Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France - ANRS 464s FrenchTB
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Success of the anti-tuberculosis treatment
研究概览
简要总结
The French Tuberculosis Cohort is a prospective, national, multicenter, low-intervention study including subjects aged 18 years and older with tuberculosis disease for which inpatient treatment is initiated. The goal of this observational study is to follow-up and anti-tuberculosis treatment will be provided according to current French recommendations. Participants will provide sociodemographic, clinical, biological, radiological and bacteriological data at various protocol visits at 2 days, 1 and 2 weeks, 2 months, at the end of treatment, 12 and 24 months. Consenting participants will have samples collected at scheduled visits for the establishment of a biobank. This will include blood, urine, breath and hair samples. The positive mycobacterial strains will constitute a specimen bank.
详细描述
Main objectif:
To describe the sociodemographic, clinical, radiologic, and bacteriologic characteristics, as well as comorbidities and their impact on treatment outcomes and relapse rate up to 24 months after the start of anti-tuberculosis treatment in people with tuberculosis disease diagnosed in France.
Secondary objectives:
- Evaluate the effects of immunosuppression (HIV infection, organ transplantation, immunosuppressive treatments) on tuberculosis symptomatology, complications (including immune reconstitution inflammatory syndromes (IRIS), and drug interactions), treatment response and survival.
- Describe the characteristics of severe (meningeal, pericardial, miliary, etc.) or complicated forms of tuberculosis, including resistant tuberculosis, their management (treatment of resistant TB, use of anti-TNF, corticoids), their impact on treatment outcomes, relapse rates up to 24 months, sequelae and survival.
- Describe representations of the disease and its care, its impact on quality of life, and the effect of social determinants, situations of precariousness, health literacy, belonging to key populations (incarcerated, migrant and/or homeless people) as well as mental health disorders and addictions on compliance, experience of the disease, follow-up, and treatment outcomes.
- Describe the effect of new short-course tuberculosis treatments on adherence, disease experience, follow-up and treatment outcomes.
- Describe post-tuberculosis pulmonary sequelae, study their association with immunosuppression, pharmacological dosages, other comorbidities, tobacco and alcohol consumption, and measure physiological, structural and functional disorders, their impact on quality of life and survival.
- Study the potential diagnostic and prognostic value of new biomarkers in people with tuberculosis and the effect of exposure to anti-tuberculosis treatment on response to tuberculosis therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Aged ≥18 years.
- •Diagnosis of tuberculosis by microbiological or clinical means, including on the basis of a pathological examination for extrapulmonary tuberculosis leading to a Compulsory Declaration (CD) and treated for less than 8 days.
- •Have signed a voluntary, informed and written consent (at the latest on the day of inclusion and before any examination carried out as part of the research), or alternatively, consent from relatives in cases of tuberculous meningitis or other serious forms of tuberculosis with impaired consciousness or confusion, until the person is able to give their consent.
排除标准
- •Presence of significant cognitive impairment that, in the opinion of the site investigator or designated person, may affect the ability to give reliable informed consent (except in the specific case of meningeal tuberculosis).
研究组 & 干预措施
No Intervention
People starting treatment for tuberculosis disease
结局指标
主要结局
Success of the anti-tuberculosis treatment
时间窗: through treatment completion; Month 12
Probable cure: clinical and radiological improvement of tuberculosis-related symptoms in a participant who has completed treatment and never met the definition of treatment failure.
Proportion of participants with successful anti-tuberculosis treatment outcome, defined as definite or probable cure, by Month 12
时间窗: through treatment completion; Month 12
Definite cure (microbiological): negative cultures (or direct examination) of respiratory specimens on two occasions during follow-up, in the last month of treatment and on an intermediate specimen, in a participant who has completed treatment and has never met the definition of treatment failure.
次要结局
- Functional impact and repercussions of respiratory sequelae(Baseline, Month 2, completion or failure of treatment (up to 12 months))
- Early microbiological response(Month 2)
- Health literacy(Baseline, Day 3, Day 7)
- Complementary support for medical follow-up to compliance with treatment(Month 2, completion of treatment, Month 12)
- Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology(treatment completion until Month 24)
- Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology and/or hypoxaemia(treatment completion until Month 24)
- Clinical and radiological post-tuberculosis respiratory sequelae and not related to another Pulmonary pathology(Baseline, completion or failure treatment (up to 12 months))
- Adherence to tuberculosis treatment(Week 2, Month 2, completion of treatment)
- Screening for precariousness(Baseline, Day 3, Day 7, Month 2, Month 12)
- Only in case of TB meningitis(Baseline, Month 2, completion or failure of treatment (up to 12 months))
- Positive culture(Month 5)
- Tuberculosis-related death(Month 5)
- Premature treatment interruption without resumption(Month 5)
- Ongoing treatment at Month 12 due to interruption, resistance, adverse events, or initial failure(Month 12)
- Transfer or loss to follow-up(Month 5)
- All-cause mortality(Until Month 24)
- Tuberculosis relapse(Between end of treatment and Month 24)
- Functional impact and repercussions of respiratory sequelae(Baseline, Month 12, completion or failure treatment)
- Functional impact and repercussions of respiratory sequelae(Completion treatment, Month 24)
- Functional impact and repercussions of respiratory sequelae(Completion treatment (up to 12 months), Month 24)
- Functional impact and repercussions of respiratory sequelae(Baseline, week 2, Month 12, completion or failure of treatment (up to 12 months), Month 24)
- Functional impact and repercussions of respiratory sequelae(Baseline, Month 2, completion or failure of treatment, Month 24)
- Quality of life and mental health(Baseline, During anti-tuberculosis treatment up to Month 12)
- Quality of life and mental health(Baseline, Month 2, completion or failure of treatment (up to 12 months))
- Quality of life and mental health(Baseline, Day 3, Day 7)
- Quality of life and mental health(Completion of treatment (up to 12 months))
- Quality of life and mental health(Baseline to Month 24)