Clinical trial NCT06011915: A Retrospective Study of Treatment Patterns and Clinical Outcomes in Patients With Central Nervous System Tuberculosis
Official title: A Retrospective Study of Treatment Patterns and Clinical Outcomes in Patients With Central Nervous System Tuberculosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Nervous System Tuberculosis
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 638
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 2-year survival rate
timeFrame: 1 years,2 years
measure: 2-year disability rate
timeFrame: 1 years,2 years
Secondary outcomes:
measure: Clinical features: age of onset, mode of onset
timeFrame: 2 years
measure: The presense of clinical symptoms of patients
timeFrame: 2 years
measure: Incidence of complications in patients with different treatment regimens
timeFrame: 2 years
measure: length of hospital stay
timeFrame: 2 years
measure: proportion of patients admitted to ICU
timeFrame: 2 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Hubei
country: China
facility: Wuhan Pulmonary Hospital(Wuhan Institute for Tuberculosis Control)
state: Wuhan
Study officials:
References: