A Retrospective Study of Treatment Patterns and Clinical Outcomes in Patients With Central Nervous System Tuberculosis

Sponsor
Tongji Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06011915
Collaborator
(none)
638
2
71.1
319
4.5

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 in patients with central nervous system tuberculosis. All cases of central nervous system 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
    Actual Enrollment :
    638 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Retrospective Study of Treatment Patterns and Clinical Outcomes in Patients With Central Nervous System Tuberculosis
    Actual Study Start Date :
    Aug 22, 2017
    Actual Primary Completion Date :
    Jul 26, 2023
    Actual Study Completion Date :
    Jul 26, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 2-year survival rate [1 years,2 years]

      Calculate the 1-year survival rate and 2-year survival rate.

    2. 2-year disability rate [1 years,2 years]

      Calculate the 1-year disability rate and 2-year disability rate. Common disabilities include aphasia, hemiplegia, paraplegia, deafness, blindness, mental retardation, etc. For reference, please refer to the 《Grading of Human Injury and Disability Degree》 and 《Guidance for determination of cause-and-effect relationship between personal injury and disease》.

    Secondary Outcome Measures

    1. Clinical features: age of onset, mode of onset [2 years]

      age of onset, mode of onset

    2. The presense of clinical symptoms of patients [2 years]

      The number and severity of clinical symptoms of patients.

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

      The electronic medical record system was used to collect patients' complications from baseline (admission) to 24 months, and the incidence of complications of different treatment options was compared.

    4. length of hospital stay [2 years]

    5. proportion of patients admitted to ICU [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • The patient meets the following criteria 1) or 2) or 3):
    1. The discharge diagnosis is central nervous system tuberculosis, refer to the ICD-10 code related to central nervous system tuberculosis.

    2. The discharge diagnosis was tuberculous meningitis (ICD-10: A17.000), or tuberculous cerebrospinal meningitis (ICD-10: A17.001), or tuberculous meningoencephalitis (ICD-10: A17.803 ), or tuberculous encephalitis (ICD-10: A17.804), or tuberculous brain abscess (ICD-10: A17.805), or spinal tuberculosis (ICD-10: A17.806), or tuberculous encephalitis Water (ICD-10: A17.807).

    3. Tuberculous meningitis diagnosed according to the "Guidelines for Diagnosis and Treatment of Central Nervous System Tuberculosis in China (2019 Edition)"

    • 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.

    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, Director and Chair of Department of Infectious Diseases, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT06011915
    Other Study ID Numbers:
    • RETUBO-N
    First Posted:
    Aug 25, 2023
    Last Update Posted:
    Aug 28, 2023
    Last Verified:
    Aug 1, 2023
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 28, 2023