Pneumonia

Researchers are evaluating whether the Breathlessness diagnostics in a Box (BiaB) tool can shorten the time to diagnosis for patients experiencing breathlessness compared to usual care. This prospective, interventional study uses a stepped-wedge cluster design in general practice settings across the Netherlands, Spain, and Portugal. The main goal is to see if BiaB speeds up diagnosis, with secondary aims to identify more cases of chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD), and to assess the tool's usability and efficiency. The study involves 45 general practice sites that start with a usual care period and sequentially transition to using the BiaB tool. Patients receive care as part of their regular visits, either through standard diagnostic procedures or with support from BiaB. No additional treatments are mandated by the study. Each site participates for 40 weeks, and data are gathered from routine clinical visits, electronic medical records, and questionnaires completed by patients and healthcare professionals. Participants attend a single study visit and may complete up to four quarterly questionnaires over a follow-up period lasting up to one year. Researchers measure the time from first presentation of breathlessness to diagnosis, the number of new COPD and CVD diagnoses, and the usability of the BiaB tool. Data are collected continuously during the usual care and intervention phases, allowing comparison of outcomes between these periods.

Researchers are studying lung mechanics during the early phase of mechanical ventilation in intensive care and during general anesthesia in surgical patients. The study aims to better understand lung compliance and transpulmonary driving pressures using a new, non-invasive PEEP-step method. This method could improve how ventilator settings are personalized to reduce lung injury and complications, addressing a gap in data collected during the critical first hours of ventilation. The study observes two groups: ICU patients receiving ventilator treatment and patients undergoing general anesthesia for surgery. In both groups, a PEEP-step method involves adjusting positive end-expiratory pressure (PEEP) up and down in one or two steps while measuring changes in lung volume and pressures. This is done directly after intubation and repeated during ventilation or surgery when clinical events occur, using specialized software that analyzes data from standard ventilator monitoring equipment. Participants will be monitored continuously during ventilator treatment or surgery. Measurements include lung elastance and transpulmonary driving pressure, collected before, during, and after respiratory care. Clinical data such as blood gases and ventilator settings are recorded without any invasive procedures. The study assesses lung function changes over time, ventilator duration, and postoperative complications, aiming to enhance ventilator therapy and patient outcomes. Total participation time varies with clinical course.

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 studying biomarkers from 129Xe gas exchange MRI to understand how they change with different medical interventions. The study focuses on interactions between 129Xe and red blood cells in the lungs. Participants include healthy volunteers and patients with conditions like interstitial lung disease, pulmonary hypertension, acute or chronic pulmonary embolism, anemia, polycythemia, and dyspnea. The study uses hyperpolarized xenon gas inhaled in multiple doses followed by breath holds, alongside oxygen administration. Participants are grouped by treatment: those undergoing transfusion or phlebotomy, patients receiving oxygen for lung-related conditions or healthy volunteers, and those recently diagnosed with acute or chronic pulmonary embolism. Treatments and responses are monitored at baseline and various follow-up points. Participants will undergo MRI scans to measure red blood cell transfer, chemical shifts after oxygen delivery, and changes in red blood cell signal oscillations before and after treatment. The study includes visits up to 3–6 months after interventions to track changes. Researchers also monitor safety and participant adherence throughout the study, which lasts until mid-2028.

Researchers are studying patients with severe pneumonia admitted to the Respiratory Intensive Care Unit (RICU) to understand the epidemiology and clinical characteristics of pneumonia caused by various factors. This observational cohort study aims to gather detailed clinical data including morbidity, mortality, risk factors, symptoms, and radiographic changes to help improve clinical care for severe pneumonia patients. The study involves patients admitted to the RICU due to pneumonia from any cause. There are no specific treatments or interventions being tested, as this is an observational study collecting data during the patients' stay. Researchers will observe respiratory support parameters, treatment options, and symptom developments during the initial days and weeks of hospitalization. Participants will be monitored for outcomes such as mortality and morbidity during their time in the RICU, with measurements taken over one year. Data on symptoms within the first 48 hours, respiratory support during the first 5 days, and treatments over 3 weeks will be collected. The study records clinical information to better understand pneumonia in this critical care setting, with participant involvement lasting as long as their hospital stay and follow-up for outcomes.

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 conducting a phase 2a, multinational, multicenter, randomized, double-blind, placebo-controlled clinical trial to study patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC). The study aims to identify safe and well-tolerated doses and assess the pharmacokinetics (PK) of the drug OMN6 in these patients. This research evaluates how OMN6 behaves in the body and its safety when added to standard therapy. Participants will be randomly assigned to one of two groups: one receiving OMN6 along with standard antimicrobial treatment using meropenem and colistin, and the other receiving a placebo combined with the same standard treatments. OMN6 is given as three intravenous infusions of either 50 mg, 100 mg, or 150 mg each, administered over three hours, all delivered on a single day. The background treatment with meropenem and colistin continues for 7 to 14 days. The study compares safety and PK profiles between these groups. During the trial, participants will be monitored for safety over 28 days following treatment. Pharmacokinetic measurements like the maximum concentration (Cmax), time to maximum concentration (Tmax), area under the curve (AUC), and half-life (t1/2) of OMN6 will be assessed within one day of dosing. Safety evaluations include observing adverse events and other clinical parameters. This thorough monitoring will help researchers understand OMN6's safety and behavior in patients with HABP or VABP caused by ABC, with the study expected to continue until March 2027.

Researchers are evaluating the safety and effectiveness of a single intravenous dose of agenT-797 combined with standard of care (SOC) compared to placebo plus SOC in adults with severe pneumonia and moderate to severe acute hypoxemic respiratory failure (AHRF). The study aims to reduce short-term mortality in this patient group and is conducted in two parts: an initial Run-in Phase and a Phase 2 randomized, double-blinded phase. All participants receive SOC management for severe pneumonia and acute respiratory distress syndrome (ARDS). In the Run-in Phase, participants receive open-label agenT-797 plus SOC to help characterize the baseline population. After this phase, participants are randomized to one of two groups in Phase 2: agenT-797 plus SOC or placebo plus SOC. Both treatments are given as intravenous infusions, and SOC includes antimicrobial therapy and corticosteroids following guidelines. Participants will be monitored from Day 1 through Day 28 for outcomes such as mortality, days without oxygen support or ventilator use, time to resolution of hypoxemia, ICU-free days, infections, antibiotic-free days, and time to hospital discharge. Additional measurements include mortality at Day 90 and changes in cytokine profiles at baseline and on Days 3, 7, and 14. The study includes safety monitoring and assessments throughout the trial period, which is expected to end in August 2027.

Researchers are evaluating the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy individuals aged 2 years and older. This phase 3 clinical trial is randomized, blinded, and parallel controlled to compare the immune response and safety profile of the study vaccine against a control vaccine. The study focuses on measuring antibody responses and monitoring adverse reactions following vaccination. Participants will receive a single dose of either the 23-valent pneumococcal polysaccharide vaccine from Aimei Vacin BioPharm or a control pneumococcal polysaccharide vaccine from Merck Sharp & Dohme Corp. The study is designed with two groups, and both vaccines are administered as one dose. The trial includes detailed safety monitoring periods immediately after vaccination and over several months to assess adverse events. During the study, participants will undergo evaluations of their antibody levels against 23 pneumococcal serotypes 30 days after vaccination, with follow-up measurements at 3 and 6 years. Researchers will also track the incidence of adverse reactions within 30 minutes, 7 days, 30 days, and serious adverse events up to 6 months after vaccination. The total duration of participation includes initial vaccination and long-term follow-up for safety and immune response assessment.

Researchers are conducting a long-term observational study to understand the characteristics and outcomes of people infected with the Omicron variant of COVID-19, including those without symptoms and those diagnosed with the disease. The study aims to explore how the virus affects various organs like the heart and lungs and to monitor changes in social and psychological health over time. Participants in this study are individuals who have tested positive for SARS-CoV-2 RNA. The study involves a follow-up period extending up to 10 years, during which participants' health status is observed without any specific treatment interventions. This extended observation allows researchers to gather detailed information on the progression and long-term impact of COVID-19. Throughout the study, participants will be monitored for changes in their clinical conditions and social and psychological well-being. The main focus is on assessing long-term outcomes and shifts in health characteristics over a decade. Data will be collected regularly to track these aspects, helping to provide a comprehensive understanding of the disease's effects over time.