View clinical trials related to Influenza, Human.
Filter by:Influenza A (H1N1) v2009 infection was responsible throughout the world of viral pneumonia and severe pulmonary edema requiring rescue therapeutics such as extracorporeal oxygenation. To date, no data exist on the outcome of patients having developed acute respiratory distress syndrome (ARDS) due to influenza A (H1N1) v2009, and in particular in patients with very severe lung injury requiring extracorporeal oxygenation. Although data exist on long-term outcome of survivors of ARDS, the patients included in the observational studies were heterogeneous with various underlying disease. Moreover, no study compared the outcome of survivors of ARDS according to the need or not of extracorporeal oxygenation. We therefore conducted this prospective case-control study to compare the long term pulmonary and extra pulmonary function in 2 groups of patients, one with severe ARDS due to H1N1 requiring extracorporeal oxygenation (case), and the second with ARDS due to H1N1 but without need for extracorporeal oxygenation (control). Eighteen case patients with inclusion and without non-inclusion criteria were selected from our national registry, and 32 controls (with inclusion and exclusion criteria) were matched on age, sex, and body mass index. All 48 patients will be contacted and asked to participate. Patients will be evaluate at least 9 months after ICU discharge, looking for health-related quality of life, measured by the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36), post traumatic stress disorder, assessed by the Impact of Event Scale Anxiety, and depression, assessed by the Hospital and Depression Score. Pulmonary function testing, including VO2 max test on a static bike will be performed. Muscle weakness will be clinically evaluated by the medical council research (MRC) test, with an additional electromyography if the result of the test was <48/60. A CT-scan will be performed, looking for lung abnormalities (fibrosis...). Albumin and prealbumin will be measured to evaluate the nutritional status. Primary outcome measurement is carbon monoxide diffusion capacity. The primary hypothesis is that patients with extracorporeal oxygenation will have a carbon monoxide diffusion capacity lower than patients without extracorporeal oxygenation (15% difference between groups). Inclusion of 13 patients in the case group and 26 patients in the control group will allow testing this hypothesis with a statistical power of 80% (standard deviation 15%). Secondary outcome measures will be the quality of life, the presence or not of post-traumatic stress disorders, of anxiety and/or depression, the results of pulmonary function testing, of the CT-scan, and of muscle testing. All results will be compared in patients with and without extracorporeal oxygenation.
The purpose of this study is to investigate the safety, tolerability and immunogenicity of ascending doses of a novel, universal flu vaccine, in healthy volunteers.
This is a specimen collection protocol designed with the purpose of understanding the immune responses to influenza in children and adult subjects through collection of blood specimens and influenza medical history data. This protocol will allow the investigators to evaluate influenza-specific immune responses to a variety of influenza strains in a broad age range of the U.S. population early and late in the 2010-2011 influenza season. Immune responses will be evaluated using blood samples. The underlying hypothesis for this protocol is that the detailed characterization of immune responses to influenza in subjects from different age groups will further the understanding of immune responses cross-reactivity and advance development of influenza vaccines that are cross-reactive against old, new and re-emerging influenza strains.
The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age Primary Objective: - To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV. - To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2
This is a study in healthy adult volunteers to assess the bioequivalence of over-encapsulated oseltamivir capsules to commercially available oseltamivir capsules. Both formulations will be administered in the fasting state.
This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of age who are eligible for study participation will be enrolled in the trial. It is expected that 10 subjects will be screened to obtain 7 subjects who will be eligible for study participation. The primary objective is to determine the frequency and severity of local and systemic adverse events of vaccine. The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.
The investigators purpose is to prospectively characterize influenza infections over a 3 year period in transplant patients using a registry system. The investigators plan to generate robust data on clinical features of upper and lower respiratory disease, antiviral therapy and its effects on disease outcome, as well as quantitative virologic data on shedding and antiviral resistance. The investigators also will study the long term sequelae of influenza infections and look at development of rejection.
The purpose of this study is to determine whether nonpharmaceutical interventions (i.e., handwashing and masks) reduce secondary transmission of influenza in households.
This study has been designed to determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention / working memory / processing speed / mood as compared to subjects receiving standard of care alone. The cognitive tests employed are objective measures developed and administered online by HeadMinder Inc.
Current guidelines recommend early initiation of empiric antibiotic therapy to cover typical and atypical bacteria that may cause community-acquired pneumonia (CAP). Influenza antiviral therapy in patients with suspected or confirmed influenza. However, many clinicians do not suspect influenza among patients with CAP or other acute lower respiratory tract illness (LRTI) and often do not test for influenza. Additionally, results from currently available diagnostic tests for influenza may be delayed and several tests have low sensitivity and will give false negative results. Thus, anti-influenza treatment for patients with hospitalized influenza CAP and LRTI is frequently initiated late if at all. There is an association between delayed time to administration of empiric antibiotic therapy with increased clinical failure and mortality. As a result, empiric antibiotic therapy for patients with suspect CAP is begun within 4 - 6 hours of hospitalization. This has recently been demonstrated for delayed antiviral treatment as well. We hypothesize that, as happens with early empiric antibiotics for bacterial CAP, a standardized approach of adding early empiric anti-influenza therapy during the influenza season to hospitalized patients with suspect CAP and LRTI will improve clinical outcomes of patients with influenza associated CAP and LRTI. To test our hypothesis we plan a prospective, randomized, multicenter clinical trial of hospitalized patients with acute LRTI, including suspect CAP, during . If early anti-influenza medications were not included on the patients admission orders, patients will be randomized to standard care, including empiric antibacterial therapy as recommended by ATS/IDSA guidelines plus standard influenza diagnostics and treatment (Standard of care) versus early initiation of empiric antiinfluenza therapy plus standard care, e.g. empiric antibacterial (oseltamivir group). The primary study outcome will be development of clinical failure and selected clinical outcomes during the 30 days after enrollment. Other clinical outcomes that will be compared between study groups include time to clinical stability, duration of hospitalization, development of cardiovascular events, re-hospitalization, short-term mortality (30 days), and long-term mortality (1 year). The secondary study outcome will be the cost-effectiveness of the intervention.