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1دورية أكاديمية
المؤلفون: Riddell, Amy, Cook, Aislinn, Khavessian, Nathalie, Ellis, Sally, Bilardi, Davide, Correia, Erika, Kostyanev, Tomislav, Nardone, Alessandra, Russell, Neal, Vilken, Tuba, Stohr, Wolfgang, Adhisivam, Bethou, de Moraes, Iana Rosa Alves, Ahmed, Nawshad Uddin, Bekker, Adrie, Berezin, Eitan Naaman, Boonkasidecha, Suppawat, Carvalheiro, Cristina G., Chauhan, Prachi, Chiurchiu, Sara, Chorafa, Elisavet, Dramowski, Angela, Madhusudhan, D.S., Feng, Jinxing, Jia, Shengnan, Kong, Yuan, Kyohere, Mary, Kontou, Angeliki, Lochindarat, Sorasak, De Luca, Maia, Mphaphuli, Aripfani, Mussi-Pinhata, Marisa M., Murunga, Sheila, Nakwa, Firdose Lambey, Nangia, Sushma, Nassolo, Erinah, Hoang, Ngoc Thi Bin, Obiero, Christina W., Olson, Linus, Ping, Wang, Plakkal, Nishad, Prasad, Priyanka, Preedisripipat, Kanchana, Rahman, Sheikh Wasik, Seef, Tiffany, Sukrakanchana, Pra-ornsuda, Thomas, Reenu, Yu, Zhang, Zhang, Qiaoru, Walker, A. Sarah, Bielicki, Julia, Heath, Paul T., Sharland, Michael, Munera-Huertas, Tatiana
المصدر: 2079-6382 ; Antibiotics
مصطلحات موضوعية: Pharmacology. Therapy
الوصف: Neonatal sepsis is a significant cause of mortality and morbidity in low- and middle-income countries. To deliver high-quality data studies and inform future trials, it is crucial to understand the challenges encountered when managing global multi-centre research studies and to identify solutions that can feasibly be implemented in these settings. This paper provides an overview of the complexities faced by diverse research teams in different countries and regions, together with actions implemented to achieve pragmatic study management of a large multi-centre observational study of neonatal sepsis. We discuss specific considerations for enrolling sites with different approval processes and varied research experience, structures, and training. Implementing a flexible recruitment strategy and providing ongoing training were necessary to overcome these challenges. We emphasize the attention that must be given to designing the database and monitoring plans. Extensive data collection tools, complex databases, tight timelines, and stringent monitoring arrangements can be problematic and might put the study at risk. Finally, we discuss the complexities added when collecting and shipping isolates and the importance of having a robust central management team and interdisciplinary collaborators able to adapt easily and make swift decisions to deliver the study on time and to target. With pragmatic approaches, appropriate training, and good communication, these challenges can be overcome to deliver high-quality data from a complex study in challenging settings through a collaborative research network.
العلاقة: info:eu-repo/semantics/altIdentifier/isi/000998933400001
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2دورية أكاديمية
المؤلفون: Russell, Neal J., Stohr, Wolfgang, Plakkal, Nishad, Cook, Aislinn, Berkley, James A., Adhisivam, Bethou, Agarwal, Ramesh, Ahmed, Nawshad Uddin, Balasegaram, Manica, Ballot, Daynia, Bekker, Adrie, Berezin, Eitan Naaman, Bilardi, Davide, Boonkasidecha, Suppawat, Carvalheiro, Cristina G., Chami, Neema, Chaurasia, Suman, Chiurchiu, Sara, Colas, Viviane Rinaldi Favarin, Cousens, Simon, Cressey, Tim R., de Assis, Ana Carolina Dantas, Dien, Tran Minh, Ding, Yijun, Dung, Nguyen Trong, Dong, Han, Dramowski, Angela, Madhusudhan, D.S., Dudeja, Ajay, Feng, Jinxing, Glupczynski, Gérald, Goel, Srishti, Goossens, Herman, Hao, Doan Thi Huong, Khan, Mahmudul Islam, Huertas, Tatiana Munera, Islam, Mohammad Shahidul, Jarovsky, Daniel, Khavessian, Nathalie, Khorana, Meera, Kontou, Angeliki, Kostyanev, Tomislav, Laoyookhon, Premsak, Lochindarat, Sorasak, Larsson, Mattias, De Luca, Maia, Malhotra, Surbhi, Mondal, Nivedita, Mundhra, Nitu, Musoke, Philippa, Mussi-Pinhata, Marisa M., Nanavati, Ruchi, Nakwa, Firdose, Nangia, Sushma, Nankunda, Jolly, Nardone, Alessandra, Nyaoke, Borna, Obiero, Christina W., Owor, Maxensia, Ping, Wang, Preedisripipat, Kanchana, Qazi, Shamim, Qi, Lifeng, Ramdin, Tanusha, Riddell, Amy, Romani, Lorenza, Roysuwan, Praewpan, Saggers, Robin, Roilides, Emmanuel, Saha, Samir K., Sarafidis, Kosmas, Tusubira, Valerie, Thomas, Reenu, Velaphi, Sithembiso, Vilken, Tuba, Wang, Xiaojiao, Wang, Yajuan, Yang, Yonghong, Zunjie, Liu, Ellis, Sally, Bielicki, Julia A., Walker, A. Sarah, Heath, Paul T., Sharland, Mike
المصدر: 1549-1277 ; PLoS medicine
مصطلحات موضوعية: Human medicine
الوصف: BackgroundThere is limited data on antibiotic treatment in hospitalized neonates in low- and middle-income countries (LMICs). We aimed to describe patterns of antibiotic use, pathogens, and clinical outcomes, and to develop a severity score predicting mortality in neonatal sepsis to inform future clinical trial design.Methods and findingsHospitalized infants <60 days with clinical sepsis were enrolled during 2018 to 2020 by 19 sites in 11 countries (mainly Asia and Africa). Prospective daily observational data was collected on clinical signs, supportive care, antibiotic treatment, microbiology, and 28-day mortality. Two prediction models were developed for (1) 28-day mortality from baseline variables (baseline NeoSep Severity Score); and (2) daily risk of death on IV antibiotics from daily updated assessments (NeoSep Recovery Score). Multivariable Cox regression models included a randomly selected 85% of infants, with 15% for validation.A total of 3,204 infants were enrolled, with median birth weight of 2,500 g (IQR 1,400 to 3,000) and postnatal age of 5 days (IQR 1 to 15). 206 different empiric antibiotic combinations were started in 3,141 infants, which were structured into 5 groups based on the World Health Organization (WHO) AWaRe classification. Approximately 25.9% (n = 814) of infants started WHO first line regimens (Group 1-Access) and 13.8% (n = 432) started WHO second-line cephalosporins (cefotaxime/ceftriaxone) (Group 2-"Low" Watch). The largest group (34.0%, n = 1,068) started a regimen providing partial extended-spectrum beta-lactamase (ESBL)/pseudomonal coverage (piperacillin-tazobactam, ceftazidime, or fluoroquinolone-based) (Group 3-"Medium" Watch), 18.0% (n = 566) started a carbapenem (Group 4-"High" Watch), and 1.8% (n = 57) a Reserve antibiotic (Group 5, largely colistin-based), and 728/2,880 (25.3%) of initial regimens in Groups 1 to 4 were escalated, mainly to carbapenems, usually for clinical deterioration (n = 480; 65.9%).A total of 564/3,195 infants (17.7%) were blood culture ...
العلاقة: info:eu-repo/semantics/altIdentifier/isi/001004688500001
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3دورية أكاديمية
المؤلفون: Nardone, A., Tischer, Annedore, Andrews, N., Backhouse, Jo, Theeten, Heidi
المصدر: 0042-9686 ; Bulletin of the World Health Organization
وصف الملف: pdf
العلاقة: info:eu-repo/semantics/altIdentifier/isi/000253079700011
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4دورية أكاديمية
المؤلفون: Nardone, A., Anastassopoulou, C.G., Theeten, Heidi, van Damme, Pierre
المصدر: 0950-2688 ; Epidemiology and infection
مصطلحات موضوعية: Human medicine
الوصف: To inform current and future vaccination strategies, we describe the seroepidemiology of hepatitis B virus (HBV) infection in ten representative European countries using standardized serology that allowed international comparisons. Between 1996 and 2003, national serum banks were compiled by collecting residual sera or by community sampling; sera were then tested by each country using its preferred enzyme immunoassays and testing algorithm, and assay results were standardized. Information on current and past HBV vaccination programmes in each country was also collected. Of the ten countries, six reported low levels (<3%) of antibodies against HBV core antigen (anti-HBc). Of the eight countries testing for HBV surface antigen (HBsAg), the highest prevalence was reported in Romania (5·6%) and in the remaining seven countries prevalence was <1%. Universal HBV vaccination programmes had been established in seven countries as recommended by the World Health Organization, but the seroprevalence of antibodies against HBsAg (anti-HBs) was lower than the reported vaccine coverage in three countries. Regular serological surveys to ascertain HBV status within a population, such as reported here, provide important data to assess the need for and to evaluate universal HBV vaccination programmes.
العلاقة: info:eu-repo/semantics/altIdentifier/isi/000267298400008
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5دورية أكاديمية
المؤلفون: Nardone, A., de Ory, F., Carton, M., van Damme, Pierre
المصدر: 0264-410X ; Vaccine
الوصف: The European sero-epidemiology network (ESEN2) aims to standardise serological surveillance of varicella zoster virus (VZV) in 11 participant countries. In each country, serum banks were collected between 1996 and 2003 and tested for VZV antibodies. Assay results were standardised so that international comparisons could be made. Age-specific forces of infection were calculated for three age groups (<5, 5¨C9 and ¡Ý10 years of age) and used to estimate the base reproduction number (R0) and the herd immunity threshold (H). Most VZV infection occurred in childhood, but there was a wide variation in transmissibility, with R0 ranging from 16.9 in the Netherlands to 3.3 in Italy. Herd immunity thresholds varied from 70% in Italy to 94% in the Netherlands. There are substantial differences in VZV sero-epidemiology within the European region, which will need to be taken into account in designing national policies regarding VZV vaccination.
وصف الملف: pdf
العلاقة: info:eu-repo/semantics/altIdentifier/isi/000251103600019
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6دورية أكاديمية
المؤلفون: Kafatos, G., Anastassopoulou, C., Nardone, A., van Damme, Pierre
المصدر: 1352-0504 ; Journal of viral hepatitis
العلاقة: info:eu-repo/semantics/altIdentifier/isi/000245983200006
