A Retrospective Study on the Treatment Pattern and Clinical Prognosis of Severe Tuberculosis Patients
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ClinicalTrials.gov Identifier: NCT06021041 |
Recruitment Status :
Active, not recruiting
First Posted : September 1, 2023
Last Update Posted : September 1, 2023
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Condition or disease |
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Tuberculosis |
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 |
- 2-year survival rate [ Time Frame: 2 years ]2-year survival rate
- 2-year disability rate [ Time Frame: 2 years ]2-year disability rate
- The number of participants with the presence of clinical symptoms [ Time Frame: 2 years ]
- Incidence of complications in patients with different treatment regimens [ Time Frame: 2 years ]Incidence of complications in patients with different treatment regimens
- Length of hospital stay for patients [ Time Frame: 2 years ]Length of hospital stay for patients
- Proportion of patients admitted to the ICU [ Time Frame: 2 years ]Proportion of patients admitted to the ICU
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
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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)
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Combined with extrapulmonary tuberculosis
- Intracranial tuberculosis, spinal cord and/or meningeal tuberculosis
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Pleural effusion, pericardial effusion
- Empyema or empyema, hemopneumothorax, tracheobronchopleural fistula and severe infection.
- Heart failure caused by cardiac tamponade or constrictive pericarditis
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Multiple sites of lymphatic tuberculosis or surgery is necessary
- Cervical lymphatic tuberculosis
- Mediastinal lymphatic tuberculosis
- Abdominal or retroperitoneal lymph node tuberculosis
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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.
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Musculoskeletal tuberculosis
- Spinal (cervical, thoracic, lumbar, sacral) tuberculosis
- Bones in other parts
- Merge surrounding abscess
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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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06021041
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 |
Responsible Party: | Qin Ning, Professor, Tongji Hospital |
ClinicalTrials.gov Identifier: | NCT06021041 |
Other Study ID Numbers: |
RETUBO-S |
First Posted: | September 1, 2023 Key Record Dates |
Last Update Posted: | September 1, 2023 |
Last Verified: | August 2023 |
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Bacterial Infections and Mycoses Infections |