Tuberculosis

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 PETCT 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 PETCT 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.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

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 devices 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 devices future use as a first-aid tool for respiratory failure outside hospitals. The total study duration and follow-up details are not specified.

Researchers are evaluating a new tuberculosis preventive treatment among adolescents and school staff who have been in close contact with active TB cases. This study compares a novel 1-month ultra-short regimen called 1H3P3 with the standard 3-month 3HR regimen, aiming to prevent latent TB infection from progressing to active tuberculosis. The trial is a phase 3, multi-center, open-label, cluster randomized controlled study conducted in school settings in China, with the goal of improving TB prevention strategies for adolescents. Participants are randomly assigned to receive either the 12-dose 1H3P3 regimen of isoniazid and rifapentine taken three times a week for one month, or the 3HR regimen of isoniazid and rifampicin taken once daily for three months. Close contacts of TB cases are screened using blood tests, chest X-rays, sputum testing, and symptom checks to rule out active TB before enrollment. The treatment period lasts either one or three months depending on the group, followed by two years of follow-up to monitor for TB development. During the study, participants will undergo regular assessments including monitoring for active tuberculosis through clinical and laboratory tests, adverse events, treatment adherence, and drug resistance if active TB occurs. The main measurement is the cumulative incidence of active TB over 24 months after treatment begins. Safety and treatment completion rates are tracked throughout. Participation involves screening, treatment administration, and periodic follow-up visits over two years to evaluate outcomes and overall TB prevention effectiveness.

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 drugs 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.