Sputum-free Diagnostis of TB

NCT07125274 | Recruiting

• 1 other identifier: TBDiagnostics2025-101457-BO-ff
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

TB; diagnostics; sputum; sputum-free; transcriptomic; pathfast; CRISPR; stool; PCR

Outcome Measures

Primary Outcomes (8)

• Feasibility of biomarker-guided diagnosis of TB - mRNA signatures

  Assessment of the feasibility of tuberculosis (TB) diagnostics based on mRNA signatures.

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  From enrollment to the end of the first week of treatment

Secondary Outcomes (4)

• Exploratory Analysis of Biomarker Profiles and Their Clinical Associations

  From enrollment to the end of the first week of treatment.

• Exploratory Analysis of Biomarker Profiles and Their Clinical Associations

  From enrollment to the end of the first week of treatment.

• Exploratory Analysis of Biomarker Profiles and Their Clinical Associations

  From enrollment to the end of the first week of treatment.

• Exploratory Analysis of Biomarker Profiles and Their Clinical Associations

  From enrollment to the end of the first week of treatment.

Study Arms (2)

Patients with suspected TB

Diagnostic Test: Biomarker-guided diagnostic tests

Other pulmonary infections (control group)

Diagnostic Test: Biomarker-guided diagnostic tests

Interventions

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.

Other pulmonary infections (control group); Patients with suspected 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

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Research Center Borstel: lead

Study Sites (1)

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

Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Christoph Lange, Prof. Dr. Dr. h.c.

  Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center

  STUDY CHAIR

• Marylyn Martina Addo, Prof. Dr.

  Institute for Infection Research and Vaccine Development, University Medical Center Hamburg-Eppendorf

  STUDY CHAIR

• Stefan Schmiedel, Dr. med.

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

  STUDY CHAIR

Central Study Contacts

Thomas Theo Brehm, Dr. med.

CONTACT

+49 4537 188 2905; tbrehm@fz-borstel.de

Niklas Köhler, Dr. med.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: August 15, 2025
• Study Start: June 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting mid 2027

Locations

DE (1)