)
Standard of care with standard anti-tuberculosis agent
standard anti-tuberculosis agent
干预措施: standard anti-tuberculosis agents (Drug)
结局指标
主要结局
reduction rate of paradoxical upgrading reaction
时间窗: up to 9 months
decreased in occurrence of unpredicted paradoxical reaction
次要结局
- tuberculosis relapse rate(up to 24 months)
- adverse events during corticosteroid therapy(up to 9 months)
- paradoxical upgrading reaction rate in low elasticity group(up to 9 months)
- hospital-anxiety scale(up to 9 months)
- hospital- depression scale(up to 9 months)
- treatment duration(up to 9 months)