ISONIAZID, RIFAMPICIN for Pulmonary tuberculosis | Community-acquired bacterial pneumonia

Inclusion criteria

• {"criterion_text":"- Adults, male and female, over 18 years old of age.\n- Arm A: Must have a confirmed diagnosis of pulmonary tuberculosis\n- Arm A: Must be about to start or currently undergoing the standard pulmonary tuberculosis regimen for pulmonary tuberculosis (2HRZE/4HR)\n- Arm B: Must have a confirmed diagnosis of community-acquired bacterial pneumonia.\n- 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…).\n- Participant must be able to provide informed consent."}

Exclusion criteria

• {"criterion_text":"- 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…).\n- Participant has a current diagnosis of drug substance abuse.\n- Participant is currently enrolled or has been enrolled in a clinical trial three months prior to inclusion in the current study.\n- Any condition or situation precluding or interfering with the compliance of the protocol.\n- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.\n- Any other condition that, in the opinion of the Investigator, may interfere with the outcome evaluation of the trial.\n- Expectation that the participant will not complete his or her treatment regimen within six months.\n- 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.\n- 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.\n- 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.\n- Women of childbearing potential must have a negative urine pregnancy test at Screening.\n- Female subject is lactating, or planning to breastfeed throughout the course of the study.\n- 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).\n- Participant is not willing or able to comply with: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures."}

Primary endpoints

• {"endpoint_text":"- Diagnostic accuracy (sensitivity and specificity) of the MBLA and RS-Ratio levels measured in blood samples to detect active pulmonary tuberculosis compared to non-TB controls (Arm B patients), based on reference standards (sputum culture or GeneXpert results).\n- Correlation between the evolution of longitudinal changes of the MBLA and RS-Ratio levels measured in blood samples and established indicators of pulmonary tuberculosis progression (quantitative bacterial load measured by serial sputum culture or molecular assays, radiological findings or clinical progression indicators, whichever is available).","definition_or_measurement_approach":"Primary endpoints measured by: (1) diagnostic accuracy (sensitivity and specificity) of MBLA and RS-Ratio in blood versus reference standards (sputum culture or GeneXpert); (2) correlation of longitudinal MBLA and RS-Ratio blood levels with established progression indicators (quantitative serial sputum culture or molecular assays, radiological findings, or clinical progression indicators)."}

Secondary endpoints

• {"endpoint_text":"- Correlation between the evolution of PET/MRI imaging patterns in early and late-stage pulmonary tuberculosis and the evolution of PET/MRI imaging patterns in bacterial pneumonia.\n- Correlation between the evolution of PET/MRI imaging patterns in early and late-stage pulmonary tuberculosis and established indicators of pulmonary tuberculosis progression (quantitative bacterial load measured by serial sputum culture or molecular assays or clinical progression indicators, whichever is available).\n- Correlation between MBLA/RS-Ratio levels measured by droplet digital polymerase chain reaction (ddPCR) in blood and MBLA/RS-Ratio levels measured in sputum samples.\n- Diagnostic accuracy (sensitivity and specificity) of the MBLA and RS-Ratio levels measured in sputum samples to detect active pulmonary tuberculosis compared to non-TB controls (Arm B patients), based on reference standards (sputum culture or GeneXpert results).\n- Correlation between the evolution of longitudinal changes of the MBLA and RS-Ratio levels measured in sputum samples and established indicators of pulmonary tuberculosis progression (quantitative bacterial load measured by serial sputum culture or molecular assays, radiological findings or clinical progression indicators, whichever is available).\n- Diagnostic accuracy (sensitivity and specificity) of several immune molecules’ (refer to Section 13.2: Appendix 2: Laboratory Tests for the complete list of immunological molecules analyzed) levels to detect active pulmonary tuberculosis compared to non-TB controls (Arm B patients), based on reference standards (sputum culture or GeneXpert results).\n- Correlation between the evolution of longitudinal changes of several immune molecules’ (refer to Section 13.2: Appendix 2: Laboratory Tests for the complete list of immunological molecules analyzed) levels and established indicators of pulmonary tuberculosis progression (quantitative bacterial load measured by serial sputum culture or molecular assays, radiological findings or clinical progression indicators, whichever is available).\n- Correlation between the evolution of longitudinal changes of the MBLA and RS-Ratio levels measured in blood samples and the standard regimen anti-tuberculosis drugs’ pharmacokinetic profile.\n- Correlation between the evolution of longitudinal changes of the MBLA and RS-Ratio levels measured in sputum samples and the standard regimen anti-tuberculosis drugs’ pharmacokinetic profile.\n- Correlation between the evolution of longitudinal changes of the MBLA and RS-Ratio levels measured both in blood and in sputum, the evolution of the studied immune related molecules’ levels and the evolution of PET/MRI imaging patterns throughout the course of pulmonary tuberculosis infection.","definition_or_measurement_approach":"Secondary endpoints measured by correlations between MBLA/RS-Ratio and PET/MRI imaging, ddPCR measures, sputum-based assays, immune molecule levels, and pharmacokinetic profiles; diagnostic accuracy assessments versus reference standards (sputum culture or GeneXpert) where specified. Specific laboratory methods (e.g., ddPCR) and imaging (PET/MRI) are used as described."}

Spain

Earliest CTIS Part Ii Submission Date

25-06-2025

Latest Decision Or Authorization Date

09-09-2025

Processing Time Days

76

Number Of Sites

4

Number Of Participants

75

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain