Risk factors of negative outcomes for pleural tuberculosis
| ISRCTN | ISRCTN11977620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11977620 |
| Sponsor | Sechenov University |
| Funder | Investigator initiated and funded |
- Submission date
- 09/04/2026
- Registration date
- 10/04/2026
- Last edited
- 10/04/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Tuberculous empyema is a serious condition where infected fluid collects around the lungs. It can be difficult to treat and may require surgery. This study aims to better understand which factors affect recovery, complications, and relapse.
Who can participate?
Patients diagnosed with tuberculous empyema who were treated in specialized tuberculosis centers between 2003 and 2023 and have complete medical records.
What does the study involve?
This is a retrospective study. Researchers review existing medical records to collect information about patient characteristics, type of treatment (medical, minimally invasive surgery, or open surgery), and outcomes. No new treatments or procedures are given.
What are the possible benefits and risks of participating?
There are no direct benefits or risks, as no interventions are performed. The study may help improve future treatment strategies.
Where is the study run from?
Three tuberculosis centers in Russia.
When is the study starting and how long is it expected to run for?
The study analyzes data from 2003 to 2023 and is expected to be completed in 2026.
Who is funding the study?
Investigator initiated and funded.
Who is the main contact?
Prof Boris Giller, gillerbd@gmail.com, giller-thorax@mail.ru
Contact information
Scientific, Principal investigator, Public
Department of Phthisiopulmonology and Thoracic Surgery named after M.I. Perelman
First Moscow State Medical University
Moscow
119048
Russian Federation
| Phone | +79168681291 |
|---|---|
| giller-thorax@mail.ru |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Epidemiological study |
| Scientific title | The outcome determinants in tuberculous empyema |
| Study acronym | TBEMP1 |
| Study objectives | To evaluate the correlation between treatment strategy, disease stage, and microbiological characteristics to determine outcomes in patients with tuberculous empyema |
| Ethics approval(s) |
Approved 02/04/2026, Local Ethics Committee of Sechenov University (Trubetskaya 8, Moscow, 119048, Russian Federation; +7(495)6229706; iec@staff.sechenov.ru), ref: 08-26 |
| Health condition(s) or problem(s) studied | Patients with diagnosed tuberculosis empyema |
| Intervention | This study is designed as a multicenter retrospective observational cohort study evaluating clinical outcomes in patients with tuberculous empyema treated between 2003 and 2023 across three tuberculosis centers. Medical records of patients with suspected tuberculous empyema are reviewed for eligibility. Participants are included if a confirmed diagnosis of tuberculous empyema is established and sufficient data on treatment strategy and clinical outcomes are available. Exclusion criteria include alternative pleural disease etiology, incomplete follow-up data, performance of lung resection procedures in addition to empyema management, and presence of human immunodeficiency virus infection. Interventions are not assigned but reflect routine clinical practice and include conservative management (pleural drainage and antitubercular therapy), video-assisted thoracoscopic surgery, or open surgical procedures. Data collected include demographic, clinical, and microbiological variables. Outcomes assessed include relapse, residual radiological changes, and duration of pleural exudation. Multivariable statistical models are applied to evaluate independent predictors of outcomes. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 01/01/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 1500 |
| Total final enrolment | 1052 |
| Key inclusion criteria | 1. Diagnosed tuberculosis empyema 2. Sufficient documentation of clinical presentation, treatment strategy, and outcomes |
| Key exclusion criteria | 1. Patients with different pathology 2. Absent follow-up 3. Lung resections alongside surgical or conservative management of empyema 4. Patients with HIV |
| Date of first enrolment | 01/09/2023 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- Russian Federation
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
10/04/2026: Study’s existence confirmed by the Local Ethics Committee of Sechenov University, Russian Federation.
