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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06021041
• Other study ID #: RETUBO-S
• Status: Active, not recruiting
• Start date: January 13, 2018
• Est. completion date: February 1, 2024

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 900
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• 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	2-year survival rate	2 years
Primary	2-year disability rate	2-year disability rate	2 years
Secondary	The number of participants with the presence of clinical symptoms		2 years
Secondary	Incidence of complications in patients with different treatment regimens	Incidence of complications in patients with different treatment regimens	2 years
Secondary	Length of hospital stay for patients	Length of hospital stay for patients	2 years
Secondary	Proportion of patients admitted to the ICU	Proportion of patients admitted to the ICU	2 years