Publications by authors named "Emma Montella"

12 Publications

  • Page 1 of 1

Evaluation of a fully closed real time PCR platform for the detection of SARS-CoV-2 in nasopharyngeal swabs: a pilot study.

J Clin Pathol 2021 Apr 9. Epub 2021 Apr 9.

Translational Medical Sciences, University of Naples Federico II, Naples, Italy.

Aims: To date, reverse transcriptase PCR (RT-PCR) on nasopharyngeal swabs is the 'gold standard' approach for the diagnosis of COVID-19. The need to develop easy to use, rapid, robust and with minimal hands-on time approaches are warranted. In this setting, the Idylla SARS-CoV-2 Test may be a valuable option. The aim of our study is to evaluate the analytical and clinical performance of this assay on previously tested SARS-CoV-2 people by conventional RT-PCR based approach in different settings, including initial diagnosis and clinical follow-up.

Methods: To evaluate the sensitivity and specificity of the Idylla SARS-CoV-2 Test, we retrieved 55 nasopharyngeal swabs, previously analysed by a fully validated assay, from symptomatic patients or from people who have been in close contact with COVID-19 positive cases. Discordant or high discrepant cases were further analysed by a third technique. In addition, a second subset of 14 nasopharyngeal swab samples with uncertain results (cycle threshold between 37 and 40), by using the fully validated assay, from patients with viral infection beyond day 21, were retrieved.

Results: Overall, Idylla showed a sensitivity of 93.9% and a specificity of 100.0%. In addition, in the additional 14 nasopharyngeal swab samples, only five (35.7%) featured a positive result by the Idylla SARS-CoV-2 Test.

Conclusions: We demonstrated that the Idylla SARS-CoV-2 Test may represent a valid, fast, highly sensitive and specific RT-PCR test for the identification of SARS-CoV-2 infection.
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http://dx.doi.org/10.1136/jclinpath-2021-207516DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8042579PMC
April 2021

Management of anaphylaxis due to COVID-19 vaccines in the elderly.

Allergy 2021 Apr 2. Epub 2021 Apr 2.

Regional Ministry of Health of Andalusia, Seville, Spain.

Older adults, especially men and/or those with diabetes, hypertension and/or obesity, are prone to severe COVID-19. In some countries, older adults, particularly those residing in nursing homes, have been prioritised to receive COVID-19 vaccines due to high risk of death. In very rare instances,the COVID-19 vaccines can induce anaphylaxis, and the management of anaphylaxis in older people should be considered carefully. An ARIA-EAACI-EuGMS (Allergic Rhinitis and its Impact on Asthma, European Academy of Allergy and Clinical Immunology, and European Geriatric Medicine Society)Working Group has proposed some recommendations for older adults receiving the COVID-19 vaccines. Anaphylaxis to COVID-19 vaccines is extremely rare (from 1 per 100,000 to 5 per million injections). Symptoms are similar in younger and older adults but they tend to be more severe in the older patients. Adrenaline is the mainstay treatment and should be readily available. A flowchart is proposed to manage anaphylaxis in the older patients.
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http://dx.doi.org/10.1111/all.14838DOI Listing
April 2021

Diagnostic and infection control strategies for Clostridioides difficile infections in a setting of high antimicrobial resistance prevalence.

Infez Med 2021 Mar;29(1):70-78

"San Paolo" Hospital, Naples, Italy.

Clostridioides difficile (CD) is a major nosocomial pathogen and the leading cause of antibiotic-associated diarrhoea. In light of the strong association between antimicrobial use and CD infections (CDI), it may be hypothesised that areas at higher prevalence of antimicrobial resistance, like the region of Campania in southern Italy, could also have a higher rate of CDI. In this multicentre, region-based, prospective study, we analysed such issues, exploiting CDI incidence data collected from local hospitals. In 2016, the Italian National Centre for Disease Control supported a project involving three Italian regions: Friuli Venezia Giulia, Lazio and Campania. In Campania, a network of 49 hospitals willing to participate in the project was created. The project consisted of two phases: a survey on practice patterns concerning CDI and an epidemiological surveillance study. We identified a stringent need to improve awareness about CDI among the regional health-care community, as a widespread lack of surveillance programmes for CDI control was observed (existing in only 40% of participating facilities). Moreover, almost half of the participating hospitals (n=16, 43%) had no standardised procedures or protocols to control and prevent CDI. In the second phase of the study, we collected data of CDI cases during a six-month surveillance programme. In all, 87 CDI cases were observed, for a total of 903,334 patient bed-days and 122,988 admissions. According to the above data, CDI incidence was 0.96 cases/10000 patient bed-days, much lower than expected based on prior studies conducted elsewhere. The results of our study suggest CDI remains a rather neglected clinical issue in Campania. Despite a high burden of antimicrobial resistance and antimicrobial use in our geographic setting, we observed a very low incidence of CDI. Such a low incidence could be explained by underdiagnosis, but could also be related to actual diet, the lower patient age or the specific genetic background. However, further studies are warranted to either confirm or rebut the above hypotheses.
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March 2021

Risk of SARS-CoV-2 Transmission in Health Care Personnel Working in a Pediatric COVID-19 Unit.

Hosp Pediatr 2021 03 23;11(3):e42-e47. Epub 2020 Dec 23.

Section of Pediatrics, Departments of Translational Medical Science and.

Objectives: The paucity of symptoms and the difficulties in wearing personal protective equipment make children a potential source of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection for health care workers (HCWs). Previous experience in pediatric settings reported high rate of intrahospital SARS-CoV-2 transmission in HCWs caring for children. We aimed at investigating the rate and determinants of SARS-CoV-2 infection among HCWs working in a regional reference center in the Southern Italy.

Methods: A prospective observational study was conducted to monitor the occurrence of SARS-CoV-2 infections among HCWs and investigate the relation between the infection rate and hours of exposure or number and characteristics of procedures, including nasopharyngeal swab, high-flow oxygen delivery, suctioning of airway secretions, sputum induction, and nebulizer administration.

Results: After 5 months of monitoring, 425.6 hours of SARS-CoV-2 exposure (18.5 hours per person), and 920 hospital procedures, no case of nosocomial transmission was reported among the 23 HCWs enrolled in the study.

Conclusions: The application of stringent preventive measures, also outside the area dedicated to patients' care, can effectively control infection spreading also in pediatric settings.
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http://dx.doi.org/10.1542/hpeds.2020-003855DOI Listing
March 2021

Prevalence of SARS-CoV-2 Antibodies in Multiple Sclerosis: The Hidden Part of the Iceberg.

J Clin Med 2020 Dec 16;9(12). Epub 2020 Dec 16.

Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Sciences and Odontostomatology, University of Naples "Federico II", 80138 Naples, Italy.

Background: We compared the prevalence of SARS-CoV-2 IgG/IgM in multiple sclerosis (MS), low-risk, and high-risk populations and explored possible clinical correlates.

Methods: In this cross-sectional study, we recruited MS patients, low-risk (university staff from non-clinical departments), and high-risk individuals (healthcare staff from COVID-19 wards) from 11 May to 15 June 2020. We used lateral flow immunoassay to detect SARS-CoV-2 IgG and IgM. We used t-test, Fisher's exact test, chi square test, or McNemar's test, as appropriate, to evaluate between-group differences.

Results: We recruited 310 MS patients (42.3 ± 12.4 years; females 67.1%), 862 low-risk individuals (42.9 ± 13.3 years; females 47.8%), and 235 high-risk individuals (39.4 ± 10.9 years; females 54.5%). The prevalence of SARS-CoV-2 IgG/IgM in MS patients (n = 9, 2.9%) was significantly lower than in the high-risk population (n = 25, 10.6%) ( < 0.001), and similar to the low-risk population (n = 11, 1.3%) ( = 0.057); these results were also confirmed after random matching by age and sex (1:1:1). No significant differences were found in demographic, clinical, treatment, and laboratory features. Among MS patients positive to SARS-CoV-2 IgG/IgM (n = 9), only two patients retrospectively reported mild and short-lasting COVID-19 symptoms.

Conclusions: MS patients have similar risk of SARS-CoV-2 infection to the general population, and can be asymptomatic from COVID-19, also if using treatments with systemic immunosuppression.
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http://dx.doi.org/10.3390/jcm9124066DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7766741PMC
December 2020

Health-care organization for the management and surveillance of SARS-CoV-2 infection in children during pandemic in Campania region, Italy.

Ital J Pediatr 2020 Nov 16;46(1):170. Epub 2020 Nov 16.

Department of Translational Medical Sciences - Paediatrics Section, University of Naples Federico II, via Pansini 5, 80134, Naples, Italy.

Background: In comparison with adults, severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection in children has a milder course. The management of children with suspected or confirmed coronavirus disease (COVID-19) needs to be appropriately targeted.

Methods: We designed a hub-and-spoke system to provide healthcare indications based on the use of telemedicine and stringent admission criteria, coordinate local stakeholders and disseminate information.

Result: Between March 24th and September 24th 2020, the Hub Centre managed a total of 208 children (52% males, median age, 5.2, IQR 2-9.6 years) with suspected or confirmed COVID-19. Among them, 174 were managed in cooperation with family pediatricians and 34 with hospital-based physicians. One hundred-four (50%) received a final diagnosis of SARS-CoV-2 infection. Application of stringent criteria for hospital admission based on clinical conditions, risk factors and respect of biocontainment measures, allowed to manage the majority of cases (74, 71.1%) through telemedicine. Thirty children (28%) were hospitalized (median length 10 days, IQR 5-19 days), mainly due to the presence of persistent fever, mild respiratory distress or co-infection occurring in infant or children with underlying conditions. However, the reasons for admission slightly changed over time.

Conclusion: An hub-and-spoke system is effective in coordinate territorial health-care structures involved in management paediatric COVID-19 cases through telemedicine and the definition of stringent hospital admission criteria. The management of children with COVID-19 should be based on clinical conditions, assessed on a case-by-case critical evaluation, as well as on isolation measures, but may vary according to local epidemiological changes.
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http://dx.doi.org/10.1186/s13052-020-00928-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7667478PMC
November 2020

Optimising triage procedures for patients with cancer needing active anticancer treatment in the COVID-19 era.

ESMO Open 2020 09;5(5):e000885

Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Campania, Italy.

Background: Immunosuppression induced by anticancer therapy in a COVID-19-positive asymptomatic patient with cancer may have a devastating effect and, eventually, be lethal. To identify asymptomatic cases among patients receiving active cancer treatment, the Federico II University Hospital in Naples performs rapid serological tests in addition to hospital standard clinical triage for COVID-19 infection.

Methods: From 6 to 17 April 2020, all candidates for chemotherapy, radiotherapy or target/immunotherapy, if negative at the standard clinical triage on the day scheduled for anticancer treatment, received a rapid serological test on peripheral blood for COVID-19 IgM and IgG detection. In case of COVID-19 IgM and/or IgG positivity, patients underwent a real-time PCR (RT-PCR) SARS-CoV-2 test to confirm infection, and active cancer treatment was delayed.

Results: Overall 466 patients, negative for COVID-19 symptoms, underwent serological testing in addition to standard clinical triage. The average age was 61 years (range 25-88 years). Most patients (190, 40.8%) had breast cancer, and chemotherapy with or without immunotherapy was administered in 323 (69.3%) patients. Overall 433 (92.9%) patients were IgG-negative and IgM-negative, and 33 (7.1%) were IgM-positive and/or IgG-positive. Among the latter patients, 18 (3.9%), 11 (2.4%) and 4 (0.9%) were IgM-negative/IgG-positive, IgM-positive/IgG-negative and IgM-positive/IgG-positive, respectively. All 33 patients with a positive serological test, tested negative for RT-PCR SARS-CoV-2 test. No patient in our cohort developed symptoms suggestive of active COVID-19 infection.

Conclusion: Rapid serological testing at hospital admission failed to detect active asymptomatic COVID-19 infection. Moreover, it entailed additional economic and human resources, delayed therapy administrationand increased hospital accesses.
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http://dx.doi.org/10.1136/esmoopen-2020-000885DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7507249PMC
September 2020

COVID-19 prevention and multiple sclerosis management: The SAFE pathway for the post-peak.

Mult Scler Relat Disord 2020 Sep 10;44:102282. Epub 2020 Jun 10.

Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Science and Odontostomatology, Federico II University of Naples, Italy.

Background: We hereby report on our experience from Naples (South Italy), where the peak of coronavirus disease 2019 (COVID-19) has already passed.

Methods: Assuming that COVID-19 will be circulating until vaccination and/or herd immunity is achieved (possibly not earlier than 2021), we have developed a protocol for the long-term management of multiple sclerosis (MS).

Results: We have defined a pathway for the access to the MS Centre with logistic, preventative and clinical recommendations, and have also included 14-day self-isolation and COVID-19 testing before some disease modifying treatments.

Discussion: Overall, we believe our experience could be helpful for MS management in the upcoming months.
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http://dx.doi.org/10.1016/j.msard.2020.102282DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7283048PMC
September 2020

The application of Lean Six Sigma methodology to reduce the risk of healthcare-associated infections in surgery departments.

J Eval Clin Pract 2017 Jun 18;23(3):530-539. Epub 2016 Nov 18.

Department of Public Health, University "Federico II" of Naples, Naples, Italy.

Rationale: Nowadays, the monitoring and prevention of healthcare-associated infections (HAIs) is a priority for the healthcare sector.

Aims And Objectives: In this article, we report on the application of the Lean Six Sigma (LSS) methodology to reduce the number of patients affected by sentinel bacterial infections who are at risk of HAI.

Methods: The LSS methodology was applied in the general surgery department by using a multidisciplinary team of both physicians and academics. Data on more than 20 000 patients who underwent a wide range of surgical procedures between January 2011 and December 2014 were collected to conduct the study using the departmental information system. The most prevalent sentinel bacteria were determined among the infected patients. The preintervention (January 2011 to December 2012) and postintervention (January 2013 to December 2014) phases were compared to analyze the effects of the methodology implemented. The methodology allowed the identification of variables that influenced the risk of HAIs and the implementation of corrective actions to improve the care process, thereby reducing the percentage of infected patients.

Results: The improved process resulted in a 20% reduction in the average number of hospitalization days between preintervention and control phases, and a decrease in the mean (SD) number of days of hospitalization amounted to 36 (15.68), with a data distribution around 3 σ. The LSS is a helpful strategy that ensures a significant decrease in the number of HAIs in patients undergoing surgical interventions. The implementation of this intervention in the general surgery departments resulted in a significant reduction in both the number of hospitalization days and the number of patients affected by HAIs.

Conclusions: This approach, together with other tools for reducing the risk of infection (surveillance, epidemiological guidelines, and training of healthcare personnel), could be applied to redesign and improve a wide range of healthcare processes.
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http://dx.doi.org/10.1111/jep.12662DOI Listing
June 2017

Season of birth and Parkinson's disease: possible relationship?

Neurol Sci 2015 Aug 26;36(8):1457-62. Epub 2015 Mar 26.

Department of Public Health, Federico II University of Naples, Naples, Italy,

The amount of sun exposure in early life and consequent vitamin D3 level may influence the risk of developing Parkinson's disease (PD). Yet few studies have previously investigated birth trends in PD related to a possible seasonality and sun exposure. The aim of this study was to investigate a possible relationship between PD risk and sun exposure looking at seasonal birth variation of PD subjects in the homogenous geographic area of Naples, Italy. We selected 898 PD subjects and matched with 1796 controls. McNemar's test with Bonferroni correction and autocorrelation were used to test seasonality in birth trends. No difference was found for the month and season of birth between PD subjects and controls. We found a 3.3 % increase of PD female subjects born in September (3.3 %) and 4.1 % increase of PD male subjects born in spring comparing to controls but were not significant after Bonferroni correction. This study evaluated for the first time the seasonal birth trends in relation to PD risk in a Southern European population. We found no association between seasonal birth variations and risk of PD.
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http://dx.doi.org/10.1007/s10072-015-2183-4DOI Listing
August 2015

Serum in vivo and in vitro activity of single dose of ertapenem in surgical obese patients for prevention of SSIs.

Obes Surg 2013 Jul;23(7):911-9

Department of General, Geriatric, Oncologic Surgery and Advanced Technologies, Federico II University, Naples, Italy.

Background: Despite progress made in the control of post-operative infections, the incidence of surgical site infections (SSIs) is still high. An improper perioperative antibiotic use can expose patients to the risk of resistant microorganisms, and, in surgical obese patients, the drug dosage and infusion time are critical points. The aim of our study was to evaluate the effectiveness of ertapenem in the prophylaxis of SSIs in obese patients undergoing general or bariatric surgery.

Methods: A total of 63 obese patients, candidates for several surgical interventions, were enrolled and divided into two groups. Patients received antibiotic prophylaxis before surgery: the case group received venous infusion of ertapenem; the control group received standard prophylaxis. Serum samples were tested for antimicrobial activity against Gram-positive and Gram-negative bacteria.

Results: After single-dose ertapenem in obese patients, we registered in vitro activity of sera against the growth of non-extended beta lactamase (ESBL)-producing Escherichia coli, Proteus mirabilis, Citrobacter freundii, Enterobacter cloacae, and non-ESBL-producing Klebsiella pneumoniae. Moreover, methicillin-sensitive Staphylococcus aureus and Streptococcus viridans were also inhibited. We found in vivo efficacy according to clinical monitoring: at the weekly and monthly follow-ups, one patient in the case group and six patients in the control group presented superficial incisional SSIs.

Conclusions: These preliminary results are suggestive of the efficacy of ertapenem in perioperative prophylaxis of SSIs in obese patients; however, they need to be confirmed by further investigations and more defined trials.
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http://dx.doi.org/10.1007/s11695-013-0879-1DOI Listing
July 2013