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

Completed

• Conditions: Central Nervous System Tuberculosis

• Registration Number: NCT06011915
• Lead Sponsor: Tongji Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-22
• Primary Completion: 2023-07-26
• Study Completion: 2023-07-26
• Status Verified: 2023-08
• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-25
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 638

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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》.
2-year survival rate	1 years,2 years	Calculate the 1-year survival rate and 2-year survival rate.

Secondary Outcome Measures

Name	Time	Method
Clinical features: age of onset, mode of onset	2 years	age of onset, mode of onset
The presense of clinical symptoms of patients	2 years	The number and severity of clinical symptoms of patients.
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.
length of hospital stay	2 years
proportion of patients admitted to ICU	2 years

Trial Locations

Locations (2)

Wuhan Pulmonary Hospital(Wuhan Institute for Tuberculosis Control); 🇨🇳 Hubei, Wuhan, China

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