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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

11 Feb 2026 → ongoing

Decision date (initial)

2025-09-09

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Diagnosis

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

Secondary objectives 9

1. To assess Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) technique as a potential biomarker for pulmonary tuberculosis disease progression and treatment efficacy monitoring.
2. To ascertain whether MBLA and RS-Ratio levels measured in blood samples can be correlated with MBLA and RS-Ratio levels measured in sputum samples, in patients with pulmonary tuberculosis.
3. To assess the potential of the MBLA and RS-Ratio levels measured in sputum to be used as pulmonary tuberculosis diagnostic biomarkers.
4. To assess the potential of the MBLA and RS-Ratio levels measured in sputum to be used as pulmonary tuberculosis prognostic biomarkers.
5. To assess the potential of several immune-related molecules as diagnostic biomarkers of pulmonary tuberculosis infection.
6. To assess the potential of several immune-related molecules as prognostic biomarkers of pulmonary tuberculosis infection.
7. To assess the correlation of the drug-specific pharmacokinetic profiles of the standard regimen anti-tuberculosis drugs with MBLA and RS-ratio levels measured in blood samples.
8. To assess the correlation of the drug-specific pharmacokinetic profiles of the standard regimen anti-tuberculosis drugs with MBLA and RS-ratio levels measured in sputum samples.
9. To assess the possible correlation between the MBLA and RS-Ratio levels measured in blood samples, the MBLA and RS-Ratio levels measured in sputum, the PET/MRI results, and the studied immune-related molecules levels.

Conditions and MedDRA coding

Bacterial pneumonia patients

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Adults, male and female, over 18 years old of age.
2. Arm A: Must have a confirmed diagnosis of pulmonary tuberculosis
3. Arm A: Must be about to start or currently undergoing the standard pulmonary tuberculosis regimen for pulmonary tuberculosis (2HRZE/4HR)
4. Arm B: Must have a confirmed diagnosis of community-acquired bacterial pneumonia.
5. 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…).
6. Participant must be able to provide informed consent.

Exclusion criteria 14

1. 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…).
2. Expectation that the participant will not complete his or her treatment regimen within six months.
3. 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.
4. 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.
5. 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.
6. Women of childbearing potential must have a negative urine pregnancy test at Screening.
7. Female subject is lactating, or planning to breastfeed throughout the course of the study.
8. 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).
9. Participant is not willing or able to comply with: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
10. Participant has a current diagnosis of drug substance abuse.
11. Participant is currently enrolled or has been enrolled in a clinical trial three months prior to inclusion in the current study.
12. Any condition or situation precluding or interfering with the compliance of the protocol.
13. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
14. Any other condition that, in the opinion of the Investigator, may interfere with the outcome evaluation of the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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).
2. 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).

Secondary endpoints 10

1. 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.
2. 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).
3. 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.
4. 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).
5. 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).
6. 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).
7. 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).
8. 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.
9. 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.
10. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Sponsor organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Address

Paseo De La Castellana 261

City

Madrid

Postcode

28046

Country

Spain

Scientific contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Contact name

Belen Ortiz

Public contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Contact name

Belen Ortiz

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications