BridgeMD
Clinical trial in multiple hospitals to explore new ways to diagnose and monitor tuberculosis treatment
EU CTIS ID: 2025-522235-34-00
What this study is testing
To assess if Molecular Bacterial Load Assay (MBLA) and RNA Synthesis Ratio (RS-Ratio) levels measured in blood samples can be used as diagnostic and prognostic biomarkers in patients with pulmonary tuberculosis
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults, male and female, over 18 years old of age.
- Arm A: Must have a confirmed diagnosis of pulmonary tuberculosis
- Arm A: Must be about to start or currently undergoing the standard pulmonary tuberculosis regimen for pulmonary tuberculosis (2HRZE/4HR)
- Arm B: Must have a confirmed diagnosis of community-acquired bacterial pneumonia.
- Arm B: Must have any criteria that warrants in-patient management: respiratory insufficiency; PSI Class of IV or V; CURB-65 score of 1 or 2; or any other practical concern for which, at the investigators discretion, the outpatient management cannot be performed (e.g. inability to maintain oral intake; concerns about adherence to therapy; concerns about living or social situation…).
- Participant must be able to provide informed consent.
You likely can't join if
- Arm B: Any criteria that warrants Intensive Care Unit (ICU) admission: systemic inflammatory response syndrome (SIRS) or septic shock requiring vasopressor support; respiratory failure requiring mechanical ventilation; or any other clinical concern for which, at the investigators discretion, the patient should be admitted to the ICU (e.g. hypotension requiring persistent fluid support; temperature <32ºC; platelet count < 50.000; PaO2/FiO2 ratio <200…).
- Women of childbearing potential must have a negative urine pregnancy test at Screening.
- Female subject is lactating, or planning to breastfeed throughout the course of the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
- Participant is not willing or able to comply with: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- Participant has a current diagnosis of drug substance abuse.
See the full eligibility criteria
Who can join
- Adults, male and female, over 18 years old of age.
- Arm A: Must have a confirmed diagnosis of pulmonary tuberculosis
- Arm A: Must be about to start or currently undergoing the standard pulmonary tuberculosis regimen for pulmonary tuberculosis (2HRZE/4HR)
- Arm B: Must have a confirmed diagnosis of community-acquired bacterial pneumonia.
- Arm B: Must have any criteria that warrants in-patient management: respiratory insufficiency; PSI Class of IV or V; CURB-65 score of 1 or 2; or any other practical concern for which, at the investigators discretion, the outpatient management cannot be performed (e.g. inability to maintain oral intake; concerns about adherence to therapy; concerns about living or social situation…).
- Participant must be able to provide informed consent.
What rules you out
- Arm B: Any criteria that warrants Intensive Care Unit (ICU) admission: systemic inflammatory response syndrome (SIRS) or septic shock requiring vasopressor support; respiratory failure requiring mechanical ventilation; or any other clinical concern for which, at the investigators discretion, the patient should be admitted to the ICU (e.g. hypotension requiring persistent fluid support; temperature <32ºC; platelet count < 50.000; PaO2/FiO2 ratio <200…).
- Women of childbearing potential must have a negative urine pregnancy test at Screening.
- Female subject is lactating, or planning to breastfeed throughout the course of the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
- Participant is not willing or able to comply with: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- Participant has a current diagnosis of drug substance abuse.
- Participant is currently enrolled or has been enrolled in a clinical trial three months prior to inclusion in the current study.
- Any condition or situation precluding or interfering with the compliance of the protocol.
- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
- Any other condition that, in the opinion of the Investigator, may interfere with the outcome evaluation of the trial.
- Have been diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, silicosis, lung surgery, lung neoplasia or any other condition that results in lung scarring.
- Participant has metallic implants or ferromagnetic materials (e.g., pacemakers, cochlear implants); severe claustrophobia unresponsive to sedation; impaired renal function precluding gadolinium-based contrast use; or any other condition incompatible with the performance of an MRI scan.
- Participant has hypersensitivity to radiopharmaceuticals (e.g., 18F-PSMA, 18F-FDG) or tracer components such as iodine or saccharin; or any other condition incompatible with the performance of a PET scan.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.