Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults...
Virus DiseasesRNA Virus Infections2 moreThis Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The study is being conducted to demonstrate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria. The study will also help to define the optimal dose, establish potential competitive advantages, and support the design of future studies.
Evaluation of Novel Antimicrobial Hand Towels
Diarrheal DiseasesAcute Respiratory Infections2 moreIn March 2012, the investigators initiated a prospective, cluster-randomized, controlled field trial in Kisumu County, located in an area in western Kenya which has the highest under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter referred to as towel) in preventing diarrheal diseases, acute respiratory infections, self-reported fever, and skin infections in children <2 years old.
Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal VLP Quadrivalent Influenza Vaccine...
Virus DiseasesRNA Virus Infections2 moreThis is a multiple sites phase II trial, randomized, observer-blind, dose ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-based Seasonal VLP Quadrivalent Influenza Vaccine administered in elderly subjects (50 years old and more). A total of four hundred fifty (450) subjects will be randomized in six (6) groups of 75 subjects to receive one injection of either a non-adjuvanted low, medium or high dose level of VLP, a low or high dose level of VLP of the quadrivalent VLP influenza vaccine combined with Alhydrogel® as adjuvant or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80)
Effectiveness of the NoseFrida Compared With Bulb Suction at Relieving Objective Signs of Nasal...
Upper Respiratory Tract InfectionsNasal Suction1 moreThe mainstay of treatment in viral upper and lower respiratory tract disease is airway clearance. Viral respiratory tract infections account for a substantial amount of emergency department (ED) visits, financial and stress burden on caregivers. In addition, they also account for a large number of ED return visits. While airway clearance is considered a mainstay of treatment the pragmatic effectiveness of various devices remain unstudied in patients who are discharged from the ED. The objectives of this study are to compare the pragmatic effectiveness of two commonly used suction devices the NoseFrida and bulb suction and to provide a descriptive analysis on 72 hour return to ED rates and readmission rates. Patients will be enrolled October 15, 2018 to October 15, 2019 or until NoseFrida supplies are depleted. Fridababy will supply 500 NoseFrida devices and replacement filters. Patients aged 1 day to 24 months presenting Vanderbilt Childrens ED with symptoms of nasal congestion or bronchiolitis who require suctioning and will be discharged from the ED will be approached for enrollment. Exclusion criteria include no upper airway abnormalities or previously enrolled in study. The study design is a prospective and retrospective observational study. We anticipate about 500 patients to be enrolled in this study. Families will then be approached for consent to participate. Caregiver will fill out a data collection form then be instructed on how to use the NoseFrida. Next, family with trial it on their child while in the ED. Caregivers will then fill out a 7 point Likert survey on both the bulb suction and NoseFrida device. The family will go home with this device and a set of replacement filters and instructed to suction their child as needed. The primary investigator (PI) will then complete a 72 hour chart review to determine the number of return to ED visits and readmission rates. To compare ED returns with retrospective data, KSP will conduct a review of the business objects database using ICD9 codes specific for viral respiratory tract infections over the past 3 years to determine a control return ED visit rate. Data will be compared using a paired T-test. If data is not normally distributed we will use a Wilcoxon signed-rank test. We will also use a multivariable logistic model to examine associations adjusted for age and illness severity.
A Study to Examine the Duration of Effect of PrEP-001 in Healthy Subjects Challenged With HRV-16...
Viral Upper Respiratory Tract InfectionA study to examine the duration of effect of PrEP-001 in healthy subjects challenged with HRV-16
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
Respiratory Tract InfectionRespiratory Syncytial VirusThe purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of clesrovimab in healthy pre-term (born at 29 to 35 weeks gestational age) and full-term (born at >35 weeks gestational age) infants. Participants will be randomized into 1 of 4 dose escalation panels (Panels A to D); an additional panel (Panel E) of full-term infants will receive the same dose as Panel D. Key safety and tolerability variables will be reviewed after each dose panel prior to administering the next-highest dose.
Impact of the Use of CRP on the Prescription of Antibiotics in General Practitioners
Respiratory InfectionRespiratory Infections in ChildrenRespiratory infections, including episodes of coughing with fever, are the main cause of outpatient antibiotic prescription, while a minority of them are linked to bacterial infections requiring antibiotic. These prescriptions are often performed by general practitioners. These unnecessary antibiotic contribute to increased bacterial resistance, side effects and unnecessary costs. Campaigns for the correct prescription of antibiotics have had a real but partial or transient success. C-reactive protein micro-method (POCT-CRP) could help to differentiate between viral and bacterial infections and thus contribute to the proper use of antibiotics. The decrease in prescription of antibiotics is likely to have an even stronger positive impact in countries like France, where prescription is high. The objective of this study is to evaluate the use of POCT-CRP in the general practitioner's office in case of suspected respiratory infection.
The Association of Hand Hygiene Practice on Primary Schoolgirls Absence Due to URIs in Riyadh City,...
Upper Respiratory Tract InfectionsResearch Problem: Upper respiratory infections (URIs) are a common reason for absence from schools as it is estimated that children get six to eight episodes every year. In Jazan (2013-2014), 34% of primary health care centre attendees who were complaining of URIs were under 15 years old and 42% of them were positive when tested for viruses by nasopharyngeal swabs. An intervention for URIs prevention is hand hygiene, as it has been shown to have an impact on reducing the risk of respiratory infections by 50% among children in Karachi, Pakistan by encouraging hand washing with soap. Another randomised controlled trial study conducted in Spain among primary school students showed a statistically significant 38% reduction in the absenteeism rate due to URIs in the intervention group who received education about hand hygiene and used hand sanitisers which were distributed among schools. Also, the Chinese conducted a cluster randomised control trial evaluating the effect of a hand washing programme and revealed a 38% reduction in absence due to URIs among primary schoolchildren. This preventive measure is questionable, as a randomised controlled trial done among primary school students in New Zealand revealed that encouraging the use of hand sanitisers in schools did not have an impact on reducing acute respiratory infections or absenteeism. The questionable effect was also documented in a systematic review and meta-analysis for randomised controlled trials about the effectiveness of hand hygiene in decreasing absences through illness in educational settings. Research Significance: Appropriate hand hygiene is recommended as a non-pharmacological preventive measure against respiratory infections. But this preventive measure is questionable as the results of randomised controlled trials about the effectiveness of different hand hygiene interventions in reducing absence due to upper respiratory tract infection in different educational settings are controversial. Furthermore, previous studies of hand hygiene interventions were low in quality and it is recommended to improve future studies relating to it. Also, there is no research on the effectiveness of these measures in Saudi Arabia. So, this piece will add new knowledge to local and international literature. In addition, this study may help the school health administration to develop a hand hygiene programme. Objectives: To determine if hand hygiene education is associated with school absence rates due to URIs reduction among primary schoolgirls in Riyadh city, 2017-2018 To measure post-intervention total primary schoolgirl's absence rate (both groups) in Riyadh city, 2017-2018. To measure post-intervention primary schoolgirls' absence rate due to upper respiratory infections (both groups) in Riyadh city, 2017-2018. Methodology: Cluster RCT will be conducted among primary schoolgirls attending public schools in Riyadh city in the first education semester. Sampling will be multistage to end up with four schools. 616 schoolgirls who are attending the selected classes will be invited to the study. Two schools will be randomly assigned to the intervention, which includes one-hour hand washing workshop at the beginning of the study, in addition to posters. Parents will self-administer the questionnaire at baseline, in addition to a follow-up phone interview questionnaire.
Cod Liver Oil for Covid-19 Prevention Study
Covid-19Respiratory Tract InfectionsA randomized, parallel-group treatment, quadruple masked, two-arm study to assess the effectiveness of cod liver oil compared to placebo in the prevention of Covid-19 and airway infections in healthy adults. In this study, the investigators will investigate whether daily cod liver oil can prevent Covid-19 infections and reduce the severity of such infections. The investigators will also examine whether cod liver oil prevents other airway infections in healthy adults.
Echinaforce Study to Investigate Explorative Pharmacology and Effectiveness to Prevent From Enveloped...
Respiratory Tract InfectionsCommon ColdIt is a single-center, randomized, open-label, phase IV study for the explorative investigation of the pharmacological mode-of-action of Echinaforce® extract in the form of Echinaforce® Chewable tablets"- Further, it is aimed to evaluate the effectiveness of the study product for the prevention and treatment of respiratory tract infections in generally healthy adults following a real-life setting. The study covers 2x2 + 1 month of prevention in 120 randomized participants following a tight sampling set-up for sensitive detection of viral infections by RT-qPCR analysis of nasal swabs and seroconversion of SARS-CoV2 IgG/IgM in serum samples.