TuberculosisTB_DiagnosticsNCT07125274
Sputum-free Diagnostis of TB
An observational study of Tuberculosis, run by Research Center Borstel at 1 site in Germany.
Trial summary
The aim of this study is to identify new biomarkers that enable reliable, non-invasive diagnosis of tuberculosis (TB), including in patients who are unable to produce sputum. The study analyzes biomaterials (blood, urine, stool, sputum) collected from patients with suspected TB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Biomarker-guided diagnostic tests
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jun 2025to Dec 2026
- 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: Patients > 18 years of age, including women of childbearing potential with or without contraception. Only adult patients capable of giving informed consent will be included; obtaining consent from legal guardians is not planned.
Who may be able to join
- Suspected pulmonary or extrapulmonary tuberculosis, or confirmed pulmonary or extrapulmonary tuberculosis with less than 7 days of anti-tuberculosis treatment, OR other pulmonary infection (control group).
- Age ≥ 18 years
- Ability to provide informed consent
- Willingness to participate in the study
Who cannot join
- Lack of ability to provide informed consent
- Age < 18 years
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Hamburg, 20246
Thomas Theo Brehm, Dr. med., +49 152 2282 3999, t.brehm@uke.de
About this study
Official title: Biomarker-guided Diagnosis of Tuberculosis
The aim of this study is to identify new biomarkers that enable reliable, non-invasive diagnosis of tuberculosis (TB), including in patients who are unable to produce sputum. The study analyzes biomaterials (blood, urine, stool, sputum) collected from patients with suspected TB. Various diagnostic methods are applied to assess the feasibility of individual and combined biomarker tests.
Participating patients will provide biomaterial samples (blood, urine, stool, sputum) once. No additional examinations or invasive procedures will be performed. Routine diagnostic procedures remain unaffected.
This is a single-center, prospective observational study. Patients are enrolled as part of their clinical care at the University Medical Center Hamburg-Eppendorf.
- Conditions
- Tuberculosis
- Being tested
- Biomarker-guided diagnostic tests
- Keywords
- TB, diagnostics, sputum, sputum-free, transcriptomic, pathfast, CRISPR, stool, PCR
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker-guided diagnostic testsDiagnostic test
mRNA-Signature from blood; immunophenotyping from blood; MBLA from sputum, PATHFAST-LAM and EclLAM from sputum, stool, urine; CRISPR-Cas from blood; stool PCR; QuantiFERON(R)-TB Gold Plus.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected TB | Not described Receives: Diagnostic Test: Biomarker-guided diagnostic tests | |
| Other pulmonary infections (control group) | Not described Receives: Diagnostic Test: Biomarker-guided diagnostic tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of biomarker-guided diagnosis of TB - mRNA signatures
Assessment of the feasibility of tuberculosis (TB) diagnostics based on mRNA signatures.
Measured: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - cellular immunology
Assessment of the feasibility of tuberculosis (TB) diagnostics based on cellular immunology.
Measured: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - PATHFAST-LAM
Assessment of the feasibility of tuberculosis (TB) diagnostics based on PATHFAST-LAM.
Measured: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - EclLAM
Assessment of the feasibility of tuberculosis (TB) diagnostics based on EclLAM assays.
Measured: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - cell-free Mycobacterium tuberculosis DNA
Assessment of the feasibility of tuberculosis (TB) diagnostics based on cell-free Mycobacterium tuberculosis DNA.
Measured: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - MBLA
Assessment of the feasibility of tuberculosis (TB) diagnostics based on Mycobacterial Load Assay (MBLA).
Measured: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - stool PCR
Assessment of the feasibility of tuberculosis (TB) diagnostics based on stool PCR testing.
Measured: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - composit
Assessment of the feasibility of tuberculosis (TB) diagnostics based on a combination of mRNA signatures, cellular immunology, PATHFAST-LAM and EclLAM assays, cell-free Mycobacterium tuberculosis DNA analysis, MBLA, stool PCR testing, and QuantiFERON®-TB Gold Plus testing.
Measured: From enrollment to the end of the first week of treatment
Secondary outcomes (4)
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations
Degree of correlation between the different biomarkers.
Measured: From enrollment to the end of the first week of treatment.
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations
Qualitative and quantitative characterization of differences in biomarker profiles between pulmonary and extrapulmonary tuberculosis.
Measured: From enrollment to the end of the first week of treatment.
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations
Qualitative and quantitative characterization of sex-specific differences in biomarker expression patterns.
Measured: From enrollment to the end of the first week of treatment.
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations
Degree of correlation between biomarkers and disease severity, as well as their potential prognostic value.
Measured: From enrollment to the end of the first week of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start6 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Center Borstel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Theo Brehm, Research Center Borstel
- Investigators
- Christoph Lange, Prof. Dr. Dr. h.c., Study chair, Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung CenterMarylyn Martina Addo, Prof. Dr., Study chair, Institute for Infection Research and Vaccine Development, University Medical Center Hamburg-EppendorfStefan Schmiedel, Dr. med., Study chair, Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125274
- Sponsor's protocol ID
- TBDiagnostics2025-101457-BO-ff
- Acronym
- TB_Diagnostics
- Status last verified
- Aug 2025
- First submitted
- 29 Apr 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker-guided Diagnosis of Tuberculosis
- ClinicalTrials.gov ID
- NCT07125274
- Acronym / sponsor ID
- TB_Diagnostics / TBDiagnostics2025-101457-BO-ff
- Conditions
- Tuberculosis
- Keywords
- TB, diagnostics, sputum, sputum-free, transcriptomic, pathfast, CRISPR, stool
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Research Center BorstelUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Aug 2025 (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 aim of this study is to identify new biomarkers that enable reliable, non-invasive diagnosis of tuberculosis (TB), including in patients who are unable to produce sputum. The study analyzes biomaterials (blood, urine, stool, sputum) collected from patients with suspected TB. Various diagnostic methods are applied to assess the feasibility of individual and combined biomarker tests.
Participating patients will provide biomaterial samples (blood, urine, stool, sputum) once. No additional examinations or invasive procedures will be performed. Routine diagnostic procedures remain unaffected.
This is a single-center, prospective observational study. Patients are enrolled as part of their clinical care at the University Medical Center Hamburg-Eppendorf.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected TB | – | Diagnostic Test: Biomarker-guided diagnostic tests |
| Other pulmonary infections (control group) | – | Diagnostic Test: Biomarker-guided diagnostic tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients > 18 years of age, including women of childbearing potential with or without contraception. Only adult patients capable of giving informed consent will be included; obtaining consent from legal guardians is not planned.
Key inclusion criteria (4 listed)
- Suspected pulmonary or extrapulmonary tuberculosis, or confirmed pulmonary or extrapulmonary tuberculosis with less than 7 days of anti-tuberculosis treatment, OR other pulmonary infection (control group).
- Age ≥ 18 years
- Ability to provide informed consent
- Willingness to participate in the study
Key exclusion criteria (3 listed)
- Lack of ability to provide informed consent
- Age < 18 years
- Pregnancy
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 |
|---|---|---|
| Biomarker-guided diagnostic testsmRNA-Signature from blood; immunophenotyping from blood; MBLA from sputum, PATHFAST-LAM and EclLAM from sputum, stool, urine; CRISPR-Cas from blood; stool PCR; QuantiFERON(R)-TB Gold Plus. | Diagnostic test | Other pulmonary infections (control group), Patients with suspected TB |
Primary outcome
Feasibility of biomarker-guided diagnosis of TB - mRNA signatures
Time frame: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on mRNA signatures.
Feasibility of biomarker-guided diagnosis of TB - cellular immunology
Time frame: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on cellular immunology.
Feasibility of biomarker-guided diagnosis of TB - PATHFAST-LAM
Time frame: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on PATHFAST-LAM.
Feasibility of biomarker-guided diagnosis of TB - EclLAM
Time frame: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on EclLAM assays.
Feasibility of biomarker-guided diagnosis of TB - cell-free Mycobacterium tuberculosis DNA
Time frame: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on cell-free Mycobacterium tuberculosis DNA.
Feasibility of biomarker-guided diagnosis of TB - MBLA
Time frame: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on Mycobacterial Load Assay (MBLA).
Feasibility of biomarker-guided diagnosis of TB - stool PCR
Time frame: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on stool PCR testing.
Feasibility of biomarker-guided diagnosis of TB - composit
Time frame: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on a combination of mRNA signatures, cellular immunology, PATHFAST-LAM and EclLAM assays, cell-free Mycobacterium tuberculosis DNA analysis, MBLA, stool PCR testing, and QuantiFERON®-TB Gold Plus testing.
4 secondary outcomes
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations
Time frame: From enrollment to the end of the first week of treatment.
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations
Time frame: From enrollment to the end of the first week of treatment.
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations
Time frame: From enrollment to the end of the first week of treatment.
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations
Time frame: From enrollment to the end of the first week of treatment.
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 15 Aug 2025.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial
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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.
Christoph Lange, Prof. Dr. Dr. h.c. study chair
Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center
Marylyn Martina Addo, Prof. Dr. study chair
Institute for Infection Research and Vaccine Development, University Medical Center Hamburg-Eppendorf
Stefan Schmiedel, Dr. med. study chair
Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
1 site in 1 country: 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 1 site in Germany.
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 3 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: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 Thomas Theo Brehm, Dr. med. (+49 4537 188 2905, tbrehm@fz-borstel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of biomarker-guided diagnosis of TB - mRNA signatures (time frame: From enrollment to the end of the first week of treatment). The study lists 8 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 15 Aug 2025.