News Scan for Jun 11, 2021

News brief

CDC-led study finds major racial disparities in MIS-C incidence

A surveillance study of US children during the first wave of the pandemic found that multisystem inflammatory syndrome in children (MIS-C) was a rare complication associated with SARS-CoV-2 infection, but incidence was significantly higher in non-White racial and ethnic groups, US researchers reported yesterday in JAMA Network Open.

Using enhanced surveillance data collected from seven states (Connecticut, Georgia, Massachusetts, Michigan, New Jersey, New York, and Pennsylvania) from April through June 2020, a team led by researchers from the Centers for Disease Control and Prevention (CDC) COVID-19 Response Team found that 248 people under age 21 with MIS-C were reported, with the most in New Jersey. The median age range at onset was 8, and 53.6% of the cases were male.

Overall incidence of MIS-C during the study period was 5.1 persons per 1,000,000 person-months. Compared with White persons, incidence was about ninefold higher among Black persons (adjusted incidence rate ratio [aIRR], 9.26; 95% confidence interval [CI], 6.15 to 13.93) and Hispanic or Latino persons (aIRR, 8.92; 95% CI, 6.0 to 13.26), and nearly threefold higher among Asian of Pacific Islanders (aIRR, 2.94; 95% CI, 1.49 to 5.92).

MIS-C incidence was 316 per 1,000,000 SARS-CoV-2 infections and was also higher among Black (aIRR, 5.62; 95% CI, 3.68 to 8.60), Hispanic or Latino (aIRR, 4.26; 95% CI, 2.85 to 6.38), and Asian or Pacific Islander persons (aIRR, 2.88; 95% CI, 1.42 to 5.38) compared with White persons. For both analyses, incidence was highest among children aged 5 years or younger and children aged 6 to 10 years.

"Our findings of higher incidence among younger children and among Hispanic or Latino, Black, and Asian or Pacific Islander persons emphasize a need for further study of risk factors for MIS-C," the study authors wrote.
Jun 10 JAMA Netw Open study

 

Most severe COVID patient autopsies showed muscle inflammation

In autopsies of 43 hospitalized COVID patients and 11 patients hospitalized for other health issues in Germany, those with COVID-19 were associated with more skeletal muscle inflammation, according to a study today in JAMA Neurology.

The researchers looked at cryopreserved quadriceps, deltoids, lungs, and heart tissues in people who died from March 2020 to February 2021. Of those who had COVID-19, the median age was 72, 72.1% were men, and COVID-19 infection was the primary cause of death in 83.7%. Those without COVID infection had a median age of 71, and 63.6% were men. All but one in the COVID-19 group had at least one concurrent medical issue, but none had a history of primary myopathy, or disease affecting muscle tissue.

Overall, 60.4% of COVID-19 patients had some sort of muscle inflammation, with more severe inflammation associated with those who were chronically ill with COVID-19 (30 or more days post-symptom onset) and then seroconverted. Patients with COVID-19 had skeletal muscles with higher overall pathology scores (average, 3.4 vs 1.5) and inflammation scores (average, 3.5 vs 1.0) compared with those without, and their natural killer cell levels were higher (median, 8 vs 3 per 10 high-power fields).

While SARS-CoV-2 RNA was found in some muscles of COVID-19 patients, the researchers say there was no evidence for direct viral infection and that its presence is most likely explained by circulating viral RNA.

"Most individuals with severe COVID-19 showed signs of myositis ranging from mild to severe. Inflammation of skeletal muscles was associated with the duration of illness and was more pronounced than cardiac inflammation," write the researchers. "This suggests that SARS-CoV-2 may be associated with a postinfectious, immune-mediated myopathy."
Jun 11 JAMA Neurol study

 

Two monkeypox cases confirmed in United Kingdom

Two monkeypox patients were identified in the United Kingdom at the end of May, one traveling from Nigeria and the other who was quarantining with the first patient upon arrival, the World Health Organization (WHO) said today. The WHO adds that the public health risk for monkeypox in the United Kingdom is low.

The index patient arrived in the United Kingdom on May 8 prior to living and working in Delta state, Nigeria. After arrival, the person quarantined because of COVID-19 protocols and developed a facial rash beginning on May 10.

The patient continued to quarantine for another 10 days and then looked for medical care on May 23 and received a confirmed diagnosis of West African clade monkeypox virus on May 25. One family member who was in quarantine with the index patient developed a similar rash May 29 and had confirmatory lab results on May 31. Both are stable and recovering, the WHO reports.

Contact tracing spanning 21 days after the patients' last exposure found that no close contact had traveled outside of the United Kingdom, and officials alerted Nigerian health officials. Post-exposure vaccination was not offered to the patients.

Monkeypox is transmitted by contact and droplet exposure. Incubation usually lasts 6 to 13 days, and the infection is often self-limiting, resolving within 14 to 21 days. The WHO says the disease is endemic in parts of West and Central Africa (eg, Democratic Republic of the Congo's October 2020 outbreak).

The WHO says the new cases raise the UK total to six, including three imported from Nigeria in 2018 and 2019. 
Jun 11 WHO news release

 

WHO weighs in on China's recent H10N3 avian flu case

The WHO yesterday shared more details about China's recent H10N3 avian flu case, the first known illness of its kind in a human. Earlier this month, China had reported the illness, which involves a 41-year-old man.

In a statement, the WHO said the man is from the city of Zhenjiang in Jiangsu province on China's east-central coast. His symptoms—nausea and fever—began on Apr 23. He was admitted to an intensive care unit on Apr 28, and he is currently listed in stable condition.

An investigation found no clear history of exposure to poultry, and no H10N3 had been detected in local poultry. No related infections were found in any of the man's contacts. Genetic analysis found that the virus is avian in origin. Further genetic analysis is under way to assess if the virus that infected the man is closely related to earlier avian H10N3 viruses.

Chinese officials consider that the case represents incidental transmission from birds to humans.

The WHO said rare H10 infections have been found in Australia, Egypt, and China, and targeted surveillance in birds has found H10N3, but the extent of transmission is unclear. Human infections with avian flu viruses, including H10 strains, are usually linked to contact with birds, and sporadic infections are likely to continue, the WHO said. So far, it doesn't appear that H10 viruses have the capacity for sustained human-to-human transmission, so the likelihood of spread is low, the agency added.
Jun 10 WHO statement
Jun 1 CIDRAP News scan

 

GPEI launches new polio campaign as 2 nations report more cases

The Global Polio Eradication Initiative (GPEI) yesterday launched a new eradication strategy after pausing door-to-door campaigns for 4 month last year to curb the spread of COVID-19.

"With this new Strategy, the GPEI has clearly outlined how to overcome the final barriers to securing a polio-free world and improve the health and wellbeing of communities for generations to come," said Tedros Adhanom Ghebreyesus, PhD, director-general of the WHO, in a WHPO news release. "Polio eradication is at a pivotal moment. It is important we capitalize on the momentum of the new Strategy and make history together by ending this disease."

The campaign comes as GPEI reported that both Afghanistan and Burkina Faso had new cases of circulating vaccine-derived poliovirus type 2 (cVDPV2), and the WHO declared a polio outbreak in the Philippines over.

In announcing the new initiative, GPEI said the COVID-19 pandemic halted progress toward polio eradication, resulting in an increase in polio cases. Last year, 1,226 cases of all forms of polio were recorded, compared with only 138 in 2018, GPEI said. The group contributed up to 30,000 program staff and over $100 million in polio resources to support pandemic response in almost 50 countries.

Meanwhile, in Afghanistan, 1 case of cVDPV2 was recorded in Badghis this week, bringing the number of 2021 cases to 40. Last year Afghanistan reported 308 cVDPV2 cases. Burkina Faso recorded its second cVDPV2 case of the year; in 2020, the African nation had 62 cases.

And after polio re-emerged in the Philippines in September of 2019, the country is once again polio-free. No cases have been detected for 16 months, and the country completed a massive vaccination campaign that included 30 million doses of oral polio vaccine, the Associate Press reported.
Jun 10 WHO news release
Jun 11 GPEI update
Jun 11 Associated Press story

Stewardship / Resistance Scan for Jun 11, 2021

News brief

New WHO documents focus on tailored antimicrobial stewardship

The World Health Organization (WHO) this week released three new documents that aim to address antimicrobial resistance (AMR) through a behavioral insights approach.

The documents are based on the Tailoring Antimicrobial Resistance Programmes (TAP) approach, which aims to help stakeholders develop targeted stewardship interventions that are tailored toward the needs of specific groups (such as prescribers, pharmacists, patients, and veterinarians) and contexts (communities, pharmacies, and hospitals).

The TAP Quick Guide is a "how to" for rapid and practical application of the TAP approach, while the TAP Toolbox contains tools and templates for each stage of the approach. The TAP Process poster provides a visual description of the step-by-step approach to designing and implementing TAP interventions. A fourth document, the TAP Manual, will be published at the end of the year.

"These new tools offer practical actions and measures to stop the spread of AMR, which is essential to saving lives and ensuring the continued usefulness of antibiotics, and is part of being responsible and effective practitioners and consumers," Nino Berdzuli, MD, MPH, director of the WHO's Division of Country Health Programmes, said in a press release from the WHO Regional Office for Europe.

The WHO says TAP pilot projects are under way in several European region countries, including the United Kingdom, Sweden, Hungary, North Macedonia, and Kazakhstan.
Jun 10 WHO/Europe press release

 

UK group reports decline in antibiotic use in pigs

A report yesterday from the UK Agriculture and Horticulture Development Board (AHDB) shows that antibiotic use by UK pig farmers declined last year, bringing the total reduction since 2015 to 62%.

Using data from the electronic Medicines book (eMb), which cover 95% of slaughter pigs in the United Kingdom, the report found that total antibiotic usage in pigs fell 5% from 2019 levels, from 110 milligrams (mg) per population correction unit (PCU) to 105 mg/PCU. The use of highest-priority critically important antibiotics saw a slight increase (from 0.04 mg/PCU to 0.052 mg/PCU), but overall it remains at very low levels. No use of colistin, a last-resort antibiotic for multidrug-resistant infections in humans, was reported in 2020.

ADHB officials say the decline brings the UK pig industry close to the target level of 99 mg/PCU, set in 2015.

"The sector has delivered sustained reductions since recording began via eMB in 2015," AHDB Sector Strategy Director for Pork Angela Christison said in an AHDB press release. "This continued improvement, despite disruption to pig flow during the pandemic, is a credit to collaboration between producers, vets and the industry as a whole."

The UK pig industry has set a goal of an additional 30% reduction by 2024.
Jun 10 AHDB press release
Jun 10 AHDB report

ASP Scan (Weekly) for Jun 11, 2021

News brief

Our weekly wrap-up of antimicrobial stewardship & antimicrobial resistance scans

New WHO documents focus on tailored antimicrobial stewardship

The World Health Organization (WHO) this week release three new documents that aim to address antimicrobial resistance (AMR) through a behavioral insights approach.

The documents are based on the Tailoring Antimicrobial Resistance Programmes (TAP) approach, which aims to help stakeholders develop targeted stewardship interventions that are tailored toward the needs of specific groups (such as prescribers, pharmacists, patients, and veterinarians) and contexts (communities, pharmacies, and hospitals).

The TAP Quick Guide is a "how to" for rapid and practical application of the TAP approach, while the TAP Toolbox contains tools and templates for each stage of the approach. The TAP Process poster provides a visual description of the step-by-step approach to designing and implementing TAP interventions. A fourth document, the TAP Manual, will be published at the end of the year.

"These new tools offer practical actions and measures to stop the spread of AMR, which is essential to saving lives and ensuring the continued usefulness of antibiotics, and is part of being responsible and effective practitioners and consumers," Nino Berdzuli, MD, MPH, director of the WHO's Division of Country Health Programmes, said in a press release from the WHO Regional Office for Europe.

The WHO says TAP pilot projects are under way in several European region countries, including the United Kingdom, Sweden, Hungary, North Macedonia, and Kazakhstan.
Jun 10 WHO/Europe press release

 

UK group reports decline in antibiotic use in pigs

A report yesterday from the UK Agriculture and Horticulture Development Board (AHDB) shows that antibiotic use by UK pig farmers declined last year, bringing the total reduction since 2015 to 62%.

Using data from the electronic Medicines book (eMb), which cover 95% of slaughter pigs in the United Kingdom, the report found that total antibiotic usage in pigs fell 5% from 2019 levels, from 110 milligrams (mg) per population correction unit (PCU) to 105 mg/PCU. The use of highest-priority critically important antibiotics saw a slight increase (from 0.04 mg/PCU to 0.052 mg/PCU), but overall it remains at very low levels. No use of colistin, a last-resort antibiotic for multidrug-resistant infections in humans, was reported in 2020.

ADHB officials say the decline brings the UK pig industry close to the target level of 99 mg/PCU, set in 2015.

"The sector has delivered sustained reductions since recording began via eMB in 2015," AHDB Sector Strategy Director for Pork Angela Christison said in an AHDB press release. "This continued improvement, despite disruption to pig flow during the pandemic, is a credit to collaboration between producers, vets and the industry as a whole."

The UK pig industry has set a goal of an additional 30% reduction by 2024.
Jun 10 AHDB press release
Jun 10 AHDB report

 

FDA finalizes guidance for topical, injectable antibiotics used in animals

Originally published by CIDRAP News Jun 10

The Food and Drug Administration (FDA) announced today that it has finalized guidelines to bring the remaining medically important antibiotics still sold over-the-counter (OTC) for use in animals under the supervision of veterinarians.

The finalization of guidance for industry (GFI) #263 means that the roughly 4% of medically important antibiotics that are currently marketed as OTC products for use in livestock and companion animals will require a prescription from a licensed veterinarian going forward. It builds on previous FDA guidance (GFI #213), which brought 96% of all medically important antibiotics used in animal water and feed under veterinary supervision and limited their use to treatment, control, or prevention of specific diseases.

The remaining 4% of medically important antibiotics not covered by GFI #213 include other dosage forms, such as injectables and topicals. The new guidance outlines the process for animal drug sponsors to voluntarily change the labels on these products from OTC to prescription.

The FDA says the new guidelines will be implemented over a 2-year timeframe.

"The agency is committed to working with affected stakeholders to facilitate the transition process and to minimize impacts on animal health," the agency said in a press release. "During the two-year timeframe for implementation recommended in GFI #263, FDA plans to work with affected stakeholders and state partners to answer questions about the voluntary transition process and provide assistance where possible." 
Jun 10 FDA press release

 

BARDA grants additional funding for rapid antibiotic susceptibility test

Originally published by CIDRAP News Jun 10

Selux Diagnostics announced this week that it has been awarded an additional $14.6 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to commercialize its Next Generation Phenotyping (NGP) platform for rapid antibiotic susceptibility testing (AST).

BARDA granted the additional funding after Selux completed its first clinical trial, which confirmed the NGP platform's ability to provide rapid, accurate AST results for a wide array of antibiotics from cultured isolates. Selux plans to submit the clinical results to the FDA to begin the process of commercialization.

BARDA has now awarded a total of $60.8 million to Selux to support the project.

"A global crisis of antibiotic resistance requires innovation to save lives, and we believe this next generation technology represents the future backbone of microbiology," Selux CEO Steve Lufkin said in a company press release. "Our plan is to build on the success of this first clinical study and turn our attention to the next phase of product development to speed the time to targeted antibiotic treatment further, preserving the lifesaving power of antibiotics for future generations."
Jun 8 Selux press release

 

CARB-X to fund development of rapid diagnostic test for sepsis

Originally published by CIDRAP News Jun 8

CARB-X announced today that is awarding Tucson, Arizona–based Accelerate Diagnostics $578,000 to develop a diagnostic test for sepsis based on new fiber optic technology.

The award will help the company develop a compact instrument that uses Stimulated Raman Spectroscopy to identify bacteria from positive blood culture with minimal sample processing within 15 minutes. The technology, which is currently in the feasibility phase of development, has demonstrated high sensitivity and specificity and the ability to identify a wide range of bacterial pathogens.

Sepsis, which is the body's overwhelming and life-threatening reaction to an infection, causes an estimated 11 million deaths each year. Quick diagnosis of the causative pathogen is considered critical for appropriate treatment.

Accelerate would be eligible for up $2.1 million in additional funds from CARB-X (the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator) if the project meets certain milestones.

"Prompt diagnosis and treatment provide the best chance for reducing death rates and improving recovery from sepsis," CARB-X Research and Development Chief Erin Duffy, PhD, said in a CARB-X press release. "Accelerate's technology aims to speed up delivery of diagnostic test results which would help clinicians make treatment decisions in the first critical hours of illness."

Since its launch in 2016, CARB-X has awarded more than $480 million in funding to support the development of antibiotics, vaccines, diagnostics, and other products focused on antibiotic-resistant bacteria.
Jun 8 CARB-X press release

 

GARDP announces funding from Japan for antibiotic development

Originally published by CIDRAP News Jun 8

The Global Antibiotic Research and Development Partnership (GARDP) announced yesterday that it has received additional funding from the Japanese government to support its efforts to fight antibiotic-resistant infections.

The 200 million yen (US $1.8 million) investment by the government of Japan, the second payment of a 1 billion yen (US $9 million) pledge to GARDP over 5 years, will be used to accelerate research and development into treatments for the antibiotic-resistant "priority pathogens" identified by the WHO, and ensure that these treatments are used responsibly and are accessible to all who need them. The funding covers the period April 2021 to March 2002

"We would like to express our gratitude to the Government of Japan, through the Ministry of Health, Labour and Welfare, for its ongoing support and commitment to addressing the silent pandemic of drug-resistant infections," GARDP Executive Director Manica Balasegaram, MRCP, MSc, said in a press release. "This funding signals Japan's leadership in global health, and recognition that achieving the UN Sustainable Development Goals will require urgent action to deliver effective antibiotics, available for every person who needs them."
Jun 7 GARDP press release

 

Trial of rapid respiratory tests finds no reduction in antibiotics

Originally published by CIDRAP News Jun 7

The use of rapid respiratory pathogen (RRP) testing among children with influenza-like illness (ILI) did not reduce antibiotic prescribing, according to a randomized clinical trial published late last week in JAMA Network Open.

The single-center trial, conducted by investigators with the University of Colorado School of Medicine and Children's Hospital Colorado, involved children aged 1 month to 18 years who presented to the emergency department with ILI from Dec 1, 2018, to Nov 30, 2019. All children received a nasopharyngeal swab for RRP testing and were randomized 1:1 to an intervention group, in which the emergency department (ED) clinician and families of children received test results, and a control group that did not. The primary outcome was antibiotic prescribing during the ED visit. Secondary outcomes included antiviral prescribing, ED length of stay, and hospital admission.

The cohort consisted of 908 children, with 452 in the intervention group and 456 in the control group. The median age was 2.1 years, and there were no significant differences in demographic and clinical characteristics between the two groups. Positive RRP test results were obtained for 795 of 931 visits (85%). The most common pathogens were enterovirus (n=295), influenza (180), respiratory syncytial virus (162), and adenovirus (115).

In the intention-to-treat (ITT) intervention group, children were more likely to receive antibiotics (relative risk [RR], 1.3; 95% confidence interval [CI], 1.0 to 1.7), with no significant differences in antiviral prescribing, medical visits, and hospitalization. In a modified ITT analysis, children whose clinician knew the RRP test results were more likely to receive antivirals (RR, 2.6; 95% CI, 1.6 to 4.5) and be hospitalized (RR, 1.8; 95% CI, 1.4 to 2.5) than those whose clinicians did not know the test results, but antibiotic prescribing was not significantly different (RR, 1.1; 95% 0.9 to 1.4).

"The results of this randomized clinical trial show that RRP testing for children with acute respiratory illnesses in an ED setting did not lead to a decrease in antibiotic prescribing," the study authors wrote. "The greatest effect on clinicians' clinical decision-making was appropriate antiviral use for children based on influenza test results, supporting the potential benefit for rapid molecular influenza testing in this setting."
Jun 4 JAMA Netw Open study

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