Requirements and study designs for US regulatory approval of influenza home tests

2021 ◽  
Author(s):  
Tony Yang ◽  
Larry G. Kessler ◽  
Matthew J. Thompson ◽  
Barry R. Lutz
Keyword(s):  
Infectious Disease ◽  
Market Access ◽  
Respiratory Infections ◽  
Regulatory Pathways ◽  
Home Based ◽  
Home Testing ◽  
Home Tests ◽  
Us Fda ◽  
Viral Respiratory Infections ◽  
Study Designs

Home testing for infectious disease has come to the forefront during the COVID-19 pandemic. There is now considerable commercial interest in developing complete home tests for a variety of viral and bacterial pathogens. However, the regulatory science around home infectious disease test approval, and procedures test manufacturers and laboratory professionals will need to follow, have not yet been formalized by US FDA, with the exception of EUA guidance for COVID-19 tests. We describe the state of home-based testing for influenza with a focus on sample-to-result home tests, discuss the various regulatory pathways by which these products can reach populations, and provide recommendations for study designs, patient samples, and other important features necessary to gain market access. These recommendations have potential application for home use tests being developed for other viral respiratory infections, such as COVID-19, as guidance moves from EUA designation into 510(k) requirements.

scholarly journals The lung–gut axis during viral respiratory infections: the impact of gut dysbiosis on secondary disease outcomes

2021 ◽  
Author(s):  
Valentin Sencio ◽  
Marina Gomes Machado ◽  
François Trottein
Keyword(s):  
Gut Microbiota ◽  
Bacterial Infections ◽  
Respiratory Infections ◽  
Critical Role ◽  
Good Health ◽  
Disease Outcomes ◽  
And Function ◽  
Viral Respiratory Infections ◽  
The Impact ◽  
Viral Respiratory

AbstractBacteria that colonize the human gastrointestinal tract are essential for good health. The gut microbiota has a critical role in pulmonary immunity and host’s defense against viral respiratory infections. The gut microbiota’s composition and function can be profoundly affected in many disease settings, including acute infections, and these changes can aggravate the severity of the disease. Here, we discuss mechanisms by which the gut microbiota arms the lung to control viral respiratory infections. We summarize the impact of viral respiratory infections on the gut microbiota and discuss the potential mechanisms leading to alterations of gut microbiota’s composition and functions. We also discuss the effects of gut microbial imbalance on disease outcomes, including gastrointestinal disorders and secondary bacterial infections. Lastly, we discuss the potential role of the lung–gut axis in coronavirus disease 2019.

scholarly journals 143. Initial Impact of COVID-19 on Ambulatory Antibiotic Prescribing for Respiratory Viral Infections

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S82-S82
Author(s):  
Zahra Kassamali Escobar ◽  
Todd Bouchard ◽  
Jose Mari Lansang ◽  
Scott Thomassen ◽  
Joanne Huang ◽  
...  
Keyword(s):  
Primary Care ◽  
Viral Infections ◽  
Respiratory Infections ◽  
Urgent Care ◽  
Antibiotic Prescribing ◽  
Specific Rate ◽  
Inclusion Criteria ◽  
Diagnosis Codes ◽  
Control And Prevention ◽  
Viral Respiratory Infections

Abstract Background Between 15–50% of patients seen in ambulatory settings are prescribed an antibiotic. At least one third of this usage is considered unnecessary. In 2019, our institution implemented the MITIGATE Toolkit, endorsed by the Centers for Disease Control and Prevention to reduce inappropriate antibiotic prescribing for viral respiratory infections in emergency and urgent care settings. In February 2020 we identified our first hospitalized patient with SARS-CoV(2). In March, efforts to limit person-to-person contact led to shelter in place orders and substantial reorganization of our healthcare system. During this time we continued to track rates of unnecessary antibiotic prescribing. Methods This was a single center observational study. Electronic medical record data were accessed to determine antibiotic prescribing and diagnosis codes. We provided monthly individual feedback to urgent care prescribers, (Sep 2019-Mar 2020), primary care, and ED providers (Jan 2020 – Mar 2020) notifying them of their specific rate of unnecessary antibiotic prescribing and labeling them as a top performer or not a top performer compared to their peers. The primary outcome was rate of inappropriate antibiotic prescribing. Results Pre toolkit intervention, 14,398 patient visits met MITIGATE inclusion criteria and 12% received an antibiotic unnecessarily in Jan-April 2019. Post-toolkit intervention, 12,328 patient visits met inclusion criteria and 7% received an antibiotic unnecessarily in Jan-April 2020. In April 2020, patient visits dropped to 10–50% of what they were in March 2020 and April 2019. During this time the unnecessary antibiotic prescribing rate doubled in urgent care to 7.8% from 3.6% the previous month and stayed stable in primary care and the ED at 3.2% and 11.8% respectively in April compared to 4.6% and 10.4% in the previous month. Conclusion Rates of inappropriate antibiotic prescribing were reduced nearly in half from 2019 to 2020 across 3 ambulatory care settings. The increase in prescribing in April seen in urgent care and after providers stopped receiving their monthly feedback is concerning. Many factors may have contributed to this increase, but it raises concerns for increased inappropriate antibacterial usage as a side effect of the SARS-CoV(2) pandemic. Disclosures All Authors: No reported disclosures

scholarly journals Multidrug Resistence Prevalence in COVID Area

Life ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 601
Author(s):  
Caterina Aurilio ◽  
Pasquale Sansone ◽  
Antonella Paladini ◽  
Manlio Barbarisi ◽  
Francesco Coppolino ◽  
...  
Keyword(s):  
Bacterial Resistance ◽  
Respiratory Infections ◽  
Prolonged Mechanical Ventilation ◽  
Viral Disease ◽  
Multidrug Resistant ◽  
Resistant Bacteria ◽  
Antimicrobial Drugs ◽  
Infected People ◽  
Therapeutic Procedures ◽  
Viral Respiratory Infections

Coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, is often complicated by severe acute respiratory syndrome. The new coronavirus outbreak started in China in December 2019 and rapidly spread around the world. The high diffusibility of the virus was the reason for the outbreak of the pandemic viral disease, reaching more than 100 million infected people globally by the first three months of 2021. In the various treatments used up to now, the use of antimicrobial drugs for the management, especially of bacterial co-infections, is very frequent in patients admitted to intensive care. In addition, critically ill patients with SARS-CoV-2 infection are subjected to prolonged mechanical ventilation and other therapeutic procedures often responsible for developing hospital co-infections due to multidrug-resistant bacteria. Co-infections contribute to the increase in the morbidity–mortality of viral respiratory infections. We performed this study to review the recent articles published on the antibiotic bacterial resistance and viruses to predict risk factors of coronavirus disease 2019 and to assess the multidrug resistance in patients hospitalized in the COVID-19 area.

scholarly journals COVID-19 mitigation strategies were associated with decreases in other respiratory virus infections

2021 ◽  
Author(s):  
Sinha Pranay ◽  
Katherine Reifler ◽  
Michael Rossi ◽  
Manish Sagar
Keyword(s):  
Respiratory Virus ◽  
Respiratory Infections ◽  
Respiratory Viruses ◽  
Mitigation Strategies ◽  
Virus Infections ◽  
Time Period ◽  
Viral Respiratory Infections ◽  
Respiratory Virus Infections ◽  
Viral Respiratory

Abstract Detection of diverse respiratory viruses in Boston was around 80% lower after practices were instituted to limit COVID-19 spread compared to the same time period during the previous five years. Continuing the strategies that lower COVID-19 dissemination may be useful in decreasing the incidence of other viral respiratory infections.

scholarly journals Spatial and Temporal Spread of Acute Viral Respiratory Infections in Young Children Living in High-altitude Rural Communities

2016 ◽  
Vol 35 (10) ◽  
pp. 1057-1061 ◽  
Author(s):  
Charlotte Buehler Cherry ◽  
Marie R. Griffin ◽  
Kathryn M. Edwards ◽  
John V. Williams ◽  
Ana I. Gil ◽  
...  
Keyword(s):  
Rural Communities ◽  
Young Children ◽  
High Altitude ◽  
Respiratory Infections ◽  
Viral Respiratory Infections ◽  
Viral Respiratory ◽  
Temporal Spread

scholarly journals Neutrophils in respiratory viral infections

2021 ◽  
Author(s):  
Cecilia Johansson ◽  
Freja C. M. Kirsebom
Keyword(s):  
Viral Infections ◽  
Immune Cell ◽  
Respiratory Infections ◽  
Fungal Infections ◽  
Severe Disease ◽  
The Elderly ◽  
Viral Control ◽  
Immunological Mechanisms ◽  
Respiratory Viral Infections ◽  
Viral Respiratory Infections

AbstractViral respiratory infections are a common cause of severe disease, especially in infants, people who are immunocompromised, and in the elderly. Neutrophils, an important innate immune cell, infiltrate the lungs rapidly after an inflammatory insult. The most well-characterized effector mechanisms by which neutrophils contribute to host defense are largely extracellular and the involvement of neutrophils in protection from numerous bacterial and fungal infections is well established. However, the role of neutrophils in responses to viruses, which replicate intracellularly, has been less studied. It remains unclear whether and, by which underlying immunological mechanisms, neutrophils contribute to viral control or confer protection against an intracellular pathogen. Furthermore, neutrophils need to be tightly regulated to avoid bystander damage to host tissues. This is especially relevant in the lung where damage to delicate alveolar structures can compromise gas exchange with life-threatening consequences. It is inherently less clear how neutrophils can contribute to host immunity to viruses without causing immunopathology and/or exacerbating disease severity. In this review, we summarize and discuss the current understanding of how neutrophils in the lung direct immune responses to viruses, control viral replication and spread, and cause pathology during respiratory viral infections.

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