Bronchiolitis

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 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 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.

Researchers are evaluating a new multi-component score called the Readiness for EXtubation score REXs to predict when ICU patients on invasive mechanical ventilation are ready to be extubated. The process of liberation from mechanical ventilation involves weaning, readiness assessment, and extubation, with success defined as not needing invasive support within 48 hours. This study focuses on developing and analyzing REXs to help clinicians assess extubation readiness more accurately in critically ill patients. The study involves daily screening of ICU patients undergoing weaning from invasive mechanical ventilation. Data collected include clinical parameters such as arterial blood gases, ventilation settings, sedation and agitation scores, heart rate, hemoglobin levels, nutritional status, and cough strength, among others. Clinicians will anonymously enter data into an electronic case report form to develop and evaluate the REXs score. Patients prepared for extubation will have their readiness assessed using this score. Participants will be monitored during their ICU stay, with data collected on extubation success or failure at 24, 48, and 72 hours after extubation. Researchers will also track length of ICU and hospital stays and mortality outcomes. The study uses routine clinical data, with anonymization to protect patient confidentiality. Statistical methods will analyze associations between clinical factors and extubation outcomes to validate the REXs scores predictive ability. The total study duration extends until the end of 2026.

Coughing is a common and distressing symptom for people with interstitial lung disease ILD, affecting daily activities, work, and social life. This research explores a non-drug cough control therapy combined with pulmonary rehabilitation to see if it is practical and helps reduce chronic cough lasting more than eight weeks in ILD patients. The study aims to assess how well patients accept this therapy and whether it improves quality of life, cough symptoms, and fatigue compared to standard pulmonary rehabilitation alone. Participants will join a pulmonary rehabilitation program involving aerobic and strengthening exercises, disease-specific education, and self-management as usual care. Two weeks before finishing this program, they will receive four virtual sessions of 45 to 60 minutes each, focusing on cough control education and techniques. These sessions include assessing cough, learning suppression methods, breathing retraining, and reinforcing strategies to manage cough in daily life. During the study, researchers will track enrollment and attendance to measure feasibility, along with various clinical outcomes like cough severity questionnaires, fatigue scales, breathlessness ratings, and patient satisfaction interviews. The intervention is delivered online via Zoom, allowing remote participation. The total study duration averages one year, with ongoing assessments to understand the therapys impact and participants experiences.

Researchers are studying zelicapavir, a new oral medication that stops the replication of Respiratory Syncytial Virus RSV. This Phase 2 trial is evaluating zelicapavir as a potential treatment for RSV infection in children aged 28 days to 36 months who have symptoms of RSV. The study compares zelicapavir to a placebo to assess its effects and safety in both hospitalized and non-hospitalized children. Participants are randomly assigned to receive either zelicapavir oral suspension or a matching placebo once daily for 7 days. The study monitors the time it takes for RSV symptoms to completely resolve, along with other outcomes such as the severity of symptoms, viral load changes, and any hospitalizations during the study period. These assessments occur mainly from Day 1 through Day 14, with safety followed until Day 35. During the trial, caregivers and children will be assessed regularly to track symptom resolution and viral levels using specific measurement tools. Safety is carefully monitored by recording any adverse events up to Day 35. The study spans from the initial dosing period through follow-up visits, ensuring comprehensive evaluation of zelicapavirs potential in treating RSV in young children.

Researchers are evaluating the safety and immune response of the RSVpreF vaccine in adults living in India. This phase 3, multicenter, double-blinded, placebo-controlled study aims to learn how the vaccine affects adults, including those with certain stable chronic medical conditions that may increase their risk of respiratory syncytial virus RSV disease. The study is sponsored by Pfizer and focuses on prevention of RSV infection. Participants will be randomly assigned to receive either the RSVpreF vaccine or a placebo. The vaccine is given as an injection, and the study will monitor participants for local and systemic reactions within 7 days after vaccination, as well as adverse events through 1 month and serious adverse events for 3 months post-vaccination. The immune response will be measured by neutralizing antibody levels against RSV A and RSV B before vaccination and 1 month afterward. During the study, participants will be observed for safety and immune response through scheduled visits. Researchers will collect data on side effects, serious health events, and antibody levels. The study includes adults aged 18 and older who live independently and are ambulatory. Participation involves medical history review and physical exams as needed. The trial will continue until January 25, 2027, with assessments focused on vaccine safety and immune response over several months.

Researchers are evaluating the safety and immune response of a second dose of the RSVpreF vaccine in pregnant women during later pregnancies. The study also aims to understand how long the protection lasts from a single dose given during a previous pregnancy by examining blood samples from nonpregnant participants who had the vaccine before. This Phase 3 trial involves pregnant participants and their unborn babies, as well as nonpregnant participants previously vaccinated. Pregnant participants are divided into two groups one group who previously received RSVpreF in a Pfizer trial will get a second dose, and another group will be randomly assigned to receive either RSVpreF or a placebo if no prior antibody data exists. Infants born to these participants will be followed for six months to monitor safety and antibody levels. Nonpregnant participants who received RSVpreF in an earlier trial will provide blood samples to assess the durability of their immune response without receiving additional vaccine doses. Participants will undergo safety monitoring including tracking local and systemic reactions, adverse events, and serious events during pregnancy and after birth for infants. Blood tests will measure neutralizing antibodies against RSV types A and B at birth, 3 months, and 6 months. The study includes consent procedures for both pregnant participants and infants, and nonpregnant participants will have scheduled visits for blood sample collection. The total study duration extends through infant follow-up and ongoing immune response assessments.

Researchers are studying the safety and effectiveness of Deurremidevir Hydrobromide oral suspension in infants and young children aged 1 to 36 months who have respiratory syncytial virus RSV infection. This Phase III randomized, double-blind, placebo-controlled trial aims to understand how this investigational drug affects RSV symptoms and disease recovery compared to placebo. The trial is sponsored by Simcere Pharmaceutical Co., Ltd and will enroll about 498 participants. Participants will be randomly assigned in a 21 ratio to receive either Deurremidevir Hydrobromide called SIM0916 or a placebo. The drug dose is adjusted by weight, given at 20 mg per kilogram three times daily for five consecutive days, totaling 15 doses. The study monitors participants through this treatment period, comparing outcomes between the drug and placebo groups. During the study, infants and children will be regularly assessed for RSV-related clinical signs and symptoms, including wheezing and cough, using scores like the Wang Bronchiolitis Score. Researchers will track recovery times and the need for intensive care or respiratory support. Safety and symptom resolution will be followed up to day 26 after the first dose. The total participation duration covers screening, treatment, and follow-up assessments to evaluate the drugs impact and monitor safety.