Clinical trial in multiple hospitals to explore new ways to diagnose and monitor tuberculosis treatment

Trial details

Who runs it

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Trial code

EU 2025-522235-34-00

Record updated

2026. augusztus 3.

Original description

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 tuberculosisRead full original descriptionShow less

Low Intervention, Open, Multicentric, Phase IV Exploratory Clinical Trial to evaluate new biomarkers for the diagnosis and treatment monitoring of tuberculosis

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

Inclusion: 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.

Exclusion: 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; 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…); 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; 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.

EU CTIS 2025-522235-34-00