ClinicalTrials.gg
Not yet recruitingNCT07677904Updated Jul 1, 2026

Tuberculosis Clinical Registry in Europe

An observational study in Tuberculosis, sponsored by Research Center Borstel. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Research Center Borstel · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Tuberculosis with a site in Germany — 3 open to participants now, 3 under way, none of them phase 3. Tuberculosis · Germany.

Started
2026
with 1 other
Observational
9 of 13
3 open now
Registered
13th of 13
by date
Lead sponsor
7 of 13
Research Center Borstel

Among the 13 studies in Tuberculosis with a site in Germany, this one is one of 2 that started in 2026, is one of 9 observational ones, and was the 13th registered.

Tuberculosis

1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.

Browse Tuberculosis studies →

Open to participants now

3 of the 13 studies in Tuberculosis with a site in Germany are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 109 Tuberculosis studies recruiting now, 64 (59%) set no upper age limit and 35 (32%) stop at 75 or younger; 48 take children under 18; 30 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

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).

03

Conditions studied

  • Tuberculosis

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Keywords

  • registry
  • extrapulmonary tuberculosis
  • PTLD
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Inpatients in tuberculosis care

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Lack of capacity to provide
  • Age \< 18 years
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Otherdata collection

    Prospective data collection in a clinical data registry

06

What researchers measure

Primary outcomes

  1. Extrapulmonary TB: Favourable treatment outcome

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

    Time frame: December 2040

  2. Drug-resistant TB: Description of treatment outcome

    Percentage of patients cured, failed, died, under/after therapy according to WHO and TBnet outcome criteria

    Time frame: December 2040

  3. 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

    Time frame: December 2040

  4. 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.

    Time frame: December 2040

  5. Therapeutic drug monitoring: Description of Pharmacokinetics

    Summary of pharmacokinetic parameters: Mean max/min concentrations, number of patients that are over-/under-/correctly dosed

    Time frame: December 2040

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Dec 2040, 173 months later.

Of 122 non-industry observational studies under Tuberculosis, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's planned 173 months is above that.

Counting every sponsor, half of 134 studies reached it within 36 months; a quarter within 21 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2026
First posted
Jul 1, 2026
StartEst.
Jul 2026
Primary completionEst.
Dec 2040
CompletionEst.
Dec 2040
Last update
Jul 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07677904
Lead sponsor
Research Center Borstel
Collaborators
European Society of Clinical Microbiology and Infectious Diseases, Tuberculosis Network European Trialsgroup (TBnet e.V.)
Responsible party
Anca Vasiliu (Anca Vasiliu MD PhD, Research Center Borstel) — Principal investigator
First posted
Jul 1, 2026
Start date
Jul 2026 (estimated)
Primary completion
Dec 2040 (estimated)
Completion
Dec 2040 (estimated)
Last update
Jul 1, 2026

Study contacts

Anca Vasiliu, MD PhD
Contact
tbnetregistry@fz-borstel.de
+49 4537 188 8080

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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