A Retrospective Study on the Treatment Pattern and Clinical Prognosis of Severe Tuberculosis Patients

NCT06021041 | Unknown

• 1 other identifier: RETUBO-S
• Study Type: observational
• Target: 900
• 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 of severe tuberculosis patients. All cases of severe 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

Tuberculosis

Outcome Measures

Primary Outcomes (2)

• 2-year survival rate

  2-year survival rate

  2 years

• 2-year disability rate

  2-year disability rate

  2 years

Secondary Outcomes (4)

• The number of participants with the presence of clinical symptoms

  2 years

• Incidence of complications in patients with different treatment regimens

  2 years

• Length of hospital stay for patients

  2 years

• Proportion of patients admitted to the 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

Hospitalized patients diagnosed with severe tuberculosis from the Grade A tertiary hospital in Hubei Province, China.

You may qualify if:

• For patients with severe pulmonary tuberculosis, imaging and grading diagnosis meet any of the following:
• Damaged lung ≥ 1 lobe
• Chest CT shows lesions in ≥3 lung lobes
• Hematogenous disseminated pulmonary tuberculosis
• caseous pneumonia
• bronchial tuberculosis
• Multiple hilar or mediastinal lymph node enlargement in primary pulmonary tuberculosis
• Rifampicin-resistant, multidrug-resistant, polydrug-resistant or pan-drug-resistant tuberculosis
• Combined more than 2 cavities over 8mm
• Tuberculous massive hemoptysis
• Pulmonary tuberculosis complicated with acute infection (including multidrug-resistant bacterial infection, fungal infection or multiple infection)
• Combined with extrapulmonary tuberculosis
• Intracranial tuberculosis, spinal cord and/or meningeal tuberculosis
• Pleural effusion, pericardial effusion
• Empyema or empyema, hemopneumothorax, tracheobronchopleural fistula and severe infection.

You may not qualify if:

• Patients with no clear diagnosis at discharge.
• The discharge diagnosis was central nervous system tuberculosis, or tuberculous meningitis, or tuberculous cerebrospinal meningitis, or tuberculous meningoencephalitis, or tuberculous encephalitis, or tuberculous brain abscess, or spinal tuberculosis, or tuberculous Hydrocephalus, and is currently participating in other clinical studies.

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

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 1, 2023
• Study Start: January 13, 2018
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

CN (2)