LILAC - TB : Lowering InterLeukin-1 Receptor Antagonist Concentrations After TB Treatment Onset : a Proof of Concept Study in Cambodia and Ivory Coast (ANRS 12394)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evolution of the plasma concentration of IL-1Ra between baseline (initiation of TB treatment) and Week 2
研究概览
简要总结
Despite marked improvements in the diagnosis of tuberculosis there are difficulties in diagnosing and monitoring treatment outcome among TB patients. The use of immunological biomarkers alone or in combination with other clinical parameters could predict early the response to TB treatment. The aim of this study is to demonstrate that the IL-1 receptor antagonist (IL-1Ra) concentrations significantly decrease within two weeks following TB treatment initiation in adults with active documented TB.
详细描述
The HIV/AIDS epidemic and Tuberculosis (TB) remain important challenges for global public health and are strongly linked. Despite marked improvements in the diagnosis of tuberculosis, there are difficulties in diagnosing and monitoring treatment outcome among TB patients. The use of immunological biomarkers alone or in combination with other clinical parameters could better predict the response to TB treatment. The aim of this study is to demonstrate that the IL-1 receptor antagonist (IL-1Ra) concentrations significantly decrease within two weeks following TB treatment initiation in adults with active documented TB. This is a proof-of-concept study, among 100 patients (50 HIV positive and 50 HIV negative) with documented active TB, in Cambodge and Côte d'Ivoire. Patients recruited for this study will receive the standard TB treatment per their respective national treatment guidelines. Plasma samples will be collected at baseline (initiation of TB treatment), weeks 1, 2, 4 and 8 to measure IL-1Ra, sCD163 and IP-10.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Evidence of TB, with: positive Xpert MTB/RIF
- •For HIV infected patients:
- •ART-naïve
- •Regardless of CD4 cell counts
- •Written informed consent
- •Willingness to be followed up in the study clinics for 6 months after inclusion
排除标准
- •Mycobacterium tuberculosis strain resistant to rifampin with Xpert MTB/RIF
- •Ongoing TB treatment
- •Overt evidence of other ongoing opportunistic infections
- •Pregnant or breastfeeding women
- •Karnofsky score ≤ 30
- •Person unable to understand the study
- •Person currently participating in clinical trial
- •Females on oestroprogestative and progestative hormonal contraception
结局指标
主要结局
Evolution of the plasma concentration of IL-1Ra between baseline (initiation of TB treatment) and Week 2
时间窗: 2 weeks
To measure plasma concentrations of IL - 1Ra among TB patients after two weeks of TB treatment
次要结局
- Evolution of the plasma concentration of IL-1Ra between baseline (initation of TB treatment) and weeks 1, 2, 4 and 8(8 weeks)
- Evolution of the concentration of sCD163 between baseline (initiation of TB treatment) and weeks 1, 2, 4 and 8(8 weeks)
- Evolution of the plasma concentration of IP-10 between baseline (initiation of TB treatment) and weeks 1, 2, 4 and 8(8 weeks)
- Impact of the occurrence of events on the evolution of biomarkers from baseline (initiation of TB treatment) to the end of treatment (Week 24)(24 weeks)