LIAISON NES Flu A/B & COVID-19 Clinical Agreement
Influenza AInfluenza Type B1 moreThe DiaSorin Molecular LIAISON® NES FLU A/B & COVID-19 real-time RT-PCR assay is intended for use on the DiaSorin LIAISON® NES instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza A, influenza B and SARS-CoV-2 virus from dry nasal swabs (NS) from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors. The LIAISON® NES FLU A/B & COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A, influenza B and SARS-CoV-2 infection in a professional laboratory setting. Negative results do not preclude influenza A, influenza B, or SARS-CoV-2, infection and should not be used as the sole basis for patient management decisions. The assay is not intended to detect the presence of the influenza C virus.
Clinical Evaluation of SARS-COV-2 (COVID-19), Influenza and RSV 8-Well MT-PCR Panel for In Vitro...
Respiratory Viral InfectionThis study is a prospective accuracy observational study to evaluate the performance of the Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medical device panel and generate performance data. The precision of results will be evaluated in concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1 (RP2.1).
Zoonotic Influenza Surveillance in Belgium
InfluenzaHumanThe project aims at implementing a more pro-active surveillance of potential transmission of influenza viruses to humans (zoonotic transmission). Clinical surveillance of influenza in humans and avian species is well organized and has been operating for decades, but currently there is no pro-active systematic surveillance of potential transmission of animal (avian or swine) influenza viruses to humans, only follow-up of people showing clinical symptoms. People working with potentially infected animals have the highest risk. Moreover, they can represent the first steps in a pandemic: if the virus adapts to humans, infected workers could potentially spread the virus to other people. Currently, highly pathogenic clade2.3.4.4b H5 avian influenza viruses are continuously circulating in wild birds in Belgium and the number of introduction in poultry farms has raised, increasing the contact opportunities with high viral concentrations. Several reports of suspected human infection have been made by different countries. In addition, the virus was detected in sick non-human mammals. The large circulation in wild birds thus represents an increase risk of spill-over to mammalian species, including humans, (by contact directly with wild birds, or via outbreaks in poultry). This increased opportunity for accidental spillover to new host species increases the chances for the avian virus to adapt to mammals, including humans. Likewise, there have also been an increased number of human cases of swine influenza reported by several European countries. A pro-active surveillance aiming at also detecting asymptomatic infections would allow an early detection of transmission that could help to prevent a new pandemic. As a piloting approach during this specific project, some dedicated sentinel networks among at-risk workers will be initiated: people in poultry farms involved with the management of outbreaks of highly pathogenic avian influenza; people working at bird (or more generally wild life) rehabilitation centres or poultry farms; veterinarians working in pig farms/slaughterhouses.
Early Oseltamivir Carboxylate Low Plasma Concentration in Patients Admitted to Intensive Care for...
Severe InfluenzaIntroduction Pandemic and seasonal influenza epidemics can be associated with a high degree of morbidity and mortality, especially in patients developing severe influenza pneumonitis with the acute respiratory distress syndrome (ARDS) or the less frequent fulminant myocarditis. Early administration (i.e. in the first 48 hours) of the neuraminidase inhibitor oseltamivir is associated with reduced mortality in patients hospitalized for severe influenza. Early oseltamivir administration, which can only be given orally (or through a nasogastric tube), is thus recommended by the World Health Organization in patients hospitalized for severe influenza, including those requiring intensive care (ICU) admission. However, enteric absorption may be compromised in critically ill patients due to impaired gut function. Hypothesis/Objective The hypothese is that, in patients admitted for severe influenza, early (i.e., measured at the 48th hour of treatment initiation) oseltamivir carboxylate (OC) low plasma concentration would be: 1) associated with a poor prognosis; and 2) detectable by carrying out a paracetamol absorption test (PAT). The main objective of the study is to determine the prognostic impact of early OC low plasma concentration in patients admitted to the intensive care unit (ICU) for severe influenza. Primary outcome measure: Number of live ventilator-free days at 28-day in patients with versus without OC low plasma concentration.
Influenza Vaccine With Topical Imiquimod in Influenza Vaccine Non-responsive Children
InfluenzaAims and hypotheses to be tested: Primary objective - To compare the IIV responses, in terms of seroconversion rates, using ID IIV with topical 5% imiquimod (IIV-Q-ID), ID influenza vaccine alone (IIV-ID), and the second dose of IM influenza vaccine (IIV-IM) among children who are IIV non-responders. Secondary objectives To determine the IIV non-responder rate in healthy Hong Kong children. To investigate the association between HLA molecules and IIV non-responsiveness. Hypotheses The investigators hypothesize that among IIV non-responder children, the seroconversion rate after ID IIV with topical imiquimod will be significantly higher than a second IM IIV dose. The investigators hypothesize that the IIV non-responder rate is approximately 5-10% in the paediatric population. The investigators hypothesize that certain HLA alleles are associated with IIV non-responders.
Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu
PneumoniaViral1 moreThe H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. The acute respiratory distress syndrome is associated with a substantial mortality and morbidity partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these drugs may cause super infection or metabolic disorders. Thus, there is a need for a randomized double blind, placebo controlled trial to define the benefit to risk ratio of corticosteroids in this patient.
Collaborative H1N1 Adjuvant Treatment Pilot Trial
Critically IllH1N1/Influenza InfectionStudy Design: A, multinational, double blind, placebo-controlled pilot RCT involving 80 patients in the general ICUs of 30 centres. Most patients will be recruited from within Canada; however cases will be recruited from international sites. This study will be conducted under the auspices of the Canadian Critical Care Trials Group (CCCTG) and the International Forum for Acute Care Trialists (InFACT).
Safety and Efficacy of DSM 32444 in the Treatment of Acute Upper Respiratory Infection
InfluenzaRespiratory infection is the leading cause of disease burden worldwide, measured by years lost through death or disability. Of all respiratory infections, influenza is one of the most common illnesses the low middle income countries, and in Vietnam. It is directly responsible for 3-5 million cases of severe illnesses, and 600K deaths. According to the latest data published by World Health Organisation ("WHO") , in 2020, Influenza and Pneumonia deaths in Viet Nam reached 27,836 or 4.06% of total deaths. It also ranks 6th in the leading causes of deaths in Vietnam. As with COVID-19, in Vietnam alone, there were in total 11.5 million cases causing nearly 45,000 deaths. Total hospitalized cases due to SARS-CoV-2 were not measurable, but they created unprecedented pressure on the country's health system. The most common treatment for influenza is antivirals and antibiotics. However, these regimes do have a lot of negative consequences on patients' health in the long term. Current concerns about antimicrobial resistance (AMR) have led to an urgent need for a nature-based next generation therapeutic approach that is safe, effective and helps in addressing the issues of AMR. This phase purpose is to evaluate the safety and efficacy of DSM 32444 in the treatment of influenza and acute upper respiratory infections.
Efficacy and Safety of XC8, Film-coated Tablets, 40 mg in Patients With Dry Non-productive Cough...
Common ColdAcute Respiratory Infection2 moreStudy to assess the efficacy and safety of XC8, film-coated tablets, 10 mg in comparison with placebo in patients with dry non-productive cough against acute respiratory infection.
Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute...
InfluenzaHuman2 moreThe study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, syrup, 30 mg/5 ml, in the treatment of influenza or other acute respiratory infections in children from 6 months to 2 years compared with placebo.