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Completed

NCT Number: NCT06011915

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 2-year survival rate

    Time frame: 1 years,2 years

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

  2. 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

  1. Clinical features: age of onset, mode of onset

    Time frame: 2 years

    age of onset, mode of onset

  2. The presense of clinical symptoms of patients

    Time frame: 2 years

    The number and severity of clinical symptoms of patients.

  3. Incidence of complications in patients with different treatment regimens

    Time frame: 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

    Time frame: 2 years

  5. proportion of patients admitted to ICU

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2023
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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