PPE and Air Hygiene for Flu Prevention
(EMIT-2 Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Maryland, Baltimore
Must not be taking: Asthma medications, Immunosuppressants
Disqualifiers: Respiratory, Cardiovascular, Neurological, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of aerosols for influenza may be identified.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications. However, if you are on medications that suppress the immune system or treat significant medical conditions like respiratory or cardiovascular diseases, you may not be eligible to participate.
What data supports the effectiveness of the treatment PPE and Air Hygiene for Flu Prevention?
Personal protective equipment (PPE) is known to be crucial in preventing the spread of influenza and other contagious respiratory illnesses, as highlighted by its importance during the COVID-19 pandemic.
12345Is PPE generally safe for humans?
The research articles provided do not contain specific safety data about PPE (Personal Protective Equipment) like face masks, gloves, or gowns for flu prevention, but they emphasize the importance of understanding and preventing adverse events in healthcare settings.
678910How does the PPE and Air Hygiene treatment for flu prevention differ from other treatments?
This treatment focuses on using personal protective equipment (PPE) and air hygiene measures to prevent flu, which is different from traditional methods like vaccination or antiviral drugs. It emphasizes non-drug interventions, such as masks and improved air quality, to reduce virus transmission.
13111213Eligibility Criteria
This trial is for healthy adults aged 18-49 who have recently contracted the flu. Participants must understand the study, stay in a research unit for about 5 days, and attend follow-ups. Pregnant or breastfeeding women, smokers, those with severe allergies to medicines, immunosuppressed individuals or those on certain medications cannot join.Inclusion Criteria
I've had a fever over 100.2°F and a cough or sore throat in the last 3 days without another known cause.
I am between 18 and 49 years old, not pregnant, and not breastfeeding.
I agree to the study's terms and can stay in quarantine for about 5 days.
+5 more
Exclusion Criteria
I am immunosuppressed or take medication that affects my immune system.
Known allergy or intolerance to treatments for influenza and other respiratory infections.
Any condition, to include medical and psychiatric conditions, that in the opinion of the Investigator, might interfere with the safety of the subject or the study objectives.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are exposed to controlled human influenza virus infection and interventions to reduce airborne transmission are implemented
2 weeks
Follow-up
Participants are monitored for serological, symptomatic, and viral confirmation of influenza infection
2 weeks
Participant Groups
The EMIT-2 trial is testing how well Personal Protective Equipment (PPE) works under different air hygiene conditions to prevent airborne transmission of influenza. People will be randomly assigned to either use PPE or not under low and high air cleanliness settings.
3Treatment groups
Experimental Treatment
Active Control
Group I: Intervention RecipientsExperimental Treatment2 Interventions
Intervention recipients are participants who do not have influenza and will use personal protective equipment.
Group II: DonorsExperimental Treatment2 Interventions
Donors are persons naturally infected with influenza.
Group III: Control RecipientsActive Control1 Intervention
Control recipients are participants who do not have influenza and will not be using personal protective equipment.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Maryland, College Park School of Public HealthCollege Park, MD
University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global HealthBaltimore, MD
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Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
University of Maryland, College ParkCollaborator
References
Stockpile of personal protective equipment in hospital settings: preparedness for influenza pandemics. [2021]Personal protective equipment (PPE) is known to be a crucial means of preventing influenza pandemics; however, the amount of PPE that should be stored in hospital settings has been unclear.
How clinicians manage routinely low supplies of personal protective equipment. [2022]Recommended personal protective equipment (PPE) is routinely limited or unavailable in low-income countries, but there is limited research as to how clinicians adapt to that scarcity, despite the implications for patients and workers.
Investigation of the selection and use of "other" personal protective equipment to prevent mucous membrane exposure in nurses: A cross-sectional study. [2023]Selection and use of personal protective equipment (PPE) to prevent non-percutaneous body fluid exposure (NP BFE) is determined by a clinical assessment of risk. The aim of this study was to explore the selection and use of PPE, particularly masks and eye protection to prevent NP BFE, by nurses.
The Effect of Different Personal Protective Equipment Masks on Health Care Workers' Cardiopulmonary Resuscitation Performance During the Covid-19 Pandemic. [2021]Personal protective equipment (PPE) is equipment that protects health care workers from harmful agents and organisms. The importance of this equipment was noticed again with the Coronavirus Disease 2019 (COVID-19) pandemic.
Personal protection equipment for biological hazards: does it affect tracheal intubation performance? [2020]Personal protection equipment (PPE) is recommended for use during airway management of patients with highly contagious respiratory tract illness. While its use in chemical hazards and its effect on airway management has been assessed previously, there has been no research assessing whether this equipment affects the ability to perform tracheal intubation. It is the intention of this investigation to answer this question.
[Clinical safety paediatric patients]. [2012]To describe the incidence and types of adverse events in children and how they can be prevented.
Top 10 technology hazards for 2011. A guide for prioritizing your patient safety initiatives. [2011]Most adverse incidents involving health technology are preventable. But they need to be clearly understood and thoughtfully acted upon. Here are 10 sources of potential danger that warrant particular attention in 2011, along with recommendations for protecting patients and staff.
Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. [2023]Clear definition, identification, and reporting of adverse event (AE) monitoring during training interventions are essential for decision making regarding the safety of training and testing in youths.
Effect of Surgical Safety checklist implementation on the occurrence of postoperative complications in orthopedic patients. [2014]Surgical adverse events are errors that emerge during perioperative patient care. The World Health Organization recently published "Guidelines for Safe Surgery."
Adverse events among children in Canadian hospitals: the Canadian Paediatric Adverse Events Study. [2022]Limited data are available on adverse events among children admitted to hospital. The Canadian Paediatric Adverse Events Study was done to describe the epidemiology of adverse events among children in hospital in Canada.
The use of personal protective equipment for control of influenza among critical care clinicians: A survey study. [2009]Intensive care units (ICUs) are potential high-risk areas for transmission of viruses causing febrile respiratory illness, such as influenza. Healthcare-associated influenza is prevented through healthcare worker (HCW) vaccination and effective use of U.S. Centers for Disease Control and Prevention recommended infection control practices, including use of personal protective equipment (PPE). Although effective PPE use may significantly reduce healthcare-associated influenza transmission, PPE adherence among ICU HCWs for preventing nosocomial influenza infection has not been evaluated.
Reduction of seasonal influenza transmission among healthcare workers in an intensive care unit: a 4-year intervention study in Thailand. [2015]To evaluate the feasibility and effectiveness of an influenza control bundle to minimize healthcare-associated seasonal influenza transmission among healthcare workers (HCWs) in an intensive care unit (ICU) equipped with central air conditioning.
Nonpharmaceutical Measures for Pandemic Influenza in Nonhealthcare Settings-Personal Protective and Environmental Measures. [2021]There were 3 influenza pandemics in the 20th century, and there has been 1 so far in the 21st century. Local, national, and international health authorities regularly update their plans for mitigating the next influenza pandemic in light of the latest available evidence on the effectiveness of various control measures in reducing transmission. Here, we review the evidence base on the effectiveness of nonpharmaceutical personal protective measures and environmental hygiene measures in nonhealthcare settings and discuss their potential inclusion in pandemic plans. Although mechanistic studies support the potential effect of hand hygiene or face masks, evidence from 14 randomized controlled trials of these measures did not support a substantial effect on transmission of laboratory-confirmed influenza. We similarly found limited evidence on the effectiveness of improved hygiene and environmental cleaning. We identified several major knowledge gaps requiring further research, most fundamentally an improved characterization of the modes of person-to-person transmission.