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.

Study Overview

• Status: Completed
• Conditions: Central Nervous System Tuberculosis

• Study Type: Observational
• Enrollment (Actual): 638

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Wuhan
    • Hubei, Wuhan, China, 430030
      • Wuhan Pulmonary Hospital(Wuhan Institute for Tuberculosis Control)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Central nervous system tuberculosis patients came from Wuhan Pulmonary Hospital, which is a third-class A-level specialized hospital integrating tuberculosis prevention and control, clinical diagnosis and treatment of pulmonary diseases, science, teaching and research, located in Wuhan, Hubei Province, China.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year survival rate	Calculate the 1-year survival rate and 2-year survival rate.	1 years,2 years
2-year disability rate	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》.	1 years,2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical features: age of onset, mode of onset	age of onset, mode of onset	2 years
Incidence of complications in patients with different treatment regimens	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.	2 years
length of hospital stay		2 years
proportion of patients admitted to ICU		2 years
The presense of clinical symptoms of patients	The number and severity of clinical symptoms of patients.	2 years

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2017
• Primary Completion (Actual): July 26, 2023
• Study Completion (Actual): July 26, 2023

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Central Nervous System Bacterial Infections; Tuberculosis, Extrapulmonary; Tuberculosis; Tuberculosis, Central Nervous System
• Other Study ID Numbers: RETUBO-N