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NCT Number: NCT07125274

Sputum-free Diagnostis of TB

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

Hamburg, 20246, Germany

Location status: Recruiting

Location contact

Thomas Theo Brehm, Dr. med.

CONTACT

[email protected]

+49 152 2282 3999

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • Lack of ability to provide informed consent
  • Age < 18 years
  • Pregnancy

Treatment and study plan

Biomarker-guided diagnostic tests

Diagnostic 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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.

Secondary outcomes

  1. Exploratory Analysis of Biomarker Profiles and Their Clinical Associations

    Time frame: From enrollment to the end of the first week of treatment.

    Degree of correlation between the different biomarkers.

  2. Exploratory Analysis of Biomarker Profiles and Their Clinical Associations

    Time frame: From enrollment to the end of the first week of treatment.

    Qualitative and quantitative characterization of differences in biomarker profiles between pulmonary and extrapulmonary tuberculosis.

  3. Exploratory Analysis of Biomarker Profiles and Their Clinical Associations

    Time frame: From enrollment to the end of the first week of treatment.

    Qualitative and quantitative characterization of sex-specific differences in biomarker expression patterns.

  4. Exploratory Analysis of Biomarker Profiles and Their Clinical Associations

    Time frame: From enrollment to the end of the first week of treatment.

    Degree of correlation between biomarkers and disease severity, as well as their potential prognostic value.

Study contacts

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

Niklas Köhler, Dr. med.

CONTACT

[email protected]

+49 4537 188 8080

Thomas Theo Brehm, Dr. med.

CONTACT

[email protected]

+49 4537 188 2905

Sponsors and collaborators

Lead sponsor

Research Center Borstel

Other

Registry information

Official study title

Biomarker-guided Diagnosis of Tuberculosis

Acronym: TB_Diagnostics

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

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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