US Candida auris case count tops 600Confirmed and probable Candida auris cases in the United States through Mar 31 rose to 643, an increase of 56 from the end of February, the Centers for Disease Control and Prevention (CDC) said in an update yesterday.Illnesses caused by the multidrug-resistant fungus have been reported in 12 states, though 95% are in New York (323), Illinois (160), and New Jersey (128). The other states reporting cases are California (2), Connecticut (1), Florida (13), Indiana (1), Maryland (3), Massachusetts (7), Oklahoma (2), Texas (2), and Virginia (1).Of the 643 cases, 613 are confirmed and 30 are listed as probable. Screening for C auris has found an additional 1,123 patients who are colonized. The number of colonized patients has grown by 67 since the CDC’s last update. The screening is part of the CDC’s efforts to control the spread of the fungus, which is known to persist on surfaces in healthcare facilities and spread among patients.Since its first identification in 2009 in Japan, C auris has triggered outbreaks in healthcare facilities in more than 20 countries and has shown resistance to three major antifungal drug classes. C auris can cause serious invasive infections in patients who have compromised immune systems, and the CDC has estimated that 30% to 60% of patients with infections have died.Apr 30 CDC C auris case count FDA turns down new antibiotic candidate over manufacturing concernsCiting concerns about manufacturing standards, the US Food and Drug Administration (FDA) has rejected Nabriva Therapeutics’ New Drug Application (NDA) for Contepo (fosfomycin for injection) for complicated urinary tract infections (cUTIs), including pyelonephritis.Dublin-based Nabriva announced yesterday that the FDA has asked the company to address issues related to facility inspections and manufacturing deficiencies at one of its contract manufacturers before approving the NDA, but did not request any new clinical data or raise safety concerns about the drug. Nabriva said it plans to request a “Type A” meeting to discuss the FDA’s findings.”We need to meet with the FDA to get a better understanding of the issues identified during the facility inspection, what concerns remain based on the responses submitted during the expedited 4-month review process, and whether or not the manufacturer’s corrective actions sufficiently addressed them,” Nabriva CEO Ted Schroeder said today during a company conference call.Contepo is an investigational, intravenous formulation of fosfomycin that has been used outside the United States for cUTIs and other infections for 45 years. Currently, only oral fosmfomycin is FDA-approved for treating cUTIs. Nabriva believes Contepo could be a first-in-class treatment because it has activity against gram-positive and gram-negative pathogens, including multidrug-resistant (MDR) strains, and it uses a new dosing approach that optimizes the compound’s pharmacokinetics and pharmacodynamics.The FDA previously granted Contepo Qualified Infectious Disease Product and Fast Track designations for cUTIs, complicated intra-abdominal infections, hospital-acquired and ventilator-associated bacterial pneumonia, and acute bacterial skin and skin-structure infections.Apr 30 Nabriva press release Study suggests shorter empiric antibiotic course for neonatal sepsisA study today in the Pediatric Infectious Disease Journal suggests that empiric antibiotics with gram-negative coverage for infants who have suspected early-onset sepsis (EOS) can be safely stopped after 24 hours.The retrospective analysis of blood samples collected from the neonatal intensive care unit at McMaster Children’s Hospital in Ontario over a 10-year period included 7,480 blood cultures (from 9,245 neonates) that were sent to the microbiology laboratory for evaluation of sepsis.The investigators used BacT/Alert 3D, an automated microbial detection system that can identify positive blood samples faster than traditional blood culture methods. The aim was to analyze the time taken to detect positive blood cultures and determine whether empiric antibiotics could be discontinued by 24 or 36 hours to rule out sepsis. Generally, clinicians wait 48 hours before deciding to discontinue antibiotics, but concerns about inappropriate antibiotic use have prompted re-evaluation of this practice.Of the 7,480 blood cultures performed, 885 grew microorganisms, and 845 culture reports from 627 neonates were analyzed. Definite or opportunistic pathogens caused 815 infections (96%), and the rest were contaminants. EOS accounted for 54 of the positive cultures, and late-onset sepsis (LOS) for 791. Gram-negative organisms grew faster than gram-positive organisms, with 99% of gram-negatives having detectable growth by 24 hours, compared with 67.2% of gram-positives. Cultures from EOS were positive significantly earlier than LOS. After adjusting for covariates, gram-negative status was an independent predictor of early detection of a positive blood culture (hazard ratio, 3.5; 95% confidence interval [CI], 2.7 to 4.5).”This suggests that empiric antibiotics with Gram-negative coverage can be safely stopped if the 24-hour BacT/Alert is reported negative, provided there are no clinical or laboratory parameters suggesting sepsis,” the authors of the study write. “Empirical Gram-positive coverage can be stopped between 48 and 72 hours, particularly if there is no setting for an opportunistic infection, such as prematurity, immunodeficiency or indwelling catheters.”May 1 Pediatr Infect Dis J study Longer surgical prophylaxis linked to higher risk of adverse eventsA national cohort study of patients in the Veterans Administration (VA) healthcare system has found that increasing the duration of surgical antibiotic prophylaxis was not associated with additional reductions in surgical-site infection (SSI), but it was associated with increases in adverse events in a dose-dependent fashion. The findings appeared in JAMA Surgery.In the study, a team led by researchers with the VA Boston Healthcare System analyzed data on 79,058 patients who underwent cardiac, total joint replacement, colorectal, and vascular procedures in the VA healthcare system from October 2008 through September 2013. The outcomes of interest were 30-day SSI, 7-day incidence of acute kidney injury (AKI), and 90-day incidence of Clostridioides difficile infection. The exposure variables of interest were duration and type of surgical prophylaxis.After adjusting for SSI risk factors, the researchers found that antibiotic courses lasting more than 24 hours did not lead to reductions in SSI among any of the types of surgery evaluated. But adjusted odds of AKI increased with each additional day of prophylaxis, rising by 3.2% in cardiac procedures after 24 to less than 48 hours (adjusted odds ratio [aOR], 1.03; 95% CI, 0.95 to 1.12), by 22.3% after 48 to less than 72 hours (aOR, 1.22; 95% CI, 1.08 to 1.39), and by 82.0% after 72 hours or more (aOR, 1.82; 95% CI, 1.54 to 2.16). A similar increase in AKI risk was observed for non-cardiac procedures.Odds of C difficile infection for all procedures increased nonsignificantly by 7.8% after 24 to less than 48 hours of antimicrobial prophylaxis (aOR, 1.08; 95% CI, 0.89 to 1.31) and significantly increased by 142.6% after 48 to less than 72 hours (aOR, 2.43; 95% CI, 1.80 to 3.27) and by 265.1% after 72 hours or more (aOR, 3.65; 95% CI, 2.40 to 5.55).The analysis also found that use of vancomycin was a significant risk factor for AKI in cardiac procedures (aOR, 1.17; 95% CI, 1.10 to 1.25) and noncardiac procedures (aOR, 1.21; 95% CI, 1.13 to 1.30). The authors conclude, “These data should be used to inform policy surrounding surgical prophylaxis and may have broader implications for antimicrobial stewardship programs aiming to reduce harms associated with unnecessary antimicrobial exposures. Every day—and every dose—matters.”Apr 24 JAMA Surg study
The U.S Army Corps of Engineers, Seattle District, has partnered with the Seattle Parks and Recreation to design and implement a coastal storm damage reduction project under Section 103 of the Rivers and Harbors Act of 1962, as amended. The public comment period for this project runs through December 31. Emma Schmitz Overlook is located at 4503 Beach Drive SW, south of Alki Point in Seattle. The site includes a seawall built around 1927 that has deteriorated over time. Currently coastal storms and erosion threaten public infrastructure located in and around the seawall, including a 54-inch King County sewer main, a major public arterial, city park property and other underground utilities.The recommended plan includes construction of a soldier pile seawall parallel to the shoreline throughout the study area. The new seawall would be a few feet higher and seaward of the existing seawall. This would provide protection against damages caused by coastal storm events that occur in Puget Sound.In 1998, the City of Seattle was prompted to take emergency action to stabilize the shoreline to the north of the proposed federal project when storm waves resulted in the failure of a similar section of existing seawall and subsequent erosion of shoreline protection that threatened utilities, roadways, and public lands. The city completed permanent emergency repairs on this adjacent site, which is not included in the scope of the proposed Federal project.The recommended plan was chosen because it has the least environmental impacts, cost the least cost and meets all project purposes. Coordination with resource agencies and federal tribes is ongoing and preliminary indications expect a concurrence with the project.The implementation cost of the recommended plan is estimated to be $2.29 million and will be cost-shared 65 percent federal ($1,488,000) and 35 percent non-federal ($801,000). The non-federal sponsor, Seattle Parks and Recreation, is responsible for all lands, easements, right-of-ways, relocations, and/or disposal areas which are controlled by the sponsor.Economic analysis suggests the project could prevent millions of dollars of physical and non-physical damages, resulting in a favorable benefit-cost ratio.[mappress mapid=”19589″]Press Release
Keith Urban to release new album The Speed of Now Part 1 in SeptemberKeith Urban to release new album The Speed of Now Part 1 in September
Keith Urban will release new album The Speed of Now Part 1 on 18th September 2020.The album is the follow-up to his 2018 album Graffiti U and it’s expected to feature the recent singles God Whispered Your Name and Polaroid. Keith revealed the news in a video, which you can see below:Talking about the record Keith said, “In October 2019 this album title came to me. I liked it because I felt like life was flying by so fast. But music (for me) has always been the place where it slows down and doesn’t even exist. I would never have imagined that, in 2020, this album title would take on a whole new meaning.”More details on the album are expected in the coming week but we can guess that Keith will continue to experiment with his sound like he’s done on his past few records. Since 2016’s Ripcord Keith has been pushing the boundaries of Country music moving further into pop and even R&B.Keith was due to be in the UK for a headline tour this month but it’s been postponed to October due to the ongoing COVID-19 pandemic.
The 2020 Yamaha MT-03 has been launched for the US and UK markets.As it shares the 321cc parallel-Twin engine as the Yamaha YZF-R3, it would known as the MT-25 in our market since it’ll adopt the YZF-R25’s 250cc engine.Being a part of the MT-series the model shares the “Dark Side of Japan” DNA with its larger MT-07 and MT-09 siblings, such as the large faux air scoops. It features styling elements of the other two, plus an new and aggressive headlamp with striking LEDs.A new 14-litre tank should see a range of up to a 300 kilometre range. There is also a new LCD screen.But look a little closer and you can see a resemblance to YZF-R3 in terms of the tail section and frame.Indeed, while the diamond-shape frame is from the R3, the suspension features a number of differences. The forks are now upside-down, while the new swingarm is longer and pivots closer to the centre of the bike. The rear monoshock has a stiffer springs in addition to revised preload and rebound damping rates. The manufacturer sees the bike as a great offering to the younger segment of riders.The big question if the MT-25 will ever be sold in Malaysia. The MT-15 and MT-25 are already sold in Thailand and Indonesia to big success.–Ads– The 2020 Yamaha MT-03 has been launched for the US and UK markets. Will it and the MT-15 reach Malaysia? It shares the same DNA as the MT-07 and MT-09.