Acute Respiratory Infection

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 studying the long-term effects of reducing household air pollution (HAP) from biomass fuel use on heart, lung, and immune health among women and children in semi-rural Bangladesh. The study evaluates whether a mobile phone-based behavioral change communication (mHealth BCC) intervention can increase the adoption and exclusive use of cleaner cooking fuel, Liquid Petroleum Gas (LPG). This research also investigates how lowering pollution exposure might influence immune responses to vaccines and subclinical cardiovascular and pulmonary changes. The study is a large household-level randomized controlled trial comparing two groups: one receiving the mHealth BCC intervention encouraging exclusive LPG use and a control group receiving no such intervention. Researchers will monitor personal and area levels of air pollutants like PM2.5 and black carbon before and after intervention, alongside detailed assessments including spirometry, chest X-rays, high-resolution CT scans, blood pressure, EKG, metabolic markers such as HbA1c and lipid profiles, and immune cell function. The intervention messages are delivered via mobile phone with frequency tailored to participant responses. Participants will be followed over two years with repeated measurements to assess pollutant exposure and health effects. Evaluations include lung function tests, imaging, cardiovascular markers, metabolic blood tests, and immune function assays. The study aims to provide insights into the health benefits of sustained LPG use and improved air quality. Total participation spans pre-intervention assessments through two years of follow-up, with ongoing monitoring of pollution exposure and health outcomes.

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 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 a clinical study to develop an artificial intelligence (AI)-based clustering model to personalize medicine for patients with acute respiratory failure who are admitted to the intensive care unit (ICU). The study aims to confirm patient phenotypes and compare clinical characteristics and prognosis between patients requiring advanced oxygen support and a control group without acute respiratory failure. Participants are divided into two groups: those with acute respiratory failure requiring treatment with high flow nasal cannula (HFNC), non-invasive ventilation (NIV), or mechanical ventilation (MV), and a control group who do not need these treatments. Both groups are admitted to the internal medicine ICU at Samsung Seoul Hospital and undergo the same research procedures. During the study, participants' clinical information is collected prospectively for analysis. Researchers will assess hospital mortality up to one year from admission, ICU mortality up to six months, and length of stay in both hospital and ICU. The study involves monitoring patients from admission until discharge or death, with follow-up periods varying up to one year. This observational study is sponsored by Samsung Medical Center.

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 evaluating the safety and immune response of an influenza virus split vaccine in adults aged 60 years and older through a randomized, double-blind, controlled phase I clinical trial. The study includes 120 participants divided into three groups to compare an experimental vaccine dose, a control vaccine dose, and a placebo. This research aims to understand how well the vaccine works and its side effects in this age group. Participants receive one injection of either the experimental influenza vaccine (0.7 mL), a control vaccine (0.5 mL), or a placebo, each administered into the upper arm muscle. Forty individuals are randomly assigned to each group in equal proportions. Laboratory tests are performed before vaccination and on the fourth day after vaccination to monitor immune response and safety. During the study, participants are closely monitored for any side effects for up to 30 days, including both expected and unexpected adverse events. Serious side effects are tracked for six months after vaccination. Researchers measure immune responses 30 days post-vaccination by checking antibody levels and rates of immune reaction. The study involves follow-up visits to assess safety and vaccine effectiveness, with participation lasting several months.

Researchers are conducting a randomized, double-blind, placebo and positive control Phase Ia clinical trial to evaluate the safety, tolerability, and pharmacokinetics of the SIBP-A16 injection in healthy adults aged 18 to 45. The study focuses on understanding how this injection behaves in the body and its safety profile. It involves healthy volunteers without significant medical conditions to ensure reliable results for the Respiratory Syncytial Virus (RSV) research. Participants will be assigned randomly to different groups organized in five queues, with varying doses of SIBP-A16 injection, placebo, or the active comparator Nirsevimab. The injections will be given either intramuscularly or intravenously in single doses across four different dose levels. Each queue undergoes a 14-day safety observation before the next dose level is administered based on safety committee review. During the study, participants will be monitored for adverse events, serious adverse events, and special adverse events of interest from day one up to 361 days after administration. Blood samples will be collected to measure drug levels over time, including peak concentration and time to peak. Various health assessments like physical exams, vital signs, ECGs, chest X-rays, and lab tests will be performed to ensure participant safety and measure outcomes throughout the nearly one-year follow-up.

Respiratory syncytial virus (RSV) is a common virus affecting children, especially young babies, premature infants, and those with heart or lung problems. It is a leading cause of hospitalization for children under 5 years old globally, with many severe cases and deaths occurring in low- and middle-income countries. This research evaluates the safety of an RSV vaccine called ABRYSVO given to pregnant women and how well it protects their infants from severe RSV infections during the first six months of life, particularly in African and lower-middle income countries where data is limited. Pregnant women will receive either the ABRYSVO vaccine or a placebo in a randomized, double-blind trial. The vaccine contains stabilized RSV prefusion F antigens from virus subgroups A and B. The study will enroll pregnant women at the approved gestational age for vaccination, with participants randomly assigned to receive either the vaccine or placebo in equal numbers. The trial will monitor the safety of the vaccine in mothers and infants and measure how well the vaccine prevents severe RSV lower respiratory tract infections in babies up to 180 days old. Participants will attend antenatal clinics and provide informed consent for themselves and their infants. Researchers will follow the women through pregnancy and delivery, recording any preterm births and birth weights. Infants will be monitored for RSV infections confirmed by laboratory tests, and hospitalizations due to RSV will be tracked up to six months of age. Safety assessments include monitoring adverse events in mothers and babies, with follow-up visits and telephone contacts to ensure comprehensive data collection throughout the trial 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.