Tuberculosis Clinical Registry in Europe

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tuberculosis
• Intervention / Treatment: Other: data collection

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Anca Vasiliu, MD PhD; Phone Number: +49 4537 188 8080; Email: tbnetregistry@fz-borstel.de

Study Locations

• Germany
  • Schleswig-Holstein
    • Borstel, Schleswig-Holstein, Germany, 23845
      • Research Center Borstel, Leibniz Lung Center
      • Contact: Anca Vasiliu, MD PhD; Phone Number: +49 4537 188 8080; Email: tbnetregistry@fz-borstel.de
• Italy
  • Verona
    • Negrar, Verona, Italy, 37024
      • IRCCS Ospedale Sacro Cuore Don Calabria
      • Contact: Lorenzo Guglielmetti, MD PhD; Phone Number: +39 0456013111; Email: tbnetregistry@fz-borstel.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Inpatients in tuberculosis care

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Extrapulmonary TB; Individuals affected by extrapulmonary tuberculosis	Other: data collection; Prospective data collection in a clinical data registry
drug-resistant TB; Individuals affected by rifampicin- and higher-resistant tuberculosis	Other: data collection; Prospective data collection in a clinical data registry
drug-susceptible TB; Individuals affected by rifampicin-susceptible tuberculosis	Other: data collection; Prospective data collection in a clinical data registry
TDM; Individuals under anti-tuberculosis treatment with an indication for therapeutic drug monitoring	Other: data collection; Prospective data collection in a clinical data registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extrapulmonary TB: Favourable treatment outcome	Identification of parameters that predict/are significantly associated with favorable outcome in EPTB	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	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	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.	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	December 2040

Collaborators and Investigators

• Sponsor: Research Center Borstel
• Collaborators: European Society of Clinical Microbiology and Infectious Diseases; Tuberculosis Network European Trialsgroup (TBnet e.V.)

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: PTLD; registry; extrapulmonary tuberculosis
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis, Extrapulmonary; Tuberculosis; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: TBnet_Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No