TuberculosisNCT06021041
A Retrospective Study on the Treatment Pattern and Clinical Prognosis of Severe Tuberculosis Patients
An observational study of Tuberculosis, run by Tongji Hospital at 2 sites in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis
- How many people
- 900 participants
- Where
- 2 sitesChina
- Study dates
- 13 Jan 2018to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized patients diagnosed with severe tuberculosis from the Grade A tertiary hospital in Hubei Province, China.
Who may be able to join
- 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
Show all 33Show fewer
- 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.
- 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
- Age and gender are not limited.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Wuhan Pulmonary Hospital(Wuhan Institute for Tuberculosis Control)
Hubei, Wuhan, 430030
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
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
- Medical subject headings
- Tuberculosis
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year survival rate
2-year survival rate
Measured: 2 years
2-year disability rate
2-year disability rate
Measured: 2 years
Secondary outcomes (4)
The number of participants with the presence of clinical symptoms
Measured: 2 years
Incidence of complications in patients with different treatment regimens
Incidence of complications in patients with different treatment regimens
Measured: 2 years
Length of hospital stay for patients
Length of hospital stay for patients
Measured: 2 years
Proportion of patients admitted to the ICU
Proportion of patients admitted to the ICU
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start13 Jan 2018
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021041
- Sponsor's protocol ID
- RETUBO-S
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on the Treatment Pattern and Clinical Prognosis of Severe Tuberculosis Patients
- ClinicalTrials.gov ID
- NCT06021041
- Acronym / sponsor ID
- RETUBO-S
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 13 Jan 2018 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients diagnosed with severe tuberculosis from the Grade A tertiary hospital in Hubei Province, China.
Key inclusion criteria (33 listed)
- For patients with severe pulmonary tuberculosis, imaging and grading diagnosis meet any of the following:
- Age and gender are not limited.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
2-year survival rate
Time frame: 2 years
2-year survival rate
2-year disability rate
Time frame: 2 years
2-year disability rate
4 secondary outcomes
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
Length of hospital stay for patients
Time frame: 2 years
Proportion of patients admitted to the ICU
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Tongji Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year survival rate (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.