Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France (FrenchTB)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Tuberculosis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France - ANRS 464s FrenchTB
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Proportion of participants with successful anti-tuberculosis treatment outcome, defined as definite or probable cure, by Month 12 [Срок оценки: through treatment completion; Month 12]
- Success of the anti-tuberculosis treatment [Срок оценки: through treatment completion; Month 12]
Вторичные конечные точки (12)
- Early microbiological response [Срок оценки: Month 2]
- Positive culture [Срок оценки: Month 5]
- Tuberculosis-related death [Срок оценки: Month 5]
- Premature treatment interruption without resumption [Срок оценки: Month 5]
- Ongoing treatment at Month 12 due to interruption, resistance, adverse events, or initial failure [Срок оценки: Month 12]
- Transfer or loss to follow-up [Срок оценки: Month 5]
- All-cause mortality [Срок оценки: Until Month 24]
- Tuberculosis relapse [Срок оценки: Between end of treatment and Month 24]
- Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology [Срок оценки: treatment completion until Month 24]
- Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology and/or hypoxaemia [Срок оценки: treatment completion until Month 24]
- Clinical and radiological post-tuberculosis respiratory sequelae and not related to another Pulmonary pathology [Срок оценки: Baseline, completion or failure treatment (up to 12 months)]
- Functional impact and repercussions of respiratory sequelae [Срок оценки: Baseline, Month 12, completion or failure treatment]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 2 центра
- AP-HP Hôpital Saint Louis - Service des Maladies Infectieuses et Tropicales — Paris
- Service de pneumologie et maladies infectieuses, Centre hospitalier Delafontaine — Saint-Denis
Идентификаторы
NCT: NCT06893757 · ANRS 0464s FrenchTB · 2024-A01834-43