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

NCT06011915 | Completed

• 1 other identifier: RETUBO-N
• Study Type: observational
• Target: 638
• Locations: 1 country
• Sites: 2

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.

Conditions

Central Nervous System Tuberculosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

• length of hospital stay

  2 years

• proportion of patients admitted to ICU

  2 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with no clear diagnosis at discharge.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (2)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Wuhan Pulmonary Hospital(Wuhan Institute for Tuberculosis Control)

Hubei, Wuhan, 430030, China

Location

MeSH Terms

Conditions

Tuberculosis, Central Nervous System

Condition Hierarchy (Ancestors)

Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Tuberculosis, Extrapulmonary; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Chair of Department of Infectious Diseases

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 25, 2023
• Study Start: August 22, 2017
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

CN (2)