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

Prior treatment

• 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.

Other illness

• 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.

Lab values

• 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.

Other

• 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.

• 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.