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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tuberculosis

• Study Type: Observational
• Enrollment (Estimated): 900

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

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

Description

Inclusion Criteria:

1. For patients with severe pulmonary tuberculosis, imaging and grading diagnosis meet any of the following:

   1. Damaged lung ≥ 1 lobe
   2. Chest CT shows lesions in ≥3 lung lobes
   3. Hematogenous disseminated pulmonary tuberculosis
   4. caseous pneumonia
   5. bronchial tuberculosis
   6. Multiple hilar or mediastinal lymph node enlargement in primary pulmonary tuberculosis
   7. Rifampicin-resistant, multidrug-resistant, polydrug-resistant or pan-drug-resistant tuberculosis
   8. Combined more than 2 cavities over 8mm
   9. Tuberculous massive hemoptysis
   10. Pulmonary tuberculosis complicated with acute infection (including multidrug-resistant bacterial infection, fungal infection or multiple infection)

   11. 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.
         • Heart failure caused by cardiac tamponade or constrictive pericarditis

       • Multiple sites of lymphatic tuberculosis or surgery is necessary

         • Cervical lymphatic tuberculosis
         • Mediastinal lymphatic tuberculosis
         • Abdominal or retroperitoneal lymph node tuberculosis

       • Abdominal tuberculosis, tuberculous peritonitis (ascites or multiple serous cavities)

         • Intestinal tuberculosis causes complete or incomplete intestinal root obstruction or perforation or massive bleeding or severe abdominal infection
         • Gastrointestinal hemorrhage caused by tuberculosis of the digestive system, etc.

       • Musculoskeletal tuberculosis

         • Spinal (cervical, thoracic, lumbar, sacral) tuberculosis
         • Bones in other parts
         • Merge surrounding abscess

       • Urinary or renal tuberculosis

         • Renal failure or damaged blood vessels caused by renal tuberculosis
         • Ureteral stenosis or blockage caused by urinary tuberculosis
       • Adrenal tuberculosis in hypoadrenal insufficiency
       • Liver tuberculosis
2. 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.
• 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.

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	2-year survival rate	2 years
2-year disability rate	2-year disability rate	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants with the presence of clinical symptoms		2 years
Incidence of complications in patients with different treatment regimens	Incidence of complications in patients with different treatment regimens	2 years
Length of hospital stay for patients	Length of hospital stay for patients	2 years
Proportion of patients admitted to the ICU	Proportion of patients admitted to the ICU	2 years

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2018
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: RETUBO-S