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

Central Nervous System Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06011915
• Other study ID #: RETUBO-N
• Status: Completed
• Start date: August 22, 2017
• Est. completion date: July 26, 2023

Study information

• Verified date: August 2023
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 638
• Est. completion date: July 26, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Nervous System Tuberculosis
• Tuberculosis

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year survival rate	Calculate the 1-year survival rate and 2-year survival rate.	1 years,2 years
Primary	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	Clinical features: age of onset, mode of onset	age of onset, mode of onset	2 years
Secondary	The presense of clinical symptoms of patients	The number and severity of clinical symptoms of patients.	2 years
Secondary	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
Secondary	length of hospital stay		2 years
Secondary	proportion of patients admitted to ICU		2 years