Environmental Monitoring of Legionella in Hospitals in the Campania Region: A 5-Year Study.

Legionella is a pathogen that colonizes soils, freshwater, and building water systems. People who are most affected are those with immunodeficiencies, so it is necessary to monitor its presence in hospitals. The purpose of this study was to evaluate the presence of Legionella in water samples collected from hospitals in the Campania region, Southern Italy. A total of 3365 water samples were collected from January 2018 to December 2022 twice a year in hospital wards from taps and showers, tank bottoms, and air-treatment units. Microbiological analysis was conducted in accordance with the UNI EN ISO 11731:2017, and the correlations between the presence of Legionella and water temperature and residual chlorine were investigated. In total, 708 samples (21.0%) tested positive. The most represented species was L. pneumophila 2-14 (70.9%). The serogroups isolated were 1 (27.7%), 6 (24.5%), 8 (23.3%), 3 (18.9%), 5 (3.1%), and 10 (1.1%). Non-pneumophila Legionella spp. represented 1.4% of the total. Regarding temperature, the majority of Legionella positive samples were found in the temperature range of 26.0-40.9 °C. An influence of residual chlorine on the presence of the bacterium was observed, confirming that chlorine disinfection is effective for controlling contamination. The positivity for serogroups other than serogroup 1 suggested the need to continue environmental monitoring of Legionella and to focus on the clinical diagnosis of other serogroups.

Le SARS-CoV-2 a provoqué une augmentation de la consommation d'antibiotiques, provoquant une pandémie silencieuse à l'intérieur de la pandémie. Une analyse rétrospective des données italiennes au premier semestre 2022 SARS-CoV-2 caused a surge in antibiotic consumption causing a silent pandemic inside the pandemic. A retrospective analysis of Italian data in the first half of 2022

Fond. Le phénomène de la résistance aux antibiotiques ne semble pas vouloir s'arrêter, malgré les politiques mondiales de lutte mises en place depuis plusieurs années. Le risque de formes de micro-organismes pathogènes de plus en plus résistants aux antibiotiques courants a conduit les autorités sanitaires du monde entier à porter une plus grande attention au phénomène. La situation préoccupante a conduit à de nouvelles recommandations de l'Organisation mondiale de la santé (OMS) et à des recommandations nationales en Italie à travers le nouveau Plan national de lutte contre la résistance aux antibiotiques 2022-2025 (PNCAR 2022-2025). Avoir pour but. Ce manuscrit vise à sensibiliser tous les professionnels de santé à suivre ce qui est suggéré par les agences réglementaires et les sociétés savantes. Méthode. Nous avons mené une étude rétrospective de la pharmacoutilisation des antibiotiques en Italie, dans la région de Campanie à l'Azienda Sanitaria Locale (ASL) Napoli 3 Sud, sur la consommation au premier semestre 2022 dans une population de plus de 1 million de personnes. Résultat. Les résultats indiquent que la consommation, basée sur des doses journalières définies (DDD), est supérieure à la moyenne nationale. La pandémie de COVID-19 a probablement influencé cette croissance des prescriptions. Conclusions. Notre étude suggère une utilisation informée et appropriée des antibiotiques, afin de s'engager sur une voie vertueuse dans la lutte contre la résistance aux antibiotiques.

What Do We Know About the Smallpox Virus? A Journey Between Clinic and Therapy.

PURPOSE: Modern research is increasingly focusing on the study of new viruses and the re-emergence of past microbes, such as Coronaviruses, particularly Sars-Cov2 that was responsible for the very recent pandemic. METHODS AND RESULTS: This infection manifested itself and still continues to manifest as a severe respiratory syndrome. The main discriminator of whether or not one succeeds in overcoming this infection may depend on a great many factors, but the main one is definitely determined by vaccination, which has minimized hospitalizations and more severe syndromes. CONCLUSION: Recently, a new virus, the monkeypox virus, which was previously confined to Central and West Africa but is now gradually spreading to more than 30 countries including the United States of America, where such an infection is not endemic, is coming forward again.

Pandemic COVID-19, an update of current status and new therapeutic strategies.

The global COVID-19 pandemic is underway. In recent weeks, several countries throughout the globe, and particularly in Europe, have experienced an exponential increase in the number of individuals infected with COVID-19, probably induced by a new variant of SARS-CoV-2, called the "Omicron variant." Mass vaccination against COVID-19 continues worldwide. Are authorized mRNA vaccines effective against the new Omicron variant? Recently, several pharmaceutical companies have developed oral antiviral pills against SARS-CoV-2, i.e., molnupiravir and paxlovid, that inhibit SARS-CoV-2 viral replication by acting on the RNA polymerase of SARS-CoV. In pre-registration clinical trials, molnupiravir and paxlovid have shown excellent clinical efficacy results, but what impact will these new oral antiviral agents have against pandemic COVID-19? In what specific clinical situations are they preferred over other antivirals such as remdesivir? In this brief review, we explore these important aspects.

Long COVID could become a widespread post-pandemic disease? A debate on the organs most affected.

Long COVID is an emerging problem in the current health care scenario. It is a syndrome with common symptoms of shortness of breath, fatigue, cognitive dysfunction, and other conditions that have a high impact on daily life. They are fluctuating or relapsing states that occur in patients with a history of SARS-CoV-2 infection for at least 2 months. They are usually conditions that at 3 months after onset cannot be explained by an alternative diagnosis. Currently very little is known about this syndrome. A thorough review of the literature highlights that the cause is attributable to deposits of tau protein. Massive phosphorylation of tau protein in response to SARS-CoV-2 infection occurred in brain samples from autopsies of people previously affected with COVID-19. The neurological disorders resulting from this clinical condition are termed tauopathies and can give different pathological symptoms depending on the involved anatomical region of the brain. Peripheral small-fiber neuropathies are also evident among patients with Long COVID leading to fatigue, which is the main symptom of this syndrome. Certainly more research studies could confirm the association between tau protein and Long COVID by defining the main role of tau protein as a biomarker for the diagnosis of this syndrome that is widespread in the post-pandemic period.

Overview of pharmacotherapy targeting COVID-19 disease based on ACE-2: current challenges and future directions.

The new Severe acute respiratory syndrome coronavirus 2 (SARS-CoV­2) triggered the pandemic of COVID-19, which is currently still ongoing. In 2021 a worldwide vaccine campaign was launched, and in parallel the lines of research are continuing to target the most effective drug therapies for the treatment of COVID-19 disease. SARS-CoV­2 enters host cells via glycoprotein angiotensin-converting enzyme 2 (ACE-2), which plays a major role in renin-angiotensin system interactions and undergoes changes in expression during metabolic and viral diseases, including COVID-19. It seems that the severe lung damage that occurs in several cases of COVID-19 disease may be connected to a deregulated expression of ACE­2. In this manuscript we focus on the line of research that studies the pharmacological modification of ACE­2 expression, a promising weapon to counter the severe harms caused by COVID-19.

COVID-19 mRNA Vaccines: A Retrospective Observational Pharmacovigilance Study.

BACKGROUND AND OBJECTIVE: Coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus has caused millions of deaths worldwide. The mRNA vaccines prevented the figure from being more severe. The objective of this retrospective study is to evaluate the safety of COVID-19 vaccines by analyzing the adverse events following immunization (AEFIs). METHODS: A retrospective observational pharmacovigilance study was conducted, based on the collection of reports of suspected AEFIs reported between 1 January 2021 and 31 December 2021 at the Naples 3 local health authority. AEFIs were stratified and described according to mRNA vaccine, demographics, clinical status, description of AEFI, and degree of severity. In 2021, local health authority Asl Naples 3 South received 1164 reports of suspected adverse events that occurred following the administration of mRNA vaccines. RESULTS: During the reporting period, 746 reports were related to the Comirnaty vaccine (64.1%), 281 to the Vaxzevria vaccine (24.1%), 107 to the Spikevax vaccine (9.2%), and 30 to the Jcovden vaccine (2.6%); 89.3% of the reports were classified as not serious (N = 1039 reports), the remaining 10.7% as serious (N = 125 reports). CONCLUSIONS: This retrospective pharmacovigilance study demonstrates that COVID-19 mRNA vaccines are safe in all population groups.

Pharmacovigilance is an activity that ensures the safety of health care treatments. The COVID-19 pandemic has accelerated the administration of vaccines whose efficacy and safety is to be evaluated. In the year 2021, an analysis of all reported adverse events following immunization (AEFIs) to the vaccine was conducted on a sample of about 1 million people with the aim of understanding efficacy and safety. All adverse events were divided by age, sex, type of reaction, and severity. Serious reactions were divided into subcategories to report the most common critical issues. At the conclusion of the work, it can be seen that COVID-19 mRNA vaccines are safe but can give serious cardiovascular (12% of the total number of serious reports) and neurological (one serious case that led to the development of Guillain Barré syndrome) side effects that need to be monitored by medical personnel.

Nirmatrelvir-remdesivir association for non-hospitalized adults with COVID-19, point of view.

The efforts of the scientific world directed to identifying new antiviral drugs and therapies effective against SARS-CoV-2 continue. New oral antivirals against SARS-CoV-2 such as paxlovid have recently authorized. Evidence shows that these antivirals have good efficacy in reducing the risk of hospitalization in COVID-19 positive patients. Remdesivir is an authorized antiviral for the treatment of SARS-CoV-2 infection. To date, there are still few data in the literature on the safety profile and the risk of generating antiviral-resistant SARS-CoV-2 drug variants. In this manuscript we describe the evidence in the literature on the monotherapy use of paxlovid and monotherapy use of remdesivir, and the scientific hypothesis of using nirmatrelvir and remdesivir in association with the aim of increasing treatment efficacy, reducing the risk of adverse reactions and generating antiviral drug-resistant variants.

Risk of SARS-CoV-2 Infection Breakthrough among the Non-Vaccinated and Vaccinated Population in Italy: A Real-World Evidence Study Based on Big Data.

SARS-CoV-2 infection after vaccination can occur because COVID-19 vaccines do not offer 100% protection. The study aim was to assess duration of vaccination coverage, disease symptoms and type of hospitalization among non-vaccinated and vaccinated subjects to evaluate the vaccination trend over time. A retrospective cohort study was carried out among people testing COVID-19 positive in Campania Region using information from the Health Information System of Campania Region (Sinfonia). Vaccination status was assessed considering: no vaccination, partial vaccination and effective vaccination. Univariate and multivariate logistic regression models were constructed to evaluate the association between ICU admissions caused by COVID-19 and gender, age groups and vaccine type. Vaccine coverage duration trends were investigated using segmented linear regression and breakpoint estimations. Vaccination coverage was assessed by analyzing COVID-19 positive subjects in the 9 months after an effective dose vaccination. A significant risk of hospitalization in the ICU was caused by vaccination status: subjects non-vaccinated (OR: 7.14) and partially vaccinated (OR: 3.68) were 3 and 7 times more at risk of hospitalization, respectively, than subjects effectively vaccinated. Regarding subjects with an effective vaccination, the vaccine's ability to protect against infection in the months following vaccination decreased. The risk of contracting COVID-19 after vaccination was higher 5 months (ß = 1441, p < 0.001) and 7 months (ß = 3110, p < 0.001) after administration of an effective dose. COVID-19 vaccines were demonstrated to protect from symptomatic infection by significantly reducing hospitalization risk, and their full protection against SARS-CoV-2 was demonstrated to decrease after 5 months regardless of age, gender or vaccine type.

Postvaccination SARS-CoV-2 Infections among Healthcare Professionals: A Real World Evidence Study.

Due to the COVID-19 pandemic, all countries with a global mobilization started to produce and authorize vaccines, prioritizing healthcare professionals (HCPs) to reduce transmission. The aim of this study was to assess post-vaccination infections' occurrence among HCPs and their correlation with symptom onset. A retrospective cohort study was carried out in the Campania Region from December 2020 to April 2021. Data were retrieved from the Regional Health Information System of the Campania Region (Sinfonia). The study cohort included subjects that had all received at least one vaccine dose. Risk ratios (RRs) adjusted for age and sex (95% confidence intervals) were performed to assess differences in the prevalence between HCPs who tested positive or negative for COVID-19. Univariate and multivariate logistic regression models were used to evaluate the association between symptoms and vaccination status. Findings revealed that HCPs had a lower risk of contracting COVID-19 after receiving at least one vaccine dose, and this risk decreased with age. Furthermore, not having full vaccination coverage may predict a severe/critical evolution of the disease. This study provides a snapshot of the initial state of the Italian vaccination campaign on HCPs. A surveillance approach using Big Data matched to clinical conditions could offer a real analysis in the categorization of subjects most at risk.

Pregnancy and COVID-19, focus on vaccine and pharmacological treatment.

The global pandemic of COVID-19 is currently ongoing. Clinical evidence shows that specific population groups such as the elderly, individuals with comorbidities, and pregnant women may be at increased risk for infection and serious complications. In particular, physiologic changes during pregnancy may be significant on the immune and respiratory systems and progression of COVID-19 disease. Pregnant women are routinely excluded from pre-registration clinical trials, this potentially limits their access to therapies through off-label or compassionate use. Vaccination remains an important pillar of the response to COVID-19, particularly as variants of the virus continue to spread across countries. Growing evidence indicates that COVID-19 mRNA vaccines do not cause pregnancy complications for expectant mothers and their infants. In this brief review, we explore current knowledge about COVID-19 in pregnancy by highlighting current recommendations for vaccination and drug treatments.

Postvaccination SARS-CoV-2 Infections among Healthcare Professionals: A Real World Evidence Study

Due to the COVID-19 pandemic, all countries with a global mobilization started to produce and authorize vaccines, prioritizing healthcare professionals (HCPs) to reduce transmission. The aim of this study was to assess post-vaccination infections' occurrence among HCPs and their correlation with symptom onset. A retrospective cohort study was carried out in the Campania Region from December 2020 to April 2021. Data were retrieved from the Regional Health Information System of the Campania Region (Sinfonia). The study cohort included subjects that had all received at least one vaccine dose. Risk ratios (RRs) adjusted for age and sex (95% confidence intervals) were performed to assess differences in the prevalence between HCPs who tested positive or negative for COVID-19. Univariate and multivariate logistic regression models were used to evaluate the association between symptoms and vaccination status. Findings revealed that HCPs had a lower risk of contracting COVID-19 after receiving at least one vaccine dose, and this risk decreased with age. Furthermore, not having full vaccination coverage may predict a severe/critical evolution of the disease. This study provides a snapshot of the initial state of the Italian vaccination campaign on HCPs. A surveillance approach using Big Data matched to clinical conditions could offer a real analysis in the categorization of subjects most at risk.

[A retrospective pharmacovigilance analysis: could decreased reporting of suspected adverse reactions generate future safety concerns?] / Un'analisi retrospettiva di farmacovigilanza: la diminuzione della segnalazione di sospette reazioni avverse potrebbe generare futuri problemi di sicurezza?

BACKGROUND: The collection and management of spontaneous reports of suspected adverse drug reactions represents a passive pharmacovigilance method for post-marketing drug safety surveillance, as it is a practical and rapid way to detect a potential warning sign. We performed an in-depth retrospective analysis of suspected adverse reaction reports in the National Pharmacovigilance Network (RNF) for the first eight months of 2019 (pre-pandemic period), 2020 (global pandemic covid-19 onset), 2021 (first post-pandemic period due to vaccine phase). METHODS: The reports of suspected adverse drug reactions were extrapolated from the National Network of Pharmacovigilance. Data from Italy, the Campania Region, and the Local Health Unit Naples 3 South were compared. A retrospective qualitative analysis of demographics data, clinical status, suspected drugs, adverse drug reactions (ADRs) description and its degree of seriousness were collected. RESULTS: We observed 1071 ADRs, of which 281 were serious; of these, 39 led to hospitalization, 779 were not serious, and 2 caused death. In the pre-pandemic period, chemotherapy drugs most frequently induced ADRs. The year 2020, in the midst of the covid-19 pandemic, saw a clear reduction in the number of drug reports, compared to 2019 and 2021, both at national and regional level, and at ASL Napoli 3 Sud. A reduction in 2020 that ranges from -40.75% to -72.56% at the national and regional level, respectively; reaching as much as -88.13% at the local level in the health authority under analysis. In 2021, on the other hand, there is a clear increase in the number of reports, which numerically exceed even those in 2019 by +194.71% in Italy, +15.25% in the Campania Region, and +90.68% in the Local Health Unit Naples 3 South. CONCLUSIONS: The covid-19 pandemic has affected the trend in the number of reports of suspected adverse drug reactions. This is for several reasons: first, frontline exposed health care workers have been able to devote less time to pharmacovigilance activities to cope with the health emergency, second, since the start of the covid-19 vaccination campaign, health care workers have been more focused on reporting suspected adverse reactions to vaccines. Clinicians should beware of these adverse effects and monitor early warning signs carefully.

Baseline Drug Treatments as Indicators of Increased Risk of COVID-19 Mortality in Spain and Italy.

This study aims to identify baseline medications that, as a proxy for the diseases they are dispensed for, are associated with increased risk of mortality in COVID-19 patients from two regions in Spain and Italy using real-world data. We conducted a cross-country, retrospective, observational study including 8570 individuals from both regions with confirmed SARS-CoV-2 infection between 4 March and 17 April 2020, and followed them for a minimum of 30 days to allow sufficient time for the studied event, in this case death, to occur. Baseline demographic variables and all drugs dispensed in community pharmacies three months prior to infection were extracted from the PRECOVID Study cohort (Aragon, Spain) and the Campania Region Database (Campania, Italy) and analyzed using logistic regression models. Results show that the presence at baseline of potassium-sparing agents, antipsychotics, vasodilators, high-ceiling diuretics, antithrombotic agents, vitamin B12, folic acid, and antiepileptics were systematically associated with mortality in COVID-19 patients from both countries. Treatments for chronic cardiovascular and metabolic diseases, systemic inflammation, and processes with increased risk of thrombosis as proxies for the conditions they are intended for can serve as timely indicators of an increased likelihood of mortality after the infection, and the assessment of pharmacological profiles can be an additional approach to the identification of at-risk individuals in clinical practice.

Pre-Exposure Prophylaxis with Hydroxychloroquine Does Not Prevent COVID-19 nor Virus Related Venous Thromboembolism.

Different and several public health strategies have been planned to reduce transmission of pandemic due to SARS-CoV-2 since it started. None drugs have been confirmed as able to prevent viral transmission. Hydroxychloroquine with its immunomodulatory properties has been proposed as potential anti-viral drug in particular for prevention once viral exposure has been happen or in first phases of infection. Furthermore, in several immunological systemic disease hydroxychloroquine was able to reduce the number of thrombotic complications. So, because COVID-19 was associated to immunological imbalance and to thrombotic complications, we retrospectively analyzed the rate of infection in those patients being under treatment with this drug during COVID-19 epidemic outbreak from 8 March until 28 April in particular comparing those with pre-exposure to this treatment and those that were not taking this medication before SARS-CoV-2 viral infections.

Diagnostic issues faced by a rare disease healthcare network during Covid-19 outbreak: data from the Campania Rare Disease Registry.

BACKGROUND: The aims of this study were: to investigate the capacity of the rare disease healthcare network in Campania to diagnose patients with rare diseases during the outbreak of Covid-19; and to shed light on problematic diagnoses during this period. METHODS: To describe the impact of the Covid-19 pandemic on the diagnosis of patients with rare diseases, a retrospective analysis of the Campania Region Rare Disease Registry was performed. A tailored questionnaire was sent to rare disease experts to investigate major issues during the emergency period. RESULTS: Prevalence of new diagnoses of rare disease in March and April 2020 was significantly lower than in 2019 (117 versus 317, P < 0.001 and 37 versus 349, P < 0.001, respectively) and 2018 (117 versus 389, P < 0.001 and 37 versus 282, P < 0.001, respectively). Eighty-two among 98 rare disease experts completed the questionnaire. Diagnostic success (95%), access to diagnosis (80%) and follow-up (72%), lack of Personal Protective Equipment (60%), lack of Covid-19 guidelines (50%) and the need for home therapy (78%) were the most important issues raised during Covid-19 outbreak. CONCLUSIONS: This study describes the effects of the Covid-19 outbreak on the diagnosis of rare disease in a single Italian region and investigates potential issues of diagnosis and management during this period.

Therapeutic strategies to fight COVID-19: Which is the status artis?

COVID-19 is a complex disease, and many difficulties are faced today especially in the proper choice of pharmacological treatments. The role of antiviral agents for COVID-19 is still being investigated and evidence for immunomodulatory and anti-inflammatory drugs is quite conflicting, whereas the use of corticosteroids is supported by robust evidence. The use of heparins in hospitalized critically ill patients is preferred over other anticoagulants. There are conflicting data on the use of convalescent plasma and vitamin D. According to the World Health Organization (WHO), many vaccines are in Phase III clinical trials, and some of them have already received marketing approval in European countries and in the United States. In conclusion, drug repurposing has represented the main approach recently used in the treatment of patients with COVID-19. At this moment, analysis of efficacy and safety data of drugs and vaccines used in real-life context is strongly needed. LINKED ARTICLES: This article is part of a themed issue on The second wave: are we any closer to efficacious pharmacotherapy for COVID 19? (BJP 75th Anniversary). To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v179.10/issuetoc.

Drug-utilisation profiles and COVID-19.

Coronavirus disease 2019 (COVID-19) has substantially challenged healthcare systems worldwide. By investigating population characteristics and prescribing profiles, it is possible to generate hypotheses about the associations between specific drug-utilisation profiles and susceptibility to COVID-19 infection. A retrospective drug-utilisation study was carried out using routinely collected information from a healthcare database in Campania (Southern Italy). We aimed to discover the prevalence of drug utilisation (monotherapy and polytherapy) in COVID-19 versus non-COVID-19 patients in Campania (~ 6 million inhabitants). The study cohort comprised 1532 individuals who tested positive for COVID-19. Drugs were grouped according to the Anatomical Therapeutic Chemical (ATC) classification system. We noted higher prevalence rates of the use of drugs in the ATC categories C01, B01 and M04, which was probably linked to related comorbidities (i.e., cardiovascular and metabolic). Nevertheless, the prevalence of the use of drugs acting on the renin-angiotensin system, such as antihypertensive drugs, was not higher in COVID-19 patients than in non-COVID-19 patients after adjustments for age and sex. These results highlight the need for further case-control studies to define the effects of medications and comorbidities on susceptibility to and associated mortality from COVID-19.