Application of Ventilator-Associated Events (VAE) in Ventilator-Associated Pneumonia (VAP) Notified...
Ventilator-Associated PneumoniaHealthcare-Associated Pneumonia1 moreMulticentric observational prospective cohort study in 15 (fifteen) hospitals representing all Brazilian regions. The main objective of this project is to evaluate the incidence of Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria for VAP versus VAE criteria defined by the National Healthcare Safety Network (NHSN). The diagnostic accuracy of the two criteria for identifying VAP will also be compared, characterizing other events associated with mechanical ventilation that are not VAP, when applicable. The study also aims to adjudicate ventilator-associated pneumonias reported to ANVISA using current epidemiological diagnostic criteria.
Comparison of the Frequency of Ventilator-Associated Pneumonia in Intubated Patients Followed Up...
Ventilator-associated PneumoniaBased on the hypothesis that keeping the endotracheal cuff pressure in the optimum range will reduce the incidence of vip, we aimed to compare the Manual (intermittent) measurement method with the Automatic (continuous) measurement method in reducing the incidence of vap.
AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
Community-acquired PneumoniaThis is an international, open-label, stratified randomized controlled trial with Bayesian adaptive stopping rules to compare the effects of therapeutic-dose heparin vs. usual care pharmacological thromboprophylaxis on outcomes in patients admitted to hospital with community acquired pneumonia (CAP).
Effect of High Dose Intravenous Vitamin C in Severe Pneumonia
PneumoniaThis trial is a multicenter, randomized, double-blind, two-arm, parallel-group, placebo-controlled trial to investigate the effect of high dose intravenous (IV) Vitamin C as an adjunct to the standard of care for patients with severe pneumonia versus placebo in ICU.
A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy...
PneumoniaBacterial3 moreThis is a Phase 2 clinical study to support the use of AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of 3 different dose levels of AFX3772 compared with PCV13. Infants approximately 2 months of age will be enrolled and receive 4 doses of study vaccine over 8 protocol-defined visits spanning a duration of approximately 18 to 21 months. Part 1 is the dose escalation, lead-in portion of the study in which infants at each dose level will be randomized 3:1 in sequential cohorts of increasing doses of AFX3772 or PCV13. Enrollment in Cohorts 2 and 3 will proceed following Data Monitoring Committee (DMC) review of cumulative safety and tolerability data from preceding cohorts. Following completion of DMC review of safety and tolerability data for the cohorts enrolled in Part 1, additional infants will be enrolled and randomized equally to receive either PCV13 or AFX3772 at different dose levels approved for evaluation in Part 2.
Effects of Bronchial Segmental Endotoxin Instillation in Humans
Acute Lung InflammationBackground: - When bacteria enter the lungs, serious infections can occur. Researchers want to learn more about the process of inflammation in the lungs by studying lung cells and the products that they make. Lung cells are influenced by infections, smoking, and molecules made within the body. Researchers also want to learn more about one of these molecules, called microRNA (or micro ribonucleic acid). Objective: - To better how the body responds to infection. Also, to understand which cells in the lung secrete microRNA and how they may influence other lung cells. Eligibility: - Healthy, non-smoking adults ages 18-45. Design: Participants will be screened with a medical history and physical exam. They will have blood and urine tests and an electrocardiogram. Participants will have blood drawn from an arm vein. They will have an intravenous catheter (small plastic tube) placed in a vein. All participants will have bronchoscopy with bronchoalveolar lavage. They will be numbed with medicine. A thin flexible tube will be placed through the nasal passages or the mouth into the airways of the lung. Some participants will have bronchoscopy with bronchoalveolar lavage (rinsing the airways with salt water) in order to obtain cells from lung. The water will then be suctioned out. Some participants will have two bronchoscopies; during the first procedure, endotoxin, a molecule found in bacteria is squirted into a small portion of the lung. Endotoxin is a molecule that acts like an infection but isn t one. After 6 to 48 hours, bronchoscopy with with bronchoalveolar lavage will be done to look at the lung s response to endotoxin. Participants heart rhythm and rate, temperature and blood oxygen level will be monitored during the procedures. Participants will be called the next day to see how they are feeling.
Evaluation of a Functional Lymphocyte Test (QuantiFERON Monitor®) as a Prognostic Marker for Acute...
PneumoniaLower respiratory infections, or pneumonia, remain the third leading cause of death worldwide, despite progress in vaccinating at-risk populations and improved resuscitation techniques. Research shows that immune defences are weakened during severe infections. This immune weakening could alter resistance to bacterial infection and facilitate death, but also facilitate the onset of secondary infections. Through this study, investigators wish to evaluate a biomedical test (derived from a blood sample - Quantiferon Monitor test), aimed at measuring the immune response of certain immune cells (lymphocytes). The objective of the study is to determine whether this test can predict the occurrence of death during pneumonia. If this hypothesis is verified, it would make it possible to use this test as a marker to identify patients at risk of death, and would open up new therapeutic prospects in order to provide patients with severe pneumonia with a treatment that stimulates their immune defences. Recently, COVID-19 has changed the epidemiology and management of acute community-acquired pneumonia. Numerous studies, including some recently published ancillary studies of the Lymphony study, suggest that a deregulated immune response could contribute to the poor patient prognosis. Different determinants could contribute to this. Endotoxemia reflects the elevation of plasma LPS concentrations and represents a major Gram-negative determinant. Endotoxemia also seems to be observed during infectious pneumopathies, even though the main causative agents are devoid of LPS. The genesis of this endotoxemia and its intensity could reflect a digestive bacterial translocation phenomena that is correlated with severity. Concerning the secondary objectives of the COVITOXEMIA ancillary study: the main hypothesis is that severe pneumopathies related to SARS-CoV2- are associated with endotoxemia. Furthermore, early work comparing the immune response during severe SARS-CoV-2-related lung disease to immune responses of other origins demonstrated higher concentrations of CXCL10, GM-CSF, and VCAM1 during COVID-19. Since these 3 markers mediate activation (GM-CSF), chemotaxis (CXCL10), and diapedesis (VCAM-1) of myeloid cells, these results suggest an important role for their activation during COVID-19, especially of neutrophils. Regarding the secondary objectives of the NETCovid study: In an attempt to better characterize the specific pathogenesis of COVID-19, which contributes to the poor outcome, the objective is to compare the neutrophil immune response between patients with and without SARS-CoV-2 related severe pneumonia, considering the levels of biomarkers of activation (including NETose), degranulation and chemotaxis of neutrophils.
The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines on Immunogenicity and Carriage...
Pneumococcal InfectionStreptococcus Pneumoniae Infection2 moreBefore the introduction of pneumonia vaccines in 2000, between 700,000 - 1 million children died each year as a result of infection with the bacteria Streptococcus pneumoniae and the resulting diseases, namely, meningitis, sepsis and pneumonia. Most of the deaths were in Africa and Asia. Where the vaccines have been introduced, they have been highly effective and have already reduced disease. However, at 10 USD per child, they are not affordable to most low-income countries without financial support from Gavi, the Vaccine Alliance. This project aims to assess whether lower doses of the two commercially available pneumonia vaccines can protect Kenyan infants as well as the full dose. The results could be used to increase the affordability of the pneumonia vaccine, and enable delivery of the vaccine to continue in the absence of Gavi support.
TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
Hematopoietic Stem Cell Transplant (HSCT)Diffuse Alveolar Hemorrhage3 moreHematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited. This is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic (alloHSCT) or autologous hematopoietic stem cell transplantation (autoHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.
Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.
COVID-19 PneumoniaThis was a randomized, double-blind, placebo-controlled parallel study.