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NCT Number: NCT07677904

Tuberculosis Clinical Registry in Europe

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Tuberculosis, Extrapulmonary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Center Borstel, Leibniz Lung Center, Borstel, Schleswig-Holstein, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Tuberculosis
  • Age ≥ 18 years
  • Capacity to provide informed consent
  • Written informed consent to participate in the study

Exclusion criteria

  • Lack of capacity to provide informed consent
  • Age < 18 years

Treatment and study plan

Data Collection

Other

Prospective data collection in a clinical data registry

Primary outcomes

  1. Extrapulmonary TB: Favourable treatment outcome

    Time frame: December 2040

    Identification of parameters that predict/are significantly associated with favorable outcome in EPTB

  2. 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

  3. 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

  4. 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.

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anca Vasiliu, MD PhD

CONTACT

[email protected]

+49 4537 188 8080

Sponsors and collaborators

Lead sponsor

Research Center Borstel

Other

Collaborators

  • European Society of Clinical Microbiology and Infectious Diseases
  • Tuberculosis Network European Trialsgroup (TBnet e.V.)

Registry information

Official study title

Tuberculosis Clinical Registry in Europe - the TBnet Registry

Important dates

Study start
2026
Primary completion
2040
Study completion
2040
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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