Tuberculosis Clinical Registry in Europe

NCT07677904 | Not Yet Recruiting

• 1 other identifier: TBnet_Registry
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Tuberculosis

Keywords

registry; extrapulmonary tuberculosis; PTLD

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

Extrapulmonary TB

Individuals affected by extrapulmonary tuberculosis

Other: data collection

drug-resistant TB

Individuals affected by rifampicin- and higher-resistant tuberculosis

Other: data collection

drug-susceptible TB

Individuals affected by rifampicin-susceptible tuberculosis

Other: data collection

TDM

Individuals under anti-tuberculosis treatment with an indication for therapeutic drug monitoring

Other: data collection

Interventions

data collection OTHER

Prospective data collection in a clinical data registry

Extrapulmonary TB; TDM; drug-resistant TB; drug-susceptible TB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients in tuberculosis care

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

Research Center Borstel, Leibniz Lung Center

Borstel, Schleswig-Holstein, 23845, Germany

Location

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Verona, 37024, Italy

Location

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Extrapulmonary

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Anca Vasiliu, MD PhD

CONTACT

+49 4537 188 8080; tbnetregistry@fz-borstel.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anca Vasiliu MD PhD

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); IT (1)