Fluid Restriction Keeps Children Dry
Respiratory InfectionFluid Overload2 moreRationale: Fluid overload is a common complication in children who are admitted to the pediatric intensive care for mechanical ventilation. Acute lung infection is a frequent cause for admission to the PICU and forms an uniform group with a single organ failure. In these critically ill children, fluid overload is associated with adverse outcome. Restricting the volume of fluids already in an early stage of ICU admission may prevent fluid overload during mechanical ventilation and thus improve clinical outcome. However, at the same time fluid restriction may interfere with appropriate energy and macronutrient intake that is needed for recovery. Objective: The main goal of this pilot study is to evaluate the feasibility of a restrictive fluid management protocol and investigate its effect on the occurrence of fluid overload in mechanically ventilated children with acute infectious lung disease. Study design: Single-center prospective randomized feasibility and pilot study in preparation of a multi-center randomized controlled trial (RCT). Study population: Mechanically ventilated children with (suspicion of) acute infectious lung disease admitted to the pediatric intensive care unit (PICU) of the Emma Children's Hospital, Academic Medical Center, Amsterdam. Intervention: Patients receive either liberal (control group) or a restrictive (experimental group) fluid treatment, while ensuring appropriate caloric intake. Main study parameters/endpoints: Primary outcomes are cumulative fluid balance and body weight during the first week of mechanical ventilation. Secondary outcomes (in preparation of the larger multi-center RCT) include: mortality, duration of mechanical ventilation and oxygenation indices. To determine the feasibility, in- and exclusion rate, adherence to treatment arms, need for fluid bolus, need for diuretics and hemodynamic indices as well as energy and protein intake are studied. Both fluid management protocols reflect a variant of current clinical practice, hence will not provide extra burden or risk to patients included in the study. Patients will be randomized to either of the fluid protocol arms on admission to the PICU (at start of mechanical ventilation). Patients included in the restrictive fluid treatment arm might have direct benefit from the study if indeed fluid overload is less common in this group.
Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Recurrent Respiratory PapillomatosisThis study evaluates the safety and tolerability of the investigational drug EF-022 in the treatment of adult patients with Recurrent Respiratory Papillomatosis (RRP). Patients will be administered EF-022, either intramuscular or subcutaneous, for a period of 6 months. Preliminary effect of the drug on the disease will be evaluated by following the number and severity of the lesions in the respiratory tract and the effect on voice changes.
Prolonged Infusion Cefepime and Nosocomial Infections
Urinary Tract InfectionRespiratory Tract InfectionIt is advocated that prolonged infusion of beta-lactamic antibiotics provides better bactericidal effect. The aim of the present study is to randomize patients a to extended cefepime infusion regimen (lasting four hours) or to a usual infusion regimen (not lasting more than thirty minutes) and evaluate the clinical efficacy of this theoretical pharmacokinetic advantage.
Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients
Virus DiseasesRespiratory Tract Diseases3 moreThe 2009 flu pandemic is a global outbreak of a new strain of influenza A virus subtype H1N1, commonly known as swine flu, that was first identified in April 2009. Large-scale immunization is an essential approach of controlling the pandemic.Vaccines are now becoming available for protection against pandemic influenza A(H1N1) 2009 infection in some countries.In response to the pandemic, novel vaccines against the virus strain A/California/07/2009(H1N1) have been developed and recently were approved for vaccination among specific populations in China. However, the safety and effectiveness of the vaccines is of prime concern to the authorities and the public.This report details the findings of a observational clinical trial of the safety and immunogenicity of a influenza A (H1N1)2009 monovalent vaccine. The virus of Swine Flu H1N1 that outbroke in 2009 is sensitive to neuraminidase inhibitors (Oseltamivir, zanamivir and peramivir) but have drug resistant to adamantanamine derivatives (amantadine and Flumadine), therefore neuraminidase inhibitors are recommended for antiviral therapy against Swine Flu H1N1, effect of which is evidence by the data that such drugs do modify the symptoms and decrease the death rate of H1N1 in America and Mexico. However, clinically, the investigators have encountered that this virus can infect resistant strains of Oseltamivir, which urges for a more effective treatment plan. In view of above situations, seeking for an effective measures against H1N1 flu should be a top priority and will benefit human life and economy globally. This Topic will take the classic strategy of passive immunity to perform basic and clinical researches on applying blood fix to treat critical H1N1 patients and collect blood of healthy persons who are inoculated with specific H1N1 vaccines to cure critical H1N1 patients.
Doctor-Patient Communication in Spanish
Upper Respiratory InfectionHypertension1 moreDoes use of a translator or use of less than perfect Spanish diminish provider-patient communication compared to a native speaker.
Effectiveness of Improving Diagnostic and Communication Skills on Antibiotic Prescribing Appropriateness...
Respiratory Tract InfectionsCoughDespite their marginal benefit, about 60% of uncomplicated acute lower respiratory infections (ALRTI) are currently treated with antibiotics. Several strategies have been developed to reduce inappropriate antibiotic prescribing, with the use of point-of-care C-reactive protein (CRP) testing and the improvement of the communication skills being the most effective interventions, but most of the studies have been carried out outside Mediterranean countries. This study is aimed at evaluating the effect of a disease-focused intervention (CRP) and an illness-focused intervention (improvement of communication skills to optimise doctor-patient consultations and share-decision making with the aid of patient-centred leaflets) on antibiotic prescribing for patients with ALRTIs in Catalan primary care by means of a cluster, randomised, factorial, controlled trial. Primary care centres will be assigned to four trial arms: usual care, use of CRP testing, enhanced communication skills backed up with leaflets, or combined interventions. The main outcome will be antibiotic use within the first 6 weeks and the quality adjusted life years. A pharmacoeconomic analysis of the impact of these interventions will be assessed.
Multicenter Study to Evaluate Efficacy, Tolerability, Safety of Derinat
Respiratory Infections in ChildrenThis multicenter prospective double blinded placebo-controlled randomized study is designed to to evaluate clinical efficacy, tolerability and safety of medical product Derinat®, solution for external and local use 0.25% in acute infections of respiratory system in children
Infant Formula and Toddler Drink Feeding Intervention
Respiratory Infections in ChildrenThe purpose of this randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children fed a new infant formula and toddler drink through 24 months of age.
Safety and Effectiveness of an Immunobiological Drug in CoViD-19
COVID-19 PneumoniaCOVID-19 Respiratory Infection1 moreThe aims of this study is to analyze the efficacy and safety of a passive immunotherapy strategy using hyperimmune equine serum known as Anti-SARS-CoV-2 elaborated by the National Institute for the Production of Biologicals (ANLIS-Malbrán) as an addition to the standard therapeutic approach for hospitalized patients with COVID-19, in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection aged 18 to 80 years.
HC-1119 Adjuvant Treatment for Hospitalized COVID-19 Patients
COVID-19 Respiratory InfectionThe primary purpose of this study is to evaluate the efficacy of HC-1119 as an adjuvant treatment for hospitalized COVID-19 male and female patients.