Tuberculosis

Researchers are evaluating new imaging techniques in adults aged 18 to 85 with lung diseases such as asthma, emphysema, COPD, bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, and lymphangioleiomyomatosis (LAM). The study aims to develop tools for analyzing lung function and structure using hyperpolarized Xenon 129 MRI alongside pulmonary function tests. This research is supported by Western University, Canada. Participants will undergo a series of tests during a one to two-hour visit, including medical history review, vital signs measurement, full pulmonary function testing following American Thoracic Society guidelines, proton MRI, specialized 129-Xe MRI scans using chest coils, and a low-dose thoracic CT scan. The MRI procedure includes monitoring heart rate and oxygen levels, providing hearing protection, and offering supplemental oxygen as needed. These imaging and testing methods help assess lung ventilation, diffusion, and gas exchange. During the study visit, participants will complete pulmonary function tests such as spirometry, plethysmography, and diffusing capacity tests. They will undergo magnetic resonance imaging with hyperpolarized Xenon gas to visualize lung airways and anatomy, along with CT scans matched to MRI breathing maneuvers. Researchers will measure ventilation defect percent (VDP), apparent diffusion coefficients (ADC), and dissolved phase spectroscopy over five years. Participant safety is monitored throughout the visit, and the total study duration includes these assessments and follow-up measures.

Researchers are evaluating the use of 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) positron emission tomography (PET) as a noninvasive biomarker to assess lung disease and fibrosis in patients with active tuberculosis (TB). The study focuses on microbiologically confirmed TB patients to determine if 18F-FAPI-74 PET can detect fibrosis in TB lesions with high sensitivity. Participants will receive a single intravenous dose of 18F-FAPI-74 followed by a PET/CT scan performed either during the first six weeks of TB treatment or within six weeks after completing six months of TB treatment. Some patients may have a second PET/CT scan after treatment completion to compare findings. This process allows assessment of fibrosis at different stages of TB treatment. During the study, participants will undergo whole-body PET scans after injection of 18F-FAPI-74, with imaging correlated to sites of TB lesions identified on computed tomography (CT). Researchers will measure the uptake of 18F-FAPI-74 using standardized uptake values within one hour. Participants will provide informed consent and comply with scheduled visits and procedures. Safety and laboratory tests will be monitored throughout the study.

Researchers are conducting a combined retrospective and prospective cohort study at Beijing Chest Hospital to identify risk factors linked to mortality in patients with intestinal tuberculosis. The study first analyzes data collected over 15 years (2011 to 2025) from patients diagnosed and followed at the hospital. Using statistical methods, the study aims to find factors like age, disease severity, other illnesses, and treatment adherence that may impact survival. The study includes two groups: a retrospective cohort of patients diagnosed between 2011 and 2025 whose historical medical records and follow-up data are reviewed, and a prospective cohort of newly diagnosed patients enrolled after 2026 who will be followed over time. Data collected include demographics, clinical symptoms, laboratory tests, treatment details, and mortality outcomes to verify and supplement the findings from the first phase. Participants will provide clinical information through medical records or ongoing follow-up visits, allowing researchers to monitor their health status and treatment responses. Outcome measures focus on all-cause mortality, tracked over 15 years for the retrospective group and for 3 years from enrollment for the prospective group. This research helps improve understanding of factors influencing survival and may guide better management strategies for intestinal tuberculosis patients.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

Researchers are investigating a combination of zoledronic acid and interleukin 2 that boosts a specific immune cell subset called Vb32Vb42 T cells, alongside standard anti-tuberculosis chemotherapy, to treat multidrug-resistant tuberculosis (MDR-TB). MDR-TB is a serious form of drug-resistant TB with limited cure rates despite current treatments. This study explores immunotherapy as a new approach to help patients who respond poorly to existing drug regimens. Participants receive treatment following WHO guidelines for drug-resistant TB. One group gets standard MDR-TB treatment plus intravenous zoledronic acid three times and subcutaneous recombinant human interleukin 2 ten times over six months. The other group receives only the standard MDR-TB treatment regimen. The immunotherapy aims to expand and activate Vb32Vb42 T cells to better fight the infection. During the study, researchers monitor participants for changes in sputum smear and culture results, with an average follow-up of 24 months. They also assess lung changes through radiographic imaging over this period. The study collects data on immune response and treatment effectiveness while following participants closely to evaluate safety and disease progression from start to completion.

Researchers are investigating extrapulmonary tuberculosis (EPTB), a form of tuberculosis that affects organs other than the lungs. This observational study involves adults newly diagnosed with EPTB and aims to improve clinical management by developing specific biomarkers for diagnosis and treatment monitoring. The study also includes pulmonary TB patients and healthy controls to support laboratory analyses and comparisons. The research is conducted across multiple centers in Germany, addressing the rising proportion of EPTB cases and challenges in treatment evaluation. Participants receive standard clinical care while clinical data and biological samples such as blood and urine are collected throughout their treatment. The study has several groups based on the extent of sample collection, including patients with full and partial samples and healthy controls. Data collection points occur at diagnosis, during treatment at 4 weeks, 3 months, and 6 months, and after treatment completion, with additional follow-up for longer treatments. Biomarker analyses include gene expression and T-cell assays, with samples stored centrally for detailed laboratory studies. During study visits, routine clinical assessments such as symptom evaluation, laboratory tests, and imaging (ultrasound, CT, MRI) are performed. Researchers collect sputum and urine samples for microbiological testing and gather data using case report forms transferred to an electronic database. Outcomes focus on blood biomarkers for diagnosis and treatment response, correlated with clinical signs like symptom improvement and weight gain. This comprehensive approach aims to better predict treatment success and guide future EPTB care strategies over a two-year period.

Acute respiratory failure is a serious medical emergency that can quickly lead to death without prompt treatment. Researchers are evaluating a new portable device designed to provide Continuous Positive Airway Pressure (CPAP) support outside of hospital settings. This device aims to be easy to use by non-medical individuals and to improve outcomes for patients experiencing respiratory failure. The study will test the device's effectiveness and usability in two groups: healthy elderly adults who will self-apply the device, and hospitalized patients with mild oxygenation impairment. The device is designed to deliver positive end-expiratory pressure (PEEP) between 4 and 7.5 cmH2O, and its performance will be assessed in real-world clinical settings across three hospitals. Participants will be monitored for up to 2 hours during device use, with assessments including how easy the device is to use, duration of proper pressure delivery, battery consumption and duration, and changes in blood oxygen levels (SpO2). The study will collect data to support the device's future use as a first-aid tool for respiratory failure outside hospitals. The total study duration and follow-up details are not specified.

Pulmonary tuberculosis (TB) remains a major global health challenge, especially in China, which has a high burden of both drug-susceptible and drug-resistant TB cases. Researchers are evaluating a new ultra-short-course treatment regimen called PAN-TB that aims to be effective for all active TB types. This regimen seeks to simplify treatment, reduce costs, shorten treatment duration to 2-3 months, and improve safety and success rates compared to standard care. The study compares multiple treatment regimens including a 2-month bedaquiline, linezolid, sitafloxacin, and pyrazinamide (BLSZ) regimen with possible extensions up to 13 weeks, a standard 6-month regimen using isoniazid, rifampicin, pyrazinamide, and ethambutol, and a 6-month bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) regimen with potential extension to 9 months if needed. Each treatment arm is tailored for either drug-susceptible or drug-resistant TB, and adjustments are made based on sputum smear or culture results and clinical symptoms. Participants will undergo regular follow-up visits for up to 18 months to monitor treatment outcomes and safety. Assessments include sputum culture conversion, clinical symptom evaluation, chest imaging, laboratory tests, and adverse event monitoring. The primary outcomes focus on unfavorable outcomes at 12 months and safety at 2 months, with additional secondary outcomes tracking longer-term treatment success and side effects. The study also aims to identify new biomarkers linked to treatment responses throughout the therapy.

Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drug's safety profile. Participants will be divided into two main groups: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are evaluating different doses of JDB0131 benzenesulfonate tablets compared with delamanid combined with bedaquiline, linezolid, levofloxacin or moxifloxacin, and clofazimine in patients with drug-resistant tuberculosis, including rifampicin-resistant strains. This phase 2b, multicenter, randomized, open-label clinical study aims to assess the efficacy, safety, and how the body processes these treatments over an 8-week period. Participants will be randomly assigned to one of three groups based on their fluoroquinolone resistance status. All groups receive bedaquiline, linezolid, and either levofloxacin or moxifloxacin or clofazimine for 8 consecutive weeks. Two groups receive different doses of JDB0131 (100 mg or 200 mg twice daily), while the third group receives delamanid. Dosages of accompanying drugs are adjusted by body weight and other factors as specified. During the study, participants will undergo regular assessments including sputum culture tests to measure treatment effectiveness, monitoring of vital signs, electrocardiograms, laboratory tests for safety, and pharmacokinetic evaluations to understand drug levels in the body. Adverse events and medication usage will be tracked throughout the 8-week treatment. The primary outcome is the percentage of patients achieving sputum culture conversion during and after treatment.