safe Diversity and inclusion plan 2019-2022 / Australian Maritime Safety Authority. By www.catalog.slsa.sa.gov.au Published On :: Full Article
safe Florida High Court Approves Request for Grand Jury Probe of School Safety By feedproxy.google.com Published On :: Tue, 05 Mar 2019 00:00:00 +0000 The Florida supreme court has ordered a statewide grand jury with a broad mandate to investigate school safety. Full Article Florida
safe National transportation safety board public forum on alcohol and drug safety education. By search.wellcomelibrary.org Published On :: Springfield, Virginia : National Technical Information Service, 1986. Full Article
safe Staying safe in the Library By feedproxy.google.com Published On :: Wed, 18 Mar 2020 05:32:26 +0000 We want to you stay safe while you’re visiting the Library. Full Article
safe Fresh-cut fruits and vegetables : technologies and mechanisms for safety control By dal.novanet.ca Published On :: Fri, 1 May 2020 19:44:43 -0300 Callnumber: OnlineISBN: 9780128165393 (electronic bk.) Full Article
safe How to Stay Safe on the Internet, Part 2: Take Canaries Into the Data Mine By www.technewsworld.com Published On :: 2020-04-24T10:58:19-07:00 More than any other factor, it is our asset that determines our adversary. For most of us, our asset is the corpus of sensitive personal details used for online transactions. This all comes down to how much data an adversary can glean from you, and how thoroughly it can analyze it. If your data passes through some software or hardware, its developer or maintainer enjoys some measure of control. Full Article
safe How to Stay Safe on the Internet, Part 3: Drive the Black Hatters Mad By www.technewsworld.com Published On :: 2020-05-01T11:18:34-07:00 Like conventional criminals, criminal hackers choose easy, lucrative targets. One group in the crosshairs is made up of companies that have data on millions of users, such as private sector entities with a Web presence. Why go after one user at a time when data is collected in one place? Criminal hackers also like to hunt small organizations that have modest capital but weak information security. Full Article
safe Six Online Courses About Europe to Take Before You Can Safely Travel There Again By www.smithsonianmag.com Published On :: Mon, 27 Apr 2020 18:09:59 +0000 Sheltering in place doesn’t mean you can’t study up for your next European adventure Full Article
safe Municipality of Qikiqtarjuaq faces 5 charges under Nunavut Safety Act By www.cbc.ca Published On :: Fri, 8 May 2020 21:43:39 EDT The N.W.T. and Nunavut Workers’ Safety and Compensation Commission says it filed multiple charges in the Nunavut Court of Justice under the Nunavut Safety Act on May 1. Full Article News/Canada/North
safe Safer Internet Day 2015 By cert-mu.govmu.org Published On :: Mon, 06 Nov 2017 12:21:39 GMT Safer Internet Day (SID) is an international education and awareness-raising effort spanning more than 100 countries around the globe to promote safer and more responsible use of online technology and mobile phones, especially amongst children and young people across the world. Mauritius is among one of the very first countries where government has taken keen interest to protect children and youngsters on the Internet. In this context, a Child Online Safety Action Plan was developed by the National Computer Board (NCB) and endorsed by the cabinet in 2009. Following the aproval of the action plan, number of activities have been started on Child Online Safety since 2009 including organisation of the Safer Internet Day. This year is the 6th edition of Safer Internet Day which will be celebrated in Mauritius. On this occasion, CERT-MU, a division of the National Computer Board is organising several activities. The activities are as follows: A half day workshop with theme "Let's create a better Internet together" in collaboration with the Ministry of Technology, Communication and Innovation and the Ministry of Education and Human Resources, Tertiary Education and Scientific Research. The proposed workshop is targeted towards State and Private secondary school students to sensitise them on the impact of threats and consequences that improper use of the Internet may have on the youth. Awareness sessions on “Internet Safety” will be carried out for secondary school students (State and Private) in all four school zones of the country. These sessions will highlight issues like sexting, sextortion, cyber bullying, online predators and identity theft etc. Organisation of awareness sessions on “Dangers of the Internet” for secondary school teachers (State and Private) in all four school zones during the school holidays. Trainings on the Dangers of the Internet and how to help youngsters choose a better way of socialising in the virtual world will be organised for the teachers of secondary schools. Awareness sessions for Parents, Senior Citizens and House Wives on "Secure Usage of Internet". Parents, Grandparents and House Wives need to be aware of the dangers on the Internet and how to protect their kids online. An awareness session will be organised to address this issue with parents, in collaboration with the PTA of secondary schools. The Senior Citizens and House Wives sessions will take place in NCB cyber caravans and community welfare centres. Dissemination of brochures on "Child Online Protection" to the students and teachers. Click here to visit the Safer Internet Day website. Full Article
safe Safer Internet Day 2020 By cert-mu.govmu.org Published On :: Mon, 16 Mar 2020 06:54:48 GMT The Computer Emergency Response Team of Mauritius, a division of the National Computer Board operating under the aegis of the Ministry of Technology, Communication & Innovation organised a full day workshop with the theme, Together for a better Internet, on the occasion of the Safer Internet Day 2020. The event was held at Shri Atal Bihari Vajpayee Tower, Ebène on Wednesday 12th February 2020. The workshop was organized in collaboration with the Ministry of Education, Tertiary Education, Science and Technology. The event was officially opened by the Honourable Deepak Balgobin, Minister of Technology, Communication & Innovation and was attended by some 120 University students and 60 invitees. Full Article
safe Workshop on Internet Safety for kids with special needs By cert-mu.govmu.org Published On :: Mon, 16 Mar 2020 07:01:09 GMT The Computer Emergency Response Team of Mauritius (CERT-MU), a division of the National Computer Board operating under the aegis of the Ministry of Technology, Communication & Innovation organised a half day workshop with the title “Internet Safety for kids with special needs” on Wednesday, 19th February 2020 at Quartier Militaire State Secondary School (Girls). The workshop was organized in collaboration with the Ministry of Education and Human Resources, Tertiary Education and Scientific Research. The objective of the workshop was to showcase existing online dangers and, at the same time, promote the responsible use of the Internet amongst kids with special needs. A presentation was delivered by the Computer Emergency Response Team of Mauritius with focus on the responsible use of the internet and underlying dangers such as Online Predators, Sexting, Sextortion and Cyberbullying. Some 20 Special Education Needs (SEN) schools were present. Full Article
safe CPMI and IOSCO share authorities´ experiences in cooperation to increase FMI safety and efficiency By www.bis.org Published On :: 2019-12-10T14:00:00Z Press release: CPMI and IOSCO share authorities´ experiences in cooperation to increase FMI safety and efficiency, 10 December 2019 Full Article
safe 9-year-old girl found safe after getting lost in Lanaudière woods By www.cbc.ca Published On :: Thu, 7 May 2020 21:50:54 EDT A 9-year-old girl was found safe in the Lanaudière region, after she had gone missing Thursday evening in the woods behind her family's second home. Full Article News/Canada/Montreal
safe Is it safe to give cards and flowers this Mother's Day? Your COVID-19 questions answered By www.cbc.ca Published On :: Fri, 8 May 2020 04:00:00 EDT We're answering your questions about the pandemic. Send yours to COVID@cbc.ca and we’ll answer as many as we can. We’ll publish a selection of answers every weekday online, and also put some questions to the experts during The National and on CBC News Network. Full Article News
safe Union raises concerns over lack of safety inspections after Manitoba construction worker dies on the job By www.cbc.ca Published On :: Fri, 8 May 2020 19:57:33 EDT The union that represents thousands of Manitoba workers is asking what safety protocols were in place when a construction worker was killed after a trench wall collapsed on him earlier this week. Full Article News/Canada/Manitoba
safe FCA's Windsor Assembly Plant, Ford looking to restart this May as union works to ensure safety By www.cbc.ca Published On :: Fri, 8 May 2020 08:21:41 EDT As automakers look to restart the industry, union representatives are looking to ensure safety is the number one priority for workers. Full Article News/Canada/Windsor
safe No lead is safe as jaw-dropping shots making for memorable Brier By www.cbc.ca Published On :: Wed, 4 Mar 2020 14:48:59 EST Just when you thought you watched the best shot of the Brier, another best shot of the Brier appears at the 2020 Canadian men's curling championship being held in Kingston, Ont. Full Article Sports/Olympics/Winter Sports/Curling
safe Fire safety and evacuation exercise at BER postponed until summer / No effect on commissioning By www.berlin-airport.de Published On :: Thu, 16 Apr 2020 11:05:00 +0200 In light of the regulations on hygiene and gatherings in connection with the global corona pandemic, a fire safety and evacuation exercise, which was scheduled to take place on 29 April in Terminal T1 and the BER railway station, has been postponed yest... Full Article
safe Teacher-Candidates Get a Safe Space to Air Touchy Issues of Identity By feedproxy.google.com Published On :: Tue, 03 Mar 2020 00:00:00 +0000 Affinity groups known as caucuses let teacher-candidates at the University of Washington gather with others who share part of their identity, such as race, ethnicity, gender, or sexual orientation. Full Article Diversity
safe Fewer Fights and Increased Security: What New Data Say About School Safety By blogs.edweek.org Published On :: Wed, 17 Apr 2019 00:00:00 +0000 Amid public concerns about school safety fueled by high-profile school shootings, new federal data show reports of student fights, bullying, and other forms of victimization have continued a decades-long trend of decline. At the same time, schools have ramped up security measures, like the use of ca Full Article Bullying
safe A Statewide Trial of the SafeCare Home-based Services Model With Parents in Child Protective Services By pediatrics.aappublications.org Published On :: 2012-02-20T00:08:23-08:00 Neglect cases in Child Protective Services often receive home-based interventions, but their success in preventing maltreatment recidivism has been elusive. Structured, behavioral skills models, such as SafeCare, are promising but have not been tested in full-scale implementation trials.This cluster trial experiment demonstrates significant maltreatment recidivism reduction due to implementing the SafeCare model in a fully scaled-up statewide system. The findings support adopting the SafeCare model for these types of services. (Read the full article) Full Article
safe Erythropoietin for Neuroprotection in Neonatal Encephalopathy: Safety and Pharmacokinetics By pediatrics.aappublications.org Published On :: 2012-09-24T00:07:05-07:00 Infants with hypoxic-ischemic encephalopathy suffer a high rate (>40%) of death or moderate to severe disability, even after therapeutic hypothermia. High-dose erythropoietin (Epo) reduces brain injury and improves neurologic function in animal models of neonatal hypoxic-ischemic brain injury.Multiple doses of Epo (up to 2500 U/kg intravenously) given in conjunction with hypothermia are well tolerated in newborns with HIE. Epo doses of 1000 U/kg intravenously in cooled infants produce plasma concentrations that are neuroprotective in animal studies. (Read the full article) Full Article
safe Home Safety and Low-Income Urban Housing Quality By pediatrics.aappublications.org Published On :: 2012-11-12T00:08:24-08:00 The effect of substandard housing on children’s risk of diseases such as asthma has been studied; little is known about how it affects child injury risk. Pediatricians actively promote injury prevention but typically without regard to housing quality.Low-income children are likely living in substandard homes, which is significantly associated with not having working smoke alarms and safe hot water temperatures. Pediatricians can use these results to inform anticipatory guidance. (Read the full article) Full Article
safe Differences in Quality of Care Among Non-Safety-Net, Safety-Net, and Children's Hospitals By pediatrics.aappublications.org Published On :: 2013-01-06T23:57:25-08:00 Previous studies suggest that hospitals under the greatest financial strain may be more prone to adverse events because they have limited resources to invest in quality and safety.The patient population served, rather than hospital category, best predicts measured quality, underscoring the need for robust risk adjustment when incentivizing quality or comparing hospitals. Thus, problems of quality may not be systemic across hospital categories. (Read the full article) Full Article
safe Effectiveness of a Safe Routes to School Program in Preventing School-Aged Pedestrian Injury By pediatrics.aappublications.org Published On :: 2013-01-14T00:07:20-08:00 A number of studies have demonstrated community acceptance of Safe Routes to School interventions as well as their success in addressing perceptions about safety, but little is known about their effectiveness in reducing pedestrian injury risk in school-aged children.Implementation of a Safe Routes to School program in New York City may have contributed to a substantial reduction in school-aged pedestrian injury rates, with the effects largely limited to school-travel hours in census tracts with these interventions. (Read the full article) Full Article
safe Playground Safety and Quality in Chicago By pediatrics.aappublications.org Published On :: 2013-01-21T00:07:00-08:00 Quality urban playgrounds that are accessible and safe support physical activity and decrease injury rates. Little is known about the quality and accessibility of playgrounds in Chicago public parks.Most playgrounds in Chicago are in fair condition, yet access to quality playgrounds varies by neighborhood. Public/private collaboration can lead to improved playgrounds, and failing playgrounds can be improved with modest investment. (Read the full article) Full Article
safe Safety and Utilization of Influenza Immunization in Children With Inflammatory Bowel Disease By pediatrics.aappublications.org Published On :: 2013-05-06T00:07:29-07:00 Yearly influenza immunization is recommended in patients with inflammatory bowel disease (IBD). However, concern regarding vaccine-related adverse events may limit uptake, and case reports in the literature detail disease flares after immunization.Influenza immunization rates in children with IBD are low but immunization did not result in increased outpatient visits, hospitalizations or emergency visits. Immunization was associated with fewer IBD-related visits in the post-vaccine period, which may indicate protection against IBD symptoms. (Read the full article) Full Article
safe Randomized Controlled Trial of a Car Safety Seat Insert to Reduce Hypoxia in Term Infants By pediatrics.aappublications.org Published On :: 2013-07-15T00:07:09-07:00 Brief periods of low oxygen saturation are common in infants while restrained in car safety seats. There is some evidence that an insert that allows the infant head to rest in a neutral position in sleep may reduce hypoxic episodes.This randomized controlled study shows that the insert reduced numbers of obstructive apneas and the severity of desaturation events but did not significantly reduce the overall rate of moderate desaturations. (Read the full article) Full Article
safe Safety of Medical Interventions in Children Versus Adults By pediatrics.aappublications.org Published On :: 2014-02-24T00:07:04-08:00 Drug use in pediatrics is often based on adult efficacy data. Clinically significant discrepancies between adults and children may exist. To our knowledge, there is no large-scale evaluation of evidence comparing rates of adverse events between adults and children.Available evidence on the comparative safety of pharmacologic interventions in adults versus children is inconclusive. In a third of meta-analyses, twofold or greater differences were identified between adults and children, and some clinically important discrepancies were also found. (Read the full article) Full Article
safe Live Vaccine Use and Safety in DiGeorge Syndrome By pediatrics.aappublications.org Published On :: 2014-03-31T00:06:58-07:00 Individuals with DiGeorge syndrome (DGS) have varying degrees of immunodeficiency. All are susceptible to vaccine-preventable infections with serious complications. Although live vaccines are generally contraindicated in this population, limited evidence suggests that they may be effective and safe for select individuals.Many individuals with DGS received live vaccines despite having a known diagnosis. Adverse events following live immunizations were typically minor and self-limited, suggesting that live vaccines may be considered for patients with DGS who exhibit mild-to-moderate immunosuppression. (Read the full article) Full Article
safe Safety of Rotavirus Vaccine in the NICU By pediatrics.aappublications.org Published On :: 2014-05-19T00:07:01-07:00 Rotavirus vaccination is discouraged during hospitalization, given concerns regarding live-attenuated virus transmission; vaccination is recommended upon NICU discharge for eligible infants, however. Vaccination must be initiated before 104 days of age or infants become age-ineligible.RotaTeq vaccine administered with routine 2-month vaccinations within the NICU was tolerated in recipients, with no suggestion of symptomatic nosocomial transmission to neighboring unvaccinated infants. (Read the full article) Full Article
safe Safety and Efficacy of Filtered Sunlight in Treatment of Jaundice in African Neonates By pediatrics.aappublications.org Published On :: 2014-05-26T00:07:47-07:00 Phototherapy effectively treats unconjugated hyperbilirubinemia. However, in resource-poor settings, functional phototherapy devices are often unavailable due to financial constraints or erratic electrical power availability.Filtered-sunlight phototherapy could be a cost-effective option in resource-poor settings with abundant sunlight. (Read the full article) Full Article
safe Safety of Live-Attenuated Influenza Vaccination in Cystic Fibrosis By pediatrics.aappublications.org Published On :: 2014-09-15T00:06:28-07:00 Influenza leads to respiratory deteriorations in cystic fibrosis (CF) patients. In children, live attenuated influenza virus vaccine (LAIV) is more efficacious than inactivated influenza vaccines, which could be beneficial for CF. Data on the safety of LAIV in this population are scarce.This study assesses LAIV’s safety in patients with CF and is necessary to determine whether the anticipated benefits associated with LAIV will outweigh potential risks. This can potentially lead to a recommendation for preferential LAIV use in this population. (Read the full article) Full Article
safe Safety and Effectiveness of Continuous Aerosolized Albuterol in the Non-Intensive Care Setting By pediatrics.aappublications.org Published On :: 2014-09-29T00:06:47-07:00 Continuously aerosolized albuterol been shown to be safe and effective for the treatment of severe status asthmaticus in the emergency department and ICU. Little evidence supports its use in the non–intensive care setting.With the appropriate resources and support, continuous albuterol may be administered in the non–ICU setting with a low incidence of clinical deterioration and adverse effects. Certain clinical factors may help identify which patients may benefit from higher acuity care. (Read the full article) Full Article
safe Safety of Measles-Containing Vaccines in 1-Year-Old Children By pediatrics.aappublications.org Published On :: 2015-01-05T00:06:54-08:00 Measles-containing vaccines are associated with several types of adverse events. Because measles-mumps-rubella-varicella (MMRV) versus separate measles-mumps-rubella (MMR) and varicella (MMR + V) vaccine increases a toddler’s risk for febrile seizures, we investigated whether MMRV is riskier than MMR + V and whether either vaccine elevates risk for additional safety outcomes.Comparing MMRV with MMR + V, no increased risk of immune thrombocytopenia purpura, anaphylaxis, ataxia, arthritis, meningitis/encephalitis, acute disseminated encephalomyelitis, and Kawasaki disease was detected. No new safety concerns were identified after either vaccine, and most outcomes studied were unlikely after either vaccine. (Read the full article) Full Article
safe Safety and Efficacy of Pimecrolimus in Atopic Dermatitis: A 5-Year Randomized Trial By pediatrics.aappublications.org Published On :: 2015-03-23T00:05:26-07:00 Topical corticosteroids are often used to treat atopic dermatitis (AD) in infants, although compliance is poor due to concerns over side effects. Pimecrolimus was shown to be a safe and effective noncorticosteroid treatment of AD in infants in short-term studies.The Petite Study shows that long-term management of mild-to-moderate AD in infants with pimecrolimus or topical corticosteroids was safe without any effect on the developing immune system. Pimecrolimus had similar efficacy to topical corticosteroids and a marked steroid-sparing effect. (Read the full article) Full Article
safe Safety Incidents in the Primary Care Office Setting By pediatrics.aappublications.org Published On :: 2015-05-04T00:05:18-07:00 More than a quarter of child deaths in the United Kingdom are estimated to have identifiable failures in care. Although children account for 40% of the family practice workload, little is known about iatrogenic harm to children in this setting.This is the first analysis of nationally collected pediatric safety incident reports from family practice. To mitigate harm to children, priority areas requiring improvement include medication provision, referral of unwell children, provision of evidence-based treatment, and adequate diagnosis and assessment. (Read the full article) Full Article
safe Immunogenicity and Safety of a 9-Valent HPV Vaccine By pediatrics.aappublications.org Published On :: 2015-06-22T00:06:54-07:00 Prophylactic vaccination of young women 16 to 26 years of age with the 9-valent human papillomavirus (HPV)–like particle (9vHPV) vaccine prevents infection and disease with vaccine HPV types.These data support bridging the efficacy findings with 9vHPV vaccine in young women 16 to 26 years of age to girls and boys 9 to 15 years of age and implementation of gender-neutral HPV vaccination programs in preadolescents and adolescents. (Read the full article) Full Article
safe Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants By pediatrics.aappublications.org Published On :: 2015-07-27T00:08:20-07:00 The routine childhood immunization schedule is crowded during the first 2 years, leading to deferred doses and limiting the addition of new vaccines. Combination vaccines can reduce the "shot burden" and improve coverage rates and timeliness.Antibody response rates to antigens contained in an investigational hexavalent vaccine (DTaP5-IPV-Hib-HepB) were noninferior to licensed comparator vaccines when given as a 3-dose infant series. The safety profile was similar to control except for increased rates of mild-to-moderate, self-limited fever. (Read the full article) Full Article
safe Safety of Botulinum Toxin Type A for Children With Nonambulatory Cerebral Palsy By pediatrics.aappublications.org Published On :: 2015-10-19T00:07:49-07:00 Children with marked cerebral palsy (CP) are considered at greater risk of adverse events (AEs) after intramuscular injections of BoNT-A. To date there has been no randomized controlled trial examining safety of intramuscular BoNT-A injections in children with marked CP.Children with nonambulatory CP had no greater risk of moderate or serious AEs after intramuscular injections of BoNT-A compared with a sham/control group. There was no greater risk of AEs for children receiving 2 compared with 1 episode of BoNT-A. (Read the full article) Full Article
safe Promoting HPV Vaccination in Safety-Net Clinics: A Randomized Trial By pediatrics.aappublications.org Published On :: 2015-10-19T00:07:48-07:00 Previous studies have evaluated separately the effects of brief education and reminder/recall intervention strategies to increase human papillomavirus vaccine coverage. None have examined if intervention effects varied by race/ethnicity.When compared with a general adolescent vaccine brochure, human papillomavirus vaccine-specific educational materials increased 1-dose coverage among Hispanic but not black individuals. Recalls for doses 2 and 3 were effective in increasing 3-dose coverage for both racial/ethnic groups. (Read the full article) Full Article
safe What's the safest way to pay for things? | Ask CIDD By news.psu.edu Published On :: Wed, 29 Apr 2020 14:07 -0400 Full Article
safe Superintendent: Immigrant Students Need a Safe Harbor in School By feedproxy.google.com Published On :: Mon, 19 Aug 2019 00:00:00 +0000 In the wake of anti-immigrant violence, we must help make sure that all students feel welcomed, writes Susana Cordova. Full Article Immigrants
safe Safety, Pharmacokinetics, and Drug:Drug Interaction Potential of Intravenous Durlobactam, a {beta}-lactamase Inhibitor, in Healthy Subjects [Pharmacology] By aac.asm.org Published On :: 2020-04-13T08:15:30-07:00 Durlobactam (DUR, also known as ETX2514) is a novel β-lactamase inhibitor with broad activity against Ambler class A, C, and D β-lactamases. Addition of DUR to sulbactam (SUL) in vitro restores SUL activity against clinical isolates of Acinetobacter baumannii. The safety and pharmacokinetics (PK) of DUR alone and with SUL and/or imipenem/cilastatin (IMI/CIL) were evaluated in healthy subjects. This was a randomized, placebo-controlled study. In Part A, subjects including an elderly cohort (DUR 1 g) received single ascending doses of DUR 0.25-8 g. In Part B, multiple ascending dose of DUR 0.25-2 g were administered every 6 hours (q6h) for 29 doses. In Parts C and D, the drug-drug interaction (DDI) potential, including safety, of DUR (1 g) with SUL (1 g) and/or IMI/CIL (0.5/0.5 g) was investigated after single and multiple doses. Plasma and urine concentrations of DUR, SUL, and IMI/CIL were determined. Among 124 subjects, DUR was generally safe and well tolerated either alone or in combination with SUL and/or IMI/CIL. After single and multiple doses, DUR demonstrated linear dose proportional exposure across the studied dose ranges. Renal excretion was a predominant clearance mechanism. No drug:drug interaction potential was identified between DUR and SUL and/or IMI/CIL. SUL-DUR, 1 g (of each component) administered q6h with a 3 hour IV infusion, is under development for the treatment of serious infections due to A. baumannii. Full Article
safe Phase 2a Pharmacokinetic, Safety, and Exploratory Efficacy Evaluation of Oral Gepotidacin (GSK2140944) in Female Participants With Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis) [Clinical Therapeutics] By aac.asm.org Published On :: 2020-04-13T08:15:31-07:00 Gepotidacin, a triazaacenaphthylene bacterial type II topoisomerase inhibitor, is in development for treatment of uncomplicated urinary tract infection (uUTI). This Phase 2a study in female participants with uUTI evaluated the pharmacokinetics (primary objective), safety, and exploratory efficacy of gepotidacin. Eligible participants (N = 22) were confined to the clinic at baseline, received oral gepotidacin 1,500 mg twice daily for 5 days (on-therapy; Days 1 to 5), and returned to the clinic for test-of-cure (Days 10 to 13) and follow-up (Day 28±3). Pharmacokinetic, safety, clinical, and microbiological assessments were performed. Maximum plasma concentrations were observed approximately 1.5 to 2 hours postdose. Steady state was attained by Day 3. Urinary exposure over the dosing interval increased from 3,742 μg.h/ml (Day 1) to 5,973 μg.h/ml (Day 4), with trough concentrations of 322 to 352 μg/ml from Day 3 onward. Gepotidacin had an acceptable safety-risk profile with no treatment-limiting adverse events and no clinically relevant safety trends. Clinical success was achieved in 19 (86%) and 18 (82%) of 22 participants at test-of-cure and follow-up, respectively. Eight participants had a qualifying baseline uropathogen (growth; ≥105 CFU/ml). A therapeutic (combined clinical and microbiological [no growth; <103 CFU/ml]) successful response was achieved in 6 (75%) and 5 (63%) of 8 participants at test-of-cure and follow-up, respectively. Plasma area under the free-drug concentration-time curve over 24 hours at steady state divided by the MIC (fAUC0-24/MIC) and urine AUC0-24/MIC ranged from 6.99 to 90.5 and 1,292 to 121,698, respectively. Further evaluation of gepotidacin in uUTI is warranted. (NCT03568942) Full Article
safe Safety and tolerability of more than 6 days of tedizolid treatment [Clinical Therapeutics] By aac.asm.org Published On :: 2020-04-20T08:36:46-07:00 Tedizolid has demonstrated its efficacy and safety in clinical trials, however, data concerning its tolerability in long-term treatments is scarce. The aim of the study was to assess the indications and to describe the long-term safety profile of tedizolid.A multicentric, retrospective study of patients who received tedizolid for more than 6-days was conducted. Adverse events (AEs) were identified from patients' medical records and laboratory data. The World Health Organization causality categories were used to discern AEs probably associated with tedizolid.Eighty-one patients, treated with tedizolid 200mg once-daily for a median (IQR) duration of 28 (14-59) days, were included, 36 (44.4%) had previously received linezolid. Most common reasons for selecting tedizolid were to avoid linezolid potential toxicities or interactions (53.1%) or due to previous linezolid-related toxicities (27.2%). Most common indications were off-label, including prosthetic joint infections, osteomyelitis and respiratory infections (77.8%). Overall, 9/81 patients (11.1%) experienced a probably associated AE. Two patients (2.5%) developed gastrointestinal disorders, 1 (1.2%) anemia and 6 thrombocytopenia (7.4%) after a median (IQR) duration of treatment of 26.5 (17-58.5) days. Four (5%) patients discontinued tedizolid due to AEs. Among 23 patients with chronic renal failure (CRF) the rate of mielotoxicity was 17.4% and only 8.7% had to stop tedizolid and 20 out of 22 with previous linezolid-associated toxicity had no AE.Long-term tedizolid treatments had good tolerance with rates of gastrointestinal AE and hematological toxicity lower than those reported with linezolid, particularly in patients with CRF and in those with a previous history of linezolid-associated toxicity. Full Article
safe Cardiovascular safety and population pharmacokinetic properties of piperaquine in African patients with uncomplicated falciparum malaria - a pooled multicentre analysis [Clinical Therapeutics] By aac.asm.org Published On :: 2020-04-20T08:36:47-07:00 Dihydroartemisinin-piperaquine has shown excellent efficacy and tolerability in malaria treatment. However, concerns have been raised of potentially harmful cardiotoxic effects associated with piperaquine. The population pharmacokinetics and cardiac effects of piperaquine were evaluated in 1,000 patients, mostly children enrolled in a multicentre trial from 10 sites in Africa. A linear relationship described the QTc-prolonging effect of piperaquine, estimating a 5.90ms mean QTc-prolongation per 100ng/mL increase in piperaquine concentration. The effect of piperaquine on absolute QTc-interval estimated a mean maximum QTc-interval of 456ms (EC50=209ng/mL). Simulations from the pharmacokinetic-pharmacodynamic models predicted 1.98-2.46% risk of having QTc-prolongation > 60ms in all treatment settings. Although piperaquine administration resulted in QTc-prolongation, no cardiovascular adverse events were found in these patients. Thus, the use of dihydroartemisinin-piperaquine should not be limited by this concern. Full Article
safe Fin24.com | What to know about shift from equities to 'safety' of bonds By www.fin24.com Published On :: Thu, 12 Dec 2019 13:37:35 +0200 Geopolitical factors and economic uncertainty make some investors shift away from equities into what they perceive to be the safety of higher-quality bonds. Full Article