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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorBeijing Chest Hospital, Capital Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial population

The study population consists of patients diagnosed with intestinal tuberculosis, covering both the retrospective and prospective research stages. The Retrospective Intestinal Tuberculosis Cohort includes patients diagnosed with intestinal tuberculosis between January 2011 and December 2025, with complete medical records and follow-up data (including mortality status). The Prospective Intestinal Tuberculosis Cohort includes newly diagnosed intestinal tuberculosis patients who can cooperate with follow-up and provide complete clinical information. The study population is mainly used to analyze the risk factors related to mortality in intestinal tuberculosis patients, so as to provide a scientific basis for optimizing clinical management and improving the prognosis of patients.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational

    Other intervention

    Observational

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Retrospective Intestinal Tuberculosis Cohort1 intervention
Group B: Prospective Intestinal Tuberculosis Cohort1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality in patients with intestinal tuberculosis.

Death of the study subject due to any cause during the study period

Time frame
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

Secondary outcomes

Other outcomes

Sponsors and contacts

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