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Идёт набор NCT07638670

Effect of Mycobacterial Infection on Immune Status

— Наблюдательное Tuberculosis

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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study, titled "Effect of Mycobacterial Infection on Immune Status" (EMIIS), investigates the immune-driven mechanisms of mycobacterial infections, focusing on the dynamic immune characteristics of multidrug-resistant tuberculosis (MDR-TB), nontuberculous mycobacterial (NTM) infections, and tuberculous pleurisy. Mycobacterial infections (including the Mycobacterium tuberculosis complex and nontuberculous mycobacteria) remain a major global public health threat. EMIIS is a single-center, randomized, single-blind,prospective study. The study recruited 120 participants, divided into groups of healthy individuals/community-acquired pneumonia patients, active pulmonary tuberculosis patients, latent tuberculosis infection patients, tuberculous pleurisy patients, and nontuberculous mycobacteria patients. Blood samples were collected from all groups within 3 days before treatment and 2-3 months after treatment. Pleural effusion samples were additionally collected from the tuberculous pleurisy group within 3 days before treatment and 2 months after treatment. Exhaled breath condensate (EBC) was collected from the nontuberculous mycobacteria group. Utilizing mass cytometry (CyTOF) and multi-dimensional indicators, the study aims to elucidate the immune-driven mechanisms of mycobacterial infections and provide new strategies for individualized treatment.

Первичные конечные точки

  • To establish a multi-immune pathway interaction network and composite biomarkers in mycobacterial infection thing [Срок оценки: 3 days before treatment and 2 months after treatment]
Вторичные конечные точки (8)
  • Immune cell subsets and mechanisms of possible effects of anti-tuberculosis drugs [Срок оценки: 3 days before treatment and 2 months after treatment]
  • Differences in immune subsets between normal persons and patients with active pulmonary tuberculosis [Срок оценки: 3 days before treatment and 2 months after treatment]
  • To explore whether the peripheral blood before treatment contains a certain marker can predict the short-term efficacy [Срок оценки: 3 days before treatment and 2 months after treatment]
  • Comparison of the dynamic changes of immune subsets in peripheral blood and pleural effusion of TP patients before and after treatment [Срок оценки: 3 days before treatment and 2 months after treatment]
  • To explore the differences of peripheral blood immune subsets between TP patients and healthy people before treatment [Срок оценки: 3 days before treatment and 2 months after treatment]
  • To explore the metabolic differences of three major nutrients between TP patients and healthy people before treatment [Срок оценки: 3 days before treatment and 2 months after treatment]
  • Differences in metabolic function between multidrug-resistant tuberculosis group and drug-sensitive tuberculosis group [Срок оценки: 3 days before treatment and 2 months after treatment]
  • Influence of immune status on the efficacy of NTM [Срок оценки: 3 days before treatment and 2 months after treatment]

Критерии участия

Inclusion Criteria and Exclusion Criteria:

Inclusion Criteria：

  • Age ≥ 18 years, all genders and races accepted.
  • Patients with active pulmonary tuberculosis diagnosed clinically or by bronchoscopy within less than 1 week.
  • Patients with latent tuberculosis infection (positive T-SPOT test but no evidence of active tuberculosis infection).
  • Patients with tuberculous pleurisy with onset within less than 1 week.
  • Voluntarily join this study and sign the informed consent form.
  • Patients whose drug susceptibility test or NGS results indicate resistance to at least isoniazid and rifampicin (MDR-TB).
  • Patients whose drug susceptibility test or NGS results indicate sensitivity to first-line anti-tuberculosis drugs.
  • Patients whose drug susceptibility test or NGS results indicate resistance to only one anti-tuberculosis drug.
  • Patients with newly identified nontuberculous mycobacterial infection (within less than 1 week) by sputum culture or NGS.

Exclusion Criteria：

  • Immunosuppressive conditions including HIV infection, long-term use (>1 month) of immunosuppressive agents or corticosteroids, severe malnutrition, etc.
  • Concurrent other lung diseases, severe liver or kidney dysfunction, severe endocrine diseases, hematological diseases, or malignant tumors that may affect the study outcomes.
  • Patients with diabetes mellitus.
  • Pregnant or lactating women.
  • Patients unable or unwilling to provide informed consent, or with poor compliance.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • The First Affiliated Hospital of Ningbo University — Ningbo

Идентификаторы

NCT: NCT07638670 · 2025-157A-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗