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Clinical Trials/NCT06011915
NCT06011915
Completed
Not Applicable

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

Tongji Hospital2 sites in 1 country638 target enrollmentAugust 22, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Central Nervous System Tuberculosis
Sponsor
Tongji Hospital
Enrollment
638
Locations
2
Primary Endpoint
2-year survival rate
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 22, 2017
End Date
July 26, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Qin Ning

Director and Chair of Department of Infectious Diseases

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

  • The patient meets the following criteria 1) or 2) or 3):
  • The discharge diagnosis is central nervous system tuberculosis, refer to the ICD-10 code related to central nervous system tuberculosis.
  • 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).
  • 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.

Outcomes

Primary Outcomes

2-year survival rate

Time Frame: 1 years,2 years

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

2-year disability rate

Time Frame: 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 Outcomes

  • length of hospital stay(2 years)
  • proportion of patients admitted to ICU(2 years)
  • Clinical features: age of onset, mode of onset(2 years)
  • The presense of clinical symptoms of patients(2 years)
  • Incidence of complications in patients with different treatment regimens(2 years)

Study Sites (2)

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