A 15-year Cohort Study on Risk Factors of Mortality in Patients With Intestinal Tuberculosis

Официальное название

A 15-Year Cohort Study to Analyze Risk Factors for Mortality in Patients With Intestinal Tuberculosis

Обзор

This study adopts a combined design of retrospective cohort study followed by prospective observational study, which is conducted at Beijing Chest Hospital. The study first collects and analyzes the data of intestinal tuberculosis patients diagnosed and followed up in the hospital from 2011-1 to 2025-12 (a 15-year retrospective period) as the retrospective cohort, aiming to initially identify the risk factors associated with mortality in patients with intestinal tuberculosis. On the basis of the retrospective analysis results, the study will further carry out a prospective observational study, continuously enroll new intestinal tuberculosis patients, follow up their clinical status, treatment response and mortality outcomes for a certain period, and verify and supplement the risk factors identified in the retrospective stage. Clinical data, including demographic characteristics, clinical manifestations, laboratory test results, treatment regimens, and follow-up outcomes (mortality status), will be collected and sorted out in both stages. Univariate and multivariate statistical analyses will be used to screen and verify potential risk factors (such as age, disease severity, comorbidities, and treatment compliance) that affect the mortality of patients with intestinal tuberculosis. The results of this study are expected to provide scientific evidence for optimizing the clinical management, risk assessment, and prognostic improvement of patients with intestinal tuberculosis, and further guide the formulation of targeted prevention and treatment strategies.

Вмешательства

• Другое Observational
  Observational

Первичные конечные точки

• All-cause mortality in patients with intestinal tuberculosis. [Срок оценки: For the Retrospective Intestinal Tuberculosis Cohort, the time frame is 15 years, from January 2011 to December 2025; for the Prospective Intestinal Tuberculosis Cohort, the time frame is 3 years from the date of the first patient enrollment]

Критерии участия

Критерии включения

• Aged ≥18 years old (no upper age limit) at the time of intestinal tuberculosis diagnosis;
• Diagnosed with intestinal tuberculosis in accordance with clinical diagnostic criteria (combined with clinical manifestations, laboratory examinations, imaging findings, and/or pathological results);
• For the Retrospective Intestinal Tuberculosis Cohort: diagnosed between January 2011 and December 2025, with complete medical records and follow-up data (including mortality status);
• For the Prospective Intestinal Tuberculosis Cohort: newly diagnosed, able to cooperate with regular follow-up, and sign the informed consent form (if applicable);
• No severe cognitive impairment or mental illness that affects the collection of clinical data and follow-up.

Критерии исключения

• Patients with incomplete diagnosis of intestinal tuberculosis (no clear clinical, laboratory, imaging or pathological evidence to confirm the diagnosis);
• Patients with concurrent severe extrapulmonary tuberculosis (such as tuberculous meningitis, miliary tuberculosis) that may independently affect mortality outcomes;
• For the Retrospective Intestinal Tuberculosis Cohort: patients with incomplete medical records or missing key follow-up data (especially mortality status and related risk factor information);
• For the Prospective Intestinal Tuberculosis Cohort: patients who refuse to sign the informed consent form (if applicable), cannot cooperate with regular follow-up, or are lost to follow-up during the study period;
• Patients with severe comorbidities that may lead to rapid death (such as advanced malignant tumors, severe heart failure, end-stage liver/kidney disease) within the study period, which may interfere with the analysis of mortality risk factors related to intestinal tuberculosis;
• Patients with cognitive impairment, mental illness or other conditions that cannot provide effective clinical information or cooperate with the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Beijing Chest Hospital — Пекин

Идентификаторы

NCT: NCT07575061 · LW-2026-013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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