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A Retrospective Study on the Treatment Pattern and Clinical Prognosis of Severe Tuberculosis Patients

Sponsor
Tongji Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06021041
Collaborator
(none)
900
Enrollment
2
Locations
72.6
Anticipated Duration (Months)
450
Patients Per Site
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a retrospective clinical study to analyze the clinical characteristics, complications, and effects of different treatment options on long-term prognosis of severe tuberculosis patients. All cases of severe tuberculosis diagnosed between 2016 and 2021 were included in the electronic medical record system of one center, and data such as demographics, hospitalization information, clinical information, laboratory or imaging examinations, treatment plans, and outcomes were collected.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    900 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Retrospective Study on the Treatment Pattern and Clinical Prognosis of Severe Tuberculosis Patients
    Actual Study Start Date :
    Jan 13, 2018
    Anticipated Primary Completion Date :
    Feb 1, 2024
    Anticipated Study Completion Date :
    Feb 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 2-year survival rate [2 years]

      2-year survival rate

    2. 2-year disability rate [2 years]

      2-year disability rate

    Secondary Outcome Measures

    1. The number of participants with the presence of clinical symptoms [2 years]

    2. Incidence of complications in patients with different treatment regimens [2 years]

      Incidence of complications in patients with different treatment regimens

    3. Length of hospital stay for patients [2 years]

      Length of hospital stay for patients

    4. Proportion of patients admitted to the ICU [2 years]

      Proportion of patients admitted to the ICU

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. For patients with severe pulmonary tuberculosis, imaging and grading diagnosis meet any of the following:

    2. Damaged lung ≥ 1 lobe

    3. Chest CT shows lesions in ≥3 lung lobes

    4. Hematogenous disseminated pulmonary tuberculosis

    5. caseous pneumonia

    6. bronchial tuberculosis

    7. Multiple hilar or mediastinal lymph node enlargement in primary pulmonary tuberculosis

    8. Rifampicin-resistant, multidrug-resistant, polydrug-resistant or pan-drug-resistant tuberculosis

    9. Combined more than 2 cavities over 8mm

    10. Tuberculous massive hemoptysis

    11. Pulmonary tuberculosis complicated with acute infection (including multidrug-resistant bacterial infection, fungal infection or multiple infection)

    12. Combined with extrapulmonary tuberculosis

    • Intracranial tuberculosis, spinal cord and/or meningeal tuberculosis

    • Pleural effusion, pericardial effusion

    • Empyema or empyema, hemopneumothorax, tracheobronchopleural fistula and severe infection.

    • Heart failure caused by cardiac tamponade or constrictive pericarditis

    • Multiple sites of lymphatic tuberculosis or surgery is necessary

    • Cervical lymphatic tuberculosis

    • Mediastinal lymphatic tuberculosis

    • Abdominal or retroperitoneal lymph node tuberculosis

    • Abdominal tuberculosis, tuberculous peritonitis (ascites or multiple serous cavities)

    • Intestinal tuberculosis causes complete or incomplete intestinal root obstruction or perforation or massive bleeding or severe abdominal infection

    • Gastrointestinal hemorrhage caused by tuberculosis of the digestive system, etc.

    • Musculoskeletal tuberculosis

    • Spinal (cervical, thoracic, lumbar, sacral) tuberculosis

    • Bones in other parts

    • Merge surrounding abscess

    • Urinary or renal tuberculosis

    • Renal failure or damaged blood vessels caused by renal tuberculosis

    • Ureteral stenosis or blockage caused by urinary tuberculosis

    • Adrenal tuberculosis in hypoadrenal insufficiency

    • Liver tuberculosis

    1. Age and gender are not limited.
    Exclusion Criteria:

    • Patients with no clear diagnosis at discharge.

    • Patients judged by the investigator to be unsuitable for inclusion in this protocol.

    • The discharge diagnosis was central nervous system tuberculosis, or tuberculous meningitis, or tuberculous cerebrospinal meningitis, or tuberculous meningoencephalitis, or tuberculous encephalitis, or tuberculous brain abscess, or spinal tuberculosis, or tuberculous Hydrocephalus, and is currently participating in other clinical studies.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei China 430030
    2 Wuhan Pulmonary Hospital(Wuhan Institute for Tuberculosis Control) Hubei Wuhan China 430030

    Sponsors and Collaborators

    • Tongji Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qin Ning, Professor, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT06021041
    Other Study ID Numbers:
    • RETUBO-S
    First Posted:
    Sep 1, 2023
    Last Update Posted:
    Sep 1, 2023
    Last Verified:
    Aug 1, 2023
    Additional relevant MeSH terms:
    Tuberculosis

    Study Results

    No Results Posted as of Sep 1, 2023