Multi-locus sequence typing of Escherichia coli isolates with acquired ampC genes and ampC promoter mutations

© 2016 Elsevier Inc. Multi-locus sequence typing was used to reveal a high degree of diversity amongst the E. coli isolates with AmpC plasmid genes, and a high prevalence of the −32 mutation present

Neonatal Safety Information Reported to the FDA During Drug Development Studies.

BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015. METHODS: FDA databases were searched for BPCA and/or PREA studies that enrolled neonates. Studies that enrolled a minimum of 3 neonates were analyzed for the presence and content of neonatal safety data. RESULTS: The analysis identified 40 drugs that were studied in 3 or more neonates. Of the 40 drugs, 36 drugs received a pediatric labeling change as a result of studies between 1998 and 2015, that included information from studies including neonates. Fourteen drugs were approved for use in neonates. Clinical trials for 20 of the drugs reported serious adverse events (SAEs) in neonates. The SAEs primarily involved cardiovascular events such as bradycardia and/or hypotension or laboratory abnormalities such as anemia, neutropenia, and electrolyte disturbances. Deaths were reported during studies of 9 drugs. CONCLUSIONS: Our analysis revealed that SAEs were reported in studies involving 20 of the 40 drugs evaluated in neonates, with deaths identified in 9 of those studies. Patients enrolled in studies were often critically ill, which complicated determination of whether an adverse event was drug-related. We conclude that the traditional means for collecting safety information in drug development trials needs to be adjusted for neonates and will require the collaboration of regulators, industry, and the clinical and research communities to establish appropriate definitions and reporting strategies for the neonatal population

Participatory ecology for \u27Agriculture of the Middle\u27: Developing tools and partnerships to bridge gaps among science, people and policy in landscape change

Based on findings of this project, the adaptive landscape changes needed to significantly incorporate perennial vegetation strategies into Iowa\u27s Corn Belt-dominated agriculture are possible if a coordinated strategy of change is coupled across three scales: field/individual, landscape/community, and regional/institutional

Chromosomal ampC mutations in cefpodoxime-resistant ESBL-negative uropathogenic escherichia coli

AmpC beta-lactamase is an enzyme commonly produced by Escherichia coli that causes resistance to cephalosporins and penicillins. Enzyme production is controlled by the strength of the promoter encoded by the chromosomal ampC gene, with the level of production affected by the presence of certain mutations in this region. This study sets out to determine the prevalence of ampC promoter mutations present in a group of uropathogenic E. coli strains. A total of 50 clinical strains of E. coli were collected from urine samples between June 2011 and November 2011. Strains were investigated for the presence of mutations in the chromosomal ampC promoter region by amplification and sequencing of a 271 bp product. The presence of ampC-carrying plasmids derived from other species was also determined, to exclude these from further analysis. ampC-carrying plasmids were found in 10 of the 50 strains, all of which were of the CIT-type. Analysis of the chromosomal ampC promoter region in the 40 remaining strains showed mutations at 16 different positions, with 18 different genotype patterns detected overall. The most common ampC chromosomal mutation, present in 25 of 40 strains, was a T→A transition at position -32. This mutation has been shown by others to increase enzyme production by up to 46-fold. Altogether, three separate mutations (-32, -42 and -13ins) were present in 90% of the 40 non-plasmid strains, indicating a strong association with the resistance observed. It appears, therefore, that the majority of AmpC-mediated resistance in E. coli can be accounted for by just three point mutations in the chromosome

A reflective conversation with Kobus Maree, Faculty of Education, University of Pretoria, South Africa

Always regarded as somewhat of an ‘outsider’ (the child of an Englishspeaking (Catholic) mother and an Afrikaans (Protestant) father in an exclusively Afrikaans milieu) and growing up extremely poor, seeing the hardship of others and realising howmuch talentwas going to waste, Kobus Maree took a particular interest in gifted disadvantaged persons. A marginalised loner, he almost inevitably developed creative abilities and took a keen interest in creativity, giftedness and the education of gifted, disadvantaged learners. As an adult, his research showed that many teachers in South Africa have to contend with the generally poor socioeconomic background of learners. A dire need for appropriate teacher and learner support materials, and school environments that are not conducive to achievement (including inadequate facilities, overcrowded classrooms, lack of teacher and learner support materials). SouthAfrica is at a critical stage in its education. It is therefore important for educators to teach emotional intelligence in their classrooms. Our biggest challenge will be tomaintain and enhance vitality in gifted education in a dynamic, ever-evolving environment. A combination of scholarly leadership and strategic management to support gifted learners is important. We should do all we can to promote societal transformation and diversity, focussing anew on underrepresented groups (women and ethnic groups) who show promise and support them. The widest array of partners possible including the big institutional players, the entire teaching fraternity (including government departments), nongovernmental organisations and miscellaneous interest groups together should develop strategic, rolling five-year plans and make gifted education a priority.http://gei.sagepub.comam201