TuberculosisNCT07677904
Tuberculosis Clinical Registry in Europe
An observational study of Tuberculosis, run by Research Center Borstel at 2 sites in 2 countries.
Trial summary
The TBnet registry is a multinational, prospective tuberculosis registry established by the Tuberculosis Network European Trialsgroup (TBnet e.V.) to collect and analyze long-term data from TB patients across Europe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- data collection
- How many people
- 1,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2026to Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients in tuberculosis care
Who may be able to join
- Diagnosis of Tuberculosis
- Age ≥ 18 years
- Capacity to provide informed consent
- Written informed consent to participate in the study
Who cannot join
- Lack of capacity to provide informed consent
- Age < 18 years
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site
Research Center Borstel, Leibniz Lung Center
Borstel, Schleswig-Holstein, 23845
Anca Vasiliu, MD PhD, +49 4537 188 8080, tbnetregistry@fz-borstel.de
Italy1 site
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Verona, 37024
Lorenzo Guglielmetti, MD PhD, +39 0456013111, tbnetregistry@fz-borstel.de
About this study
Official title: Tuberculosis Clinical Registry in Europe - the TBnet Registry
The TBnet registry is a multinational, prospective tuberculosis registry established by the Tuberculosis Network European Trialsgroup (TBnet e.V.) to collect and analyze long-term data from TB patients across Europe. Its purpose is to centralize data on TB epidemiology, prevention, diagnosis, and treatment to improve care, support research, and ultimately help eliminate TB. The registry captures risk factors, diagnostic details (e.g., microbiology, imaging, drug resistance), treatment data, side effects, outcomes, and late complications.
Read the detailed description
In Western Europe, however, tuberculosis is a rare disease, and individual clinics see only small numbers of patients. For clinical research on the epidemiology, prevention, diagnosis, and treatment of tuberculosis, it is therefore essential that patient data are collected and analyzed in a centralized manner. This allows for the adequate inclusion of at-risk groups and studying less common forms of tuberculosis (e.g., multidrug-resistant tuberculosis, extrapulmonary tuberculosis). Hence, the Tuberculosis Network European Trialsgroup TBnet e.V., aims to establish a tuberculosis registry in which long-term datasets from TB patients across Europe will be stored. The findings obtained from the tuberculosis registry will make an important contribution to combating and ultimately eliminating TB. TBnet is a pan-European clinical research network dedicated to improving the diagnosis, treatment, and prevention of tuberculosis and related mycobacterial diseases. Founded in 2006, TBnet brings together clinicians, scientists, and public health experts from more than 30 countries. The network has established large collaborative cohorts and conducts multicenter clinical studies, registries, and consensus projects that have shaped international TB guidelines. The TBnet Steering Committee will serve as data access committee: Research questions/data inquiries will be submitted to the TBnet Steering Committee through a structured process on the TBnet website and are approved only after internal and external peer review (as outlined in the TBnet statutes).
- Conditions
- Tuberculosis
- Being tested
- data collection
- Keywords
- registry, extrapulmonary tuberculosis, PTLD
- Medical subject headings
- Tuberculosis, Tuberculosis, Extrapulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
Prospective data collection in a clinical data registry
| Study group | Role | What they receive |
|---|---|---|
| Extrapulmonary TB | Individuals affected by extrapulmonary tuberculosis Receives: Other: data collection | |
| drug-resistant TB | Individuals affected by rifampicin- and higher-resistant tuberculosis Receives: Other: data collection | |
| drug-susceptible TB | Individuals affected by rifampicin-susceptible tuberculosis Receives: Other: data collection | |
| TDM | Individuals under anti-tuberculosis treatment with an indication for therapeutic drug monitoring Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extrapulmonary TB: Favourable treatment outcome
Identification of parameters that predict/are significantly associated with favorable outcome in EPTB
Measured: December 2040
Drug-resistant TB: Description of treatment outcome
Percentage of patients cured, failed, died, under/after therapy according to WHO and TBnet outcome criteria
Measured: December 2040
Drug-resistant TB: Description of treatment completion
Percentage of patients who develop serious/severe drug-related adverse events/who have to change regimen due to drug-related adverse events
Measured: December 2040
Drug-susceptible TB: Mortality risk score
Development of a TB mortality risk score, defined by a final set of predictors and a weighted scoring system based on routine clinical, radiological, microbiological, and laboratory data.
Measured: December 2040
Therapeutic drug monitoring: Description of Pharmacokinetics
Summary of pharmacokinetic parameters: Mean max/min concentrations, number of patients that are over-/under-/correctly dosed
Measured: December 2040
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (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.
- 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Center Borstel
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Clinical Microbiology and Infectious Diseases, Tuberculosis Network European Trialsgroup
- Responsible party
- Principal investigator, Anca Vasiliu, Research Center Borstel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677904
- Sponsor's protocol ID
- TBnet_Registry
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tuberculosis Clinical Registry in Europe - the TBnet Registry
- ClinicalTrials.gov ID
- NCT07677904
- Acronym / sponsor ID
- TBnet_Registry
- Conditions
- Tuberculosis
- Keywords
- registry, extrapulmonary tuberculosis, PTLD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Research Center BorstelUniversity, hospital or other
- Collaborators
- European Society of Clinical Microbiology and Infectious Diseases, Tuberculosis Network European Trialsgroup
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 1 Jul 2026 (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.
The TBnet registry is a multinational, prospective tuberculosis registry established by the Tuberculosis Network European Trialsgroup (TBnet e.V.) to collect and analyze long-term data from TB patients across Europe. Its purpose is to centralize data on TB epidemiology, prevention, diagnosis, and treatment to improve care, support research, and ultimately help eliminate TB. The registry captures risk factors, diagnostic details (e.g., microbiology, imaging, drug resistance), treatment data, side effects, outcomes, and late complications.
Detailed description
In Western Europe, however, tuberculosis is a rare disease, and individual clinics see only small numbers of patients. For clinical research on the epidemiology, prevention, diagnosis, and treatment of tuberculosis, it is therefore essential that patient data are collected and analyzed in a centralized manner. This allows for the adequate inclusion of at-risk groups and studying less common forms of tuberculosis (e.g., multidrug-resistant tuberculosis, extrapulmonary tuberculosis). Hence, the Tuberculosis Network European Trialsgroup TBnet e.V., aims to establish a tuberculosis registry in which long-term datasets from TB patients across Europe will be stored. The findings obtained from the tuberculosis registry will make an important contribution to combating and ultimately eliminating TB. TBnet is a pan-European clinical research network dedicated to improving the diagnosis, treatment, and prevention of tuberculosis and related mycobacterial diseases. Founded in 2006, TBnet brings together clinicians, scientists, and public health experts from more than 30 countries. The network has established large collaborative cohorts and conducts multicenter clinical studies, registries, and consensus projects that have shaped international TB guidelines. The TBnet Steering Committee will serve as data access committee: Research questions/data inquiries will be submitted to the TBnet Steering Committee through a structured process on the TBnet website and are approved only after internal and external peer review (as outlined in the TBnet statutes).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Extrapulmonary TB | – | Other: data collectionIndividuals affected by extrapulmonary tuberculosis |
| drug-resistant TB | – | Other: data collectionIndividuals affected by rifampicin- and higher-resistant tuberculosis |
| drug-susceptible TB | – | Other: data collectionIndividuals affected by rifampicin-susceptible tuberculosis |
| TDM | – | Other: data collectionIndividuals under anti-tuberculosis treatment with an indication for therapeutic drug monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients in tuberculosis care
Key inclusion criteria (4 listed)
- Diagnosis of Tuberculosis
- Age ≥ 18 years
- Capacity to provide informed consent
- Written informed consent to participate in the study
Key exclusion criteria (2 listed)
- Lack of capacity to provide informed consent
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectionProspective data collection in a clinical data registry | Other | Extrapulmonary TB, TDM, drug-resistant TB, drug-susceptible TB |
Primary outcome
Extrapulmonary TB: Favourable treatment outcome
Time frame: December 2040
Identification of parameters that predict/are significantly associated with favorable outcome in EPTB
Drug-resistant TB: Description of treatment outcome
Time frame: December 2040
Percentage of patients cured, failed, died, under/after therapy according to WHO and TBnet outcome criteria
Drug-resistant TB: Description of treatment completion
Time frame: December 2040
Percentage of patients who develop serious/severe drug-related adverse events/who have to change regimen due to drug-related adverse events
Drug-susceptible TB: Mortality risk score
Time frame: December 2040
Development of a TB mortality risk score, defined by a final set of predictors and a weighted scoring system based on routine clinical, radiological, microbiological, and laboratory data.
Therapeutic drug monitoring: Description of Pharmacokinetics
Time frame: December 2040
Summary of pharmacokinetic parameters: Mean max/min concentrations, number of patients that are over-/under-/correctly dosed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Research Center Borstel at 2 sites in 2 countries.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 1 Jul 2026. 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 Germany, Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anca Vasiliu, MD PhD (+49 4537 188 8080, tbnetregistry@fz-borstel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extrapulmonary TB: Favourable treatment outcome (time frame: December 2040). The study lists 5 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 Jul 2026.