2025-522235-34-00招募中4 期
Low Intervention, Open, Multicentric, Phase IV Exploratory Clinical Trial to evaluate new biomarkers for the diagnosis and treatment monitoring of tuberculosis
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz4 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年9月9日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- 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).
研究概览
简要总结
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
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Low Intervention, Open, Multicentric, Phase IV Exploratory Clinical Trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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…).
- •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.
- •Expectation that the participant will not complete his or her treatment regimen within six months.
- •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.
- •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.
结局指标
主要结局
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).
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).
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).
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).
次要结局
- 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.
- 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).
- 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.
- 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).
- 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).
- 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).
- 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).
- 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.
- 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.
- 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.
研究者
Belen Ortiz
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
研究点 (4)
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