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 tools 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.

This NIH-sponsored study aims to characterize three biomarkers derived from 129Xe gas exchange MRI and understand how they change in response to interventions. The study focuses on markers derived from the interaction of 129Xe with pulmonary capillary red blood cells RBCs, specifically RBC transfer MRI, cardiogenic oscillations in 129Xe-RBC signal amplitude, and the 129Xe-RBC chemical shift. The study population includes healthy volunteers, patients scheduled to undergo transfusion or phlebotomy, patients with dyspnea, interstitial lung disease ILD, idiopathic pulmonary fibrosis IPF, non-specific interstitial pneumonias NSIP, chronic hypersensitivity pneumonitis cHP, sarcoid, chronic thromboembolic pulmonary hypertension CTEPH, and acute pulmonary embolism.

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.

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.

This clinical trial is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled study aimed at evaluating the safety, tolerability, and pharmacokinetics PK of OMN6 in patients with hospital-acquired bacterial pneumonia HABP or ventilator-associated bacterial pneumonia VABP caused by the Acinetobacter baumannii complex ABC. The purpose is to identify safe and well-tolerated doses of OMN6 and understand its behavior in the body when added to standard therapies. Participants receive either OMN6 or a placebo alongside background antibiotic treatment with meropenem and colistin. OMN6 is given in three dosing cohorts 50 mg, 100 mg, or 150 mg, each administered as three 3-hour intravenous infusions on a single day, while meropenem plus colistin treatment continues for 7 to 14 days. The comparator group receives matching placebo infusions under the same schedule plus the background antibiotics. Throughout the study, participants are closely monitored for safety and the pharmacokinetics of OMN6, including measures such as maximum concentration, time to maximum concentration, area under the curve, and half-life. Safety assessments focus on the 28 days following the single-day infusion. The trial includes randomized assignment and double-blinding to ensure unbiased evaluation. The total study duration extends until primary completion in March 2027.

Researchers are evaluating the efficacy and safety 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. This trial includes a run-in phase and a double-blinded phase 2, designed to reduce short-term mortality and improve clinical outcomes in this serious condition. The trial consists of two parts an initial open-label Run-in Phase where participants receive agenT-797 plus SOC to characterize the baseline population, followed by a randomized, double-blinded Phase 2 where participants receive either agenT-797 plus SOC or placebo plus SOC. SOC includes antimicrobial therapy and corticosteroids based on applicable guidelines. Treatments are given as intravenous infusions. Participants will be monitored from Day 1 through Day 28 for outcomes such as mortality, oxygenation support-free days, ventilator-free days, ICU-free days, new infections, antibiotic-free days, and time to hospital discharge. Additional assessments include cytokine profile changes at baseline, Day 3, Day 7, and Day 14. The study continues monitoring mortality up to Day 90. Overall, participants undergo intensive evaluations, including safety and efficacy assessments, during the study period lasting until 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 diseases effects over time.

Researchers are evaluating the LIAISON NES FLU AB, RSV & COVID-19 assay used on the LIAISON NES instrument for detecting and distinguishing influenza A, influenza B, RSV, and SARS-CoV-2 viruses in patients showing symptoms of respiratory tract infections. This test is designed to help in the differential diagnosis of these infections in a professional laboratory setting, but negative results alone should not guide patient management as they do not rule out infection. The study is interventional and involves multiple sites. The trial involves collecting clinical specimens, mainly nasal swabs, from symptomatic patients. These specimens are collected prospectively by healthcare professionals, with up to 40% possibly self-collected under supervision. Nasopharyngeal swabs may also be collected by professionals, especially in children 13 years or younger. The assay uses real-time polymerase chain reaction RT-PCR to detect viral RNA directly from dry nasal swabs without the need for nucleic acid extraction. Participants will provide nasal or nasopharyngeal swabs preserved in specific transport media, which are tested on the LIAISON NES instrument within one to two hours of collection. The study measures the diagnostic accuracy and clinical performance of the assay. Specimens are carefully stored and handled to maintain quality. The trial monitors conditions including influenza A, influenza B, RSV, and COVID-19 infections and is expected to complete by May 2025.