Menu
Recruiting NCT07125274

Sputum-free Diagnostis of TB

— Observational Tuberculosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biomarker-guided diagnostic tests.
Who it may be relevant to
Registry conditions: Tuberculosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Biomarker-guided Diagnosis of Tuberculosis

Overview

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.

Interventions

  • Diagnostic test Biomarker-guided diagnostic tests
    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 outcome measures

  • Feasibility of biomarker-guided diagnosis of TB - mRNA signatures [Time frame: From enrollment to the end of the first week of treatment]
  • Feasibility of biomarker-guided diagnosis of TB - cellular immunology [Time frame: From enrollment to the end of the first week of treatment]
  • Feasibility of biomarker-guided diagnosis of TB - PATHFAST-LAM [Time frame: From enrollment to the end of the first week of treatment]
  • Feasibility of biomarker-guided diagnosis of TB - EclLAM [Time frame: From enrollment to the end of the first week of treatment]
  • 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]
  • Feasibility of biomarker-guided diagnosis of TB - MBLA [Time frame: From enrollment to the end of the first week of treatment]
  • Feasibility of biomarker-guided diagnosis of TB - stool PCR [Time frame: From enrollment to the end of the first week of treatment]
  • Feasibility of biomarker-guided diagnosis of TB - composit [Time frame: From enrollment to the end of the first week of treatment]
Secondary outcome measures (4)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Ce — Hamburg

Identifiers

NCT: NCT07125274 · TBDiagnostics2025-101457-BO-ff

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗