Airway Injury Risk Mechanisms and IL-6 (AIR-MAIL study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Compare the proportion of participants with any phenotype of lung function impairment - airflow obstruction, restriction or mixed ventilatory defect - between HIV-positive and HIV-negative TB patients at 6 months
研究概览
简要总结
The overarching goal of this proposal is to compare the burden, severity, and phenotypic presentation of post TB lung disease (PTLD), and its association with IL-6 signaling pathways, in TB patients with and without HIV. We will leverage the ongoing NIH-funded RePORT-India TB Research Consortium, a multi-site study that is already evaluating over 200 HIV-negative adults with drug-sensitive TB for longitudinal lung health assessments during and after TB treatment, along with whole blood and induced sputum biobanking for immunological testing. Through this R01 application, we propose enrolling a comparison cohort of 200 consecutive HIV-positive drug-sensitive TB patients receiving anti-retroviral therapy (ART), who will follow identical study protocols.
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|Author(s) name
Research
and Study
design
Data
collection
& Analysis
Laboratory
analysis
Interpretation
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conclusion
Preparation
of
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Review of
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Guide
and critical
revision
Final approval
of the version
to be published
Agreement to be accountable for
all aspects of
the research work
|DJ Christopher
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|Akshay Gupta
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|Balamugesh Thangakunam
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|Dr. Sanjay Gaikwad
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|Dr. Amita Gupta
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研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically (symptoms and/or chest X-ray) or microbiologically (sputum smear microscopy, GeneXpert or culture) confirmed pulmonary TB disease Has already or is planning to initiate TB treatment Laboratory confirmed HIV-positive status Currently receiving ART for at least 6 months Ability and willingness to provide informed consent.
排除标准
- •Extra-pulmonary TB case without pulmonary disease on clinical (symptoms and/or chest X-ray) or microbiological (sputum smear microscopy, GeneXpert or culture) assessment TB case with multi- or extensively-drug resistant TB Prior TB regardless of treatment duration Received TB treatment for over 7 days for current TB episode History of any chronic lung disease including COPD and asthma.
结局指标
主要结局
Compare the proportion of participants with any phenotype of lung function impairment - airflow obstruction, restriction or mixed ventilatory defect - between HIV-positive and HIV-negative TB patients at 6 months
时间窗: Compare the proportion of participants with any phenotype of lung function impairment - airflow obstruction, restriction or mixed ventilatory defect - between HIV-positive and HIV-negative TB patients at 6 months
次要结局
- Compare the proportion of participants with persistent PTLD i.e., airflow obstruction, restriction or mixed ventilatory defect at 6 and 12 months, between HIV-positive and HIV-negative TB patients(Baseline, 2 months and 6 months)
研究者
Devasahayam J Christopher
Christian Medical College, Vellore