Paradoxical Reactions During Anti-mycobacterial Treatment of Extrapulmonary Tuberculosis in Non Immuno-compromized Patients : Clinical, Radiological et Immunological
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Risk factors of paradoxical reaction
研究概览
简要总结
Tuberculous paradoxical reactions (PR) are immune reactions occurring during the course of antituberculous treatment and leading to a worsening of tuberculous symptoms after an initial improvement. This phenomenon has very extensively studied in HIV infected patients where it corresponds to the so called IRIS (immune reconstitution syndrome). However, it laso occurs in non immuno-compromized patients, especially those with extra-pulmonary localization of tuberculosis. The aim of the study is to look for risk factors of paradoxical reaction in non immuno-compromized patients with extra-pulmonary tuberculosis. The investigators will consider clinical, radiological and biological variables, including specific immune and genetic markers. Our secondary goals are to estimate the incidence of PR, describe their natural history; characterize the type of immune response they correspond to, and look for better diagnostic tools.The immunological characterization and the finding of predictive factors of PR, especially the genetic ones will allow a better understanding of biological mechanisms that lead to their occurrence during extra-pulmonary tuberculosis treatment. The establishment of predictive criteria could permit a better surveillance of at risk patients for a rapid treatment, or even a prevention of PR. The establishment of new diagnostic criteria at the time of PR could avoid numerous invasive diagnostic procedures, surgery and/or useless prolongation of antibiotic treatment.
详细描述
Primary objective :
Search for predictive factors of tuberculous paradoxical reaction (PR), with assessment of clinical, radiological and biological factors.
Secondary objectives :
- Descriptive study of PR : incidence, clinical and radiological presentation, clinical course ; characterization of mycobacteria strains- Search for genetic predictive factors of PR
- Characterization of the specific immune antigene response during PR et analysis of different cell subsets implicated in peripheral blood and locally- Characterization of the anti-bacterial immune response before and after antituberculous treatment
- Preliminary search for new diagnosis criteria including clinical, biological (immune and genetic) and radiological factors.Methodology : Multicentric cohort study for a total of 5 years (4 years of enrolment and one year of follow-up, with biological collection for scientific purpose
Inclusion Status of patients (determined by a validation comity at M6)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Extrapulmonary tuberculosis, with associated pulmonary localization or not
- •Treatment started less than 5 days ago
- •Negative HIV serology
- •Social insurance
- •Age >= 18- Foreseeable follow-up of at last one year
- •Signed Free Inform Consent
排除标准
- •HIV infection
- •immuno-suppressive treatment (including corticosteroids > 10 mg /d prednisone equivalent, however patients with corticotherapy could be included during the phase 2 of the study)
- •central neurological system tuberculosis and tuberculous pericarditis - pure pulmonary tuberculosis
- •multiresistant tuberculosis
- •pregnancy or breast feeding
结局指标
主要结局
Risk factors of paradoxical reaction
时间窗: at 6 months
Risk factors of paradoxical reaction : clinical, radiological immune and genetic factors
次要结局
- Incidence and natural history of paradoxical reactions(during the first 6 months)
- Immune description of paradoxical reactions(during the first 6 months)
- Preliminary study of Diagnosis factors of paradoxical reaction(during the first 6 months)
