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

• ClinicalTrials.gov Identifier: NCT06021041
• Recruitment Status: Active, not recruiting
• First Posted: September 1, 2023
• Last Update Posted: September 1, 2023
• Sponsor: Tongji Hospital
• Information provided by (Responsible Party): Qin Ning, Tongji Hospital

Study Description

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.

Condition or disease
Tuberculosis

Study Design

• Study Type: Observational
• Estimated Enrollment: 900 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective Study on the Treatment Pattern and Clinical Prognosis of Severe Tuberculosis Patients
• Actual Study Start Date: January 13, 2018
• Estimated Primary Completion Date: February 1, 2024
• Estimated Study Completion Date: February 1, 2024

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 2-year survival rate [ Time Frame: 2 years ]
   2-year survival rate
2. 2-year disability rate [ Time Frame: 2 years ]
   2-year disability rate

Secondary Outcome Measures :

1. The number of participants with the presence of clinical symptoms [ Time Frame: 2 years ]
2. Incidence of complications in patients with different treatment regimens [ Time Frame: 2 years ]
   Incidence of complications in patients with different treatment regimens
3. Length of hospital stay for patients [ Time Frame: 2 years ]
   Length of hospital stay for patients
4. Proportion of patients admitted to the ICU [ Time Frame: 2 years ]
   Proportion of patients admitted to the ICU

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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.

Criteria

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.

Contacts and Locations

Locations

China, Hubei

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

Wuhan, Hubei, China, 430030

China, Wuhan

Wuhan Pulmonary Hospital(Wuhan Institute for Tuberculosis Control)

Hubei, Wuhan, China, 430030

Sponsors and Collaborators

Tongji Hospital

More Information

• Responsible Party: Qin Ning, Professor, Tongji Hospital
• ClinicalTrials.gov Identifier: NCT06021041
• Other Study ID Numbers: RETUBO-S
• First Posted: September 1, 2023
• Last Update Posted: September 1, 2023
• Last Verified: August 2023

Additional relevant MeSH terms:

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