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Study evaluating blood biomarkers for diagnosis and monitoring treatment in patients with pulmonary tuberculosis using isoniazid, rifampicin, pyrazinamide, and ethambutol combination

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on pulmonary tuberculosis and bacterial pneumonia. The research aims to evaluate new ways to diagnose and monitor tuberculosis using blood sample tests. The study will examine two specific measurements: the Molecular Bacterial Load Assay and RNA Synthesis Ratio, which are tests that may help identify and track the progress of tuberculosis infection.

Participants diagnosed with tuberculosis will receive standard treatment consisting of two medication combinations. The first combination includes isoniazid, pyrazinamide, rifampicin, and ethambutol hydrochloride taken as tablets for two months. This is followed by a second combination of isoniazid and rifampicin tablets for four months. Throughout the treatment period, researchers will collect blood samples to measure various indicators of disease activity.

The study will also use advanced imaging techniques including PET/MRI scans to monitor how the disease responds to treatment. These scans create detailed pictures of the lungs and can show how the infection changes over time. Blood and sputum (mucus coughed up from the lungs) samples will be collected to measure various substances that might indicate how well the treatment is working.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial diagnosis and group assignment

    You will be assigned to one of two groups: Group A if you have pulmonary tuberculosis, or Group B if you have bacterial pneumonia.

    For Group A, you must either be about to start or currently receiving standard tuberculosis treatment.

    For Group B, you must require hospital treatment due to respiratory problems or other medical concerns.

  2. Step 2

    Medication regimen - Group A

    If you are in Group A, you will receive the standard tuberculosis treatment consisting of two phases:

    First phase (2 months): Daily Rimstar tablets containing isoniazid, rifampicin, pyrazinamide, and ethambutol hydrochloride

    Second phase (4 months): Daily Rifinah tablets containing isoniazid and rifampicin

  3. Step 3

    Sample collection

    Throughout the study, medical staff will collect:

    Blood samples to measure specific markers related to tuberculosis

    Sputum samples (fluid from your lungs) for bacterial testing

    These samples will be used to test new methods for diagnosing and monitoring tuberculosis

  4. Step 4

    Imaging procedures

    You will undergo PET/MRI scanning at different stages of your treatment

    These images will help monitor how your infection responds to treatment

  5. Step 5

    Treatment monitoring

    Your progress will be tracked using several methods:

    Regular assessment of bacteria levels in your samples

    Monitoring of your clinical symptoms

    Evaluation of your response to medication

  6. Step 6

    Study duration

    The study period runs from September 2025 to October 2026

    Your individual participation duration will depend on your treatment needs and response

Who can join the trial?

9 criteria

  • Must be an adult aged 18 or older, either male or female
  • For patients in Group A:
    • Must have a confirmed diagnosis of pulmonary tuberculosis (infection in the lungs)
    • Must be either about to begin or currently receiving standard tuberculosis treatment (a combination of medications taken over 6 months)
    • For patients in Group B:
      • Must have a confirmed diagnosis of community-acquired bacterial pneumonia (lung infection developed outside of hospital)
      • Must require hospital admission due to at least one of these conditions:
        • Breathing difficulties
        • Severe illness score (PSI Class IV or V)
        • Moderate illness score (CURB-65 score of 1 or 2)
        • Other concerns that prevent outpatient treatment, such as inability to take oral medications or social situation concerns
        • Must be able to understand and provide informed consent (agreement to participate after understanding study details)

Who cannot join the trial?

14 criteria

  • Age under 18 years or over 65 years old
  • Current pregnancy or breastfeeding
  • History of bacterial pneumonia (infection of the lungs caused by bacteria) in the past 3 months
  • Currently taking antibiotics for any condition
  • Inability to provide blood samples
  • Severe health conditions that could affect the study results
  • Participation in other clinical trials within the last 30 days
  • Unable to provide informed consent
  • Known allergies to medications used in the study
  • Significant liver or kidney problems
  • Immune system disorders that could affect the test results
  • History of blood disorders that could interfere with blood sampling
  • Mental health conditions that could affect ability to follow study procedures
  • Unable to attend follow-up visits as required by the study schedule
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Investigated drugs

Based on the provided trial information, this appears to be an observational study focused on biomarker testing rather than testing specific medications. The trial evaluates: Molecular Bacterial Load Assay (MBLA) - This is a diagnostic test that measures the amount of tuberculosis bacteria in blood samples. It's not a medication but rather a laboratory testing method used to help diagnose and monitor tuberculosis infection. RNA Synthesis Ratio (RS-Ratio) - This is another diagnostic test that measures certain patterns in the genetic material of tuberculosis bacteria in blood samples. Like MBLA, it's not a medication but a testing method to help monitor how well tuberculosis treatment is working. These are diagnostic tools rather than medications, and the trial aims to evaluate their effectiveness in diagnosing and monitoring tuberculosis treatment.

What is already known about the treatment

Since no specific medications are mentioned in the provided trial data, I cannot create medication descriptions in the requested format. The trial appears to be focused on evaluating diagnostic biomarkers (Molecular Bacterial Load Assay and RNA Synthesis Ratio) for tuberculosis diagnosis and monitoring, rather than testing specific medications. If you would like medication descriptions, please provide data that includes specific drug names or therapeutic agents being studied.

Investigated diseases

  • Bacterial Pneumonia

    An infection that occurs when bacteria enter the lungs and cause inflammation in the air sacs. The air sacs may fill with fluid or pus, causing cough, fever, and difficulty breathing. The condition develops when bacteria multiply in the lungs, leading to inflammation and accumulation of fluids in the affected areas.

  • Pulmonary Tuberculosis

    A bacterial infection caused by Mycobacterium tuberculosis that primarily affects the lungs. The infection typically develops gradually, with bacteria slowly multiplying in the lungs and creating small patches of inflammation. As the disease progresses, it can create small cavities in the lung tissue. The infection can cause the affected person to experience persistent cough, chest pain, and fatigue.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522235-34-00Protocol codeBIOMARK4TBEstimated enrolment75 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

sourced from the EU Clinical Trials Register and site verification

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