FDA clears rapid antibiotic susceptibility test

News brief

Boston-based biotech Selux Diagnostics announced today that the US Food and Drug Administration (FDA) has granted the company a 510(k) clearance for its rapid in vitro antibiotic susceptibility testing platform.

The FDA clearance means the company can now commercialize its Next Generation Phenotyping (NGP) System, which provides susceptibility results within 24 hours for 14 antimicrobial agents on the Selux Gram-positive panel. The FDA is also reviewing Selux's NGP Gram-negative panel.

Selux has received $60.8 million in funding from the Biomedical Advanced Research and Development Authority to support development of the NGP platform, which the company says provides susceptibility results days faster than the current standard of care, shortening the time to selection of targeted antimicrobial therapy for patients with bacterial infections.

This clearance represents a significant advance in infectious disease care and the fight to address antibiotic resistance.

"This clearance represents a significant advance in infectious disease care and the fight to address antibiotic resistance," Selux CEO Steve Lufkin, MBA, said in a company press release. "Our groundbreaking Selux NGP System holds the potential to save lives and decrease overreliance on broad-spectrum antibiotics, a key factor contributing to the rise of superbugs."

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First-wave COVID patients had much higher risk of death for 18 months

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In the first wave of the COVID-19 pandemic, infected UK patients had a significantly elevated risk of cardiovascular disease (CVD) for at least 18 months, suggests a study of nearly 160,000 people published today in Cardiovascular Research.

University of Hong Kong researchers followed 7,584 patients listed in the UK Biobank who tested positive for COVID-19 from Mar 16 to Nov 30, 2020, before vaccines were available, for up to 18 months. Their outcomes were compared with those of randomly matched, uninfected controls from two groups: a contemporary cohort from Mar 16 to Nov 30, 2020, and a historical cohort from the same period in 2018.

The average age in all three groups was 66 years, and the proportions of men and women were nearly equal.

As much as 81 times more likely to die

In the acute phase (first 21 days after diagnosis), compared with the 75,790 contemporary and 75,774 historical controls, COVID-19 was tied to four to five times the risk of CVD (hazard ratios [HRs], 4.3 and 5.0, respectively). In the same period, the risk of all-cause death was 81 times and nearly 68 times higher in COVID-19 patients (HRs, 81.1 and 67.5, respectively).

In the post-acute phase (up to 18 months), COVID-19 patients remained at a significantly higher risk of CVD (HRs, 1.4 and 1.3 relative to the 71,296 contemporary and 71,314 historical controls, respectively) and of all-cause death (HRs, 5.0 and 4.5, respectively). COVID-19 patients with severe disease were more likely to experience major CVD or die than those with milder illness.

"The findings indicate that patients with COVID-19 should be monitored for at least a year after recovering from the acute illness to diagnose cardiovascular complications of the infection, which form part of long COVID," senior author Ian C. K. Wong, PhD, said in a European Society of Cardiology press release.

Wong added that the historical control group was included to rule out the consequences of disrupted healthcare services after the pandemic began, which led to poorer health and higher death rates even in uninfected people.

Global mpox cases rise slightly, with more deaths reported

News brief

In its latest situation report on mpox today, the World Health Organization (WHO) said cases since its last update on Jan 5 have risen 1%, and, of 11 countries reporting increases, the largest was in Mexico.

Over the past 2 weeks, 790 new cases were reported, mostly from the Americas region, including 59 from Mexico. Of 110 countries that have reported cases, 78 have gone without a new case for 21 days, which is the maximum incubation period. The developments lifted the global mpox total to 84,773.

Four more deaths were reported, three in Peru and one in Chile, pushing the global fatality count to 80.

US deaths rise to 23

Meanwhile, other health groups also posted mpox updates. The US Centers for Disease Control and Prevention (CDC) yesterday reported 46 more cases over the past week, along with 2 more deaths, raising the nation's total to 30,026 cases, 23 of them fatal.

Demetre Daskalakis, MD, deputy coordinator of the CDC's mpox response, said on Twitter yesterday that the nation is averaging about two cases a day, with a goal of driving daily cases down to zero. He added that the vaccine mission isn't done, with first and second vaccine doses needed for those who haven't gotten them and can benefit from them.

Elsewhere, the European Centre for Disease Prevention and Control, in a joint surveillance update yesterday with the WHO European regional office, said over the past 4 weeks 166 more mpox cases have been reported from 14 European countries. More than half were reported by Spain, followed by Italy and Sweden.

Study: Prescribing guidelines based on low procalcitonin require high adherence to reduce antibiotics

News brief

High adherence to a procalcitonin antibiotic prescribing guideline in hospital settings is necessary to reduce antibiotic use in patients with suspected lower respiratory tract infections (LRTIs), according to a study published today in BMC Infectious Diseases.

For the study, researchers from the University of Pittsburgh conducted a retrospective analysis of data from the Procalcitonin Antibiotic Consensus Trial (ProACT), which randomized 1,656 patients with suspected LRTIs at 14 US hospitals to usual care or provision of procalcitonin assay results and an antibiotic prescribing guideline for the treating physician. ProACT found that providing clinicians with assay results for procalcitonin levels (which are typically elevated in bacterial infections and not in viral infections) and an antibiotic treating guideline did not reduce antibiotic use, as it had in several European trials.

The researchers suspected the ProACT results were because of low clinician adherence to the guidelines (64.8%) and wanted to see whether higher adherence might have made a difference. To evaluate the impact of adherence on the primary outcome of antibiotic-days by day 30, they varied adherence between 65% and 100% and determined which threshold adherence rate for low procalcitonin in the intervention arm could have allowed rejection of the null hypothesis (no difference between groups). They also determined the threshold rate for continued guideline adherence after discharge.

Analysis: 84% adherence required

The analysis found that an adherence rate of 84% in the hospital setting (emergency department and inpatient) for low procalcitonin in the intervention arm could have allowed rejection of the null hypothesis (3.7 vs 4.3 antibiotic-days). Complete guideline adherence (100%) in the hospital would have resulted in 0.9 fewer antibiotic-days. The threshold adherence rate for continued guideline adherence after discharge was 76%. 

The researchers also noted that, of the 218 patients in the intervention arm who were prescribed antibiotics in the emergency department despite low procalcitonin, 153 (70.2%) were categorized as low or medium risk—a group they suggest might be more willing to forego antibiotics.

"Continued guideline adherence after discharge and withholding of antibiotics in low and medium risk patients with low procalcitonin may offer impactful potential opportunities for antibiotic reduction," they wrote.

 

Virginia county reports first CWD case; Louisiana finds more

News brief

The Virginia Department of Wildlife Resources (DWR) has reported the first case of chronic wasting disease (CWD) in Fairfax County, and the Louisiana Department of Wildlife and Fisheries (LDWF) has identified five more suspected cases in Tensas Parish.

In a press release issued earlier this week, the Virginia DWR reported that a hunter-harvested adult male deer tested positive for CWD. As part of its surveillance program, the DWR tested a sample from the buck after the hunter took it to a taxidermist in late October 2022. "At the time of harvest, no outward signs of disease were noted, and the deer appeared to be in good condition," the release said.

From 2009 to 2022, Virginia reported 134 CWD cases. CWD, a fatal prion disease that affects cervids such as deer, elk, and moose, has been found in 30 US states, four Canadian provinces, northern Europe, and South Korea.

Total in Tensas Parish, Louisiana, rises to 7

Louisiana has added another five suspected CWD cases in deer to the two previously reported in Tensas Parish, according to an LDWF press release.

Samples from the three does and two bucks, which were hunted on private land, are being tested at the National Veterinary Services Laboratory in Ames, Iowa. The two previous cases were reported in 2022.

While there is no evidence of CWD transmission to humans, experts remained concerned about a potential interspecies jump. As a result, both the US Centers for Disease Control and Prevention and the World Health Organization advise against consuming venison from infected deer. People who hunt in areas with previous CWD cases should have their deer tested for the disease before eating the meat, the release said.

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