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[av_heading heading=’WHO AWaRe Antibiotic Book’ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-desktop-font-size-title=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-desktop-font-size=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-desktop-font-size-1=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ av-desktop-margin=” av-desktop-margin_sync=’true’ av-medium-margin=” av-medium-margin_sync=’true’ av-small-margin=” av-small-margin_sync=’true’ av-mini-margin=” av-mini-margin_sync=’true’ headline_padding=” headline_padding_sync=’true’ av-desktop-headline_padding=” av-desktop-headline_padding_sync=’true’ av-medium-headline_padding=” av-medium-headline_padding_sync=’true’ av-small-headline_padding=” av-small-headline_padding_sync=’true’ av-mini-headline_padding=” av-mini-headline_padding_sync=’true’ padding=’10’ av-desktop-padding=” av-medium-padding=” av-small-padding=” av-mini-padding=” icon_padding=’10’ av-desktop-icon_padding=” av-medium-icon_padding=” av-small-icon_padding=” av-mini-icon_padding=” link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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In December 2022, the World Health Organisation (WHO) released the WHO AWaRe Antibiotic Book. AWaRe (which stands for access, watch and reserve) is a concise, evidence-based guide for choosing antibiotics, doses, routes of administration and duration of treatment for more than 30 of the most common clinical infections in children and adults, in both primary health care and hospital settings. For ease of use, the book is also available in the form of infographics and an online web application, which provides a quick-reference guide for health care professionals at the point of care.

Up until now, easily accessible, evidence-based guidance from trusted sources has been lacking for many common infections in many countries, especially in low- and middle-income settings. The AWaRe antibiotic book is expected to be of particular value in those settings where WHO guidance might be the only high-quality information source available.

Through the Global Action Plan on AMR, WHO is working to improve the surveillance of antimicrobial resistance and reduce inappropriate antibiotic consumption. VALUE-Dx shares WHO’s concern that antimicrobial resistance poses a threat to public health globally, and contributes to the fight against AMR by validating diagnostics to optimize antibiotic use. Find out more here.
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[av_heading heading=’VALUE-Dx gives recommendations for CA-ARTI diagnostics in new report’ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-desktop-font-size-title=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-desktop-font-size=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-desktop-font-size-1=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ av-desktop-margin=” av-desktop-margin_sync=’true’ av-medium-margin=” av-medium-margin_sync=’true’ av-small-margin=” av-small-margin_sync=’true’ av-mini-margin=” av-mini-margin_sync=’true’ headline_padding=” headline_padding_sync=’true’ av-desktop-headline_padding=” av-desktop-headline_padding_sync=’true’ av-medium-headline_padding=” av-medium-headline_padding_sync=’true’ av-small-headline_padding=” av-small-headline_padding_sync=’true’ av-mini-headline_padding=” av-mini-headline_padding_sync=’true’ padding=’10’ av-desktop-padding=” av-medium-padding=” av-small-padding=” av-mini-padding=” icon_padding=’10’ av-desktop-icon_padding=” av-medium-icon_padding=” av-small-icon_padding=” av-mini-icon_padding=” link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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Antimicrobial resistance (AMR) is a global public health threat which is the cause of numerous deaths and medical complications. One major driver for AMR is the inappropriate use of antibiotics, such as in the treatment of community-acquired acute respiratory tract infections (CA-ARTI).

In November 2022, Work Package 5 of VALUE-Dx published a report on their 5.4 Deliverable. The aim of the study was to develop recommendations for fit-for-purpose policies in funding and pricing to improve the uptake of CA-ARTI point-of-care testing (POCT) in the outpatient sector. The report presents such policy recommendations, which are supplemented by some additional advice on health technology assessments (HTA) and overarching considerations. 

One of the goals of Work Package 5 is to review and analyse the current policy environment in Europe and identify good practices for the assessment of innovative diagnostics. WP5 also strives to develop proposals for fit-for-purpose policies, to accelerate market entry of and accessibility to cost-effective diagnostics with the potential to be applied to reduce AMR.

In the report, a total of fifteen recommendations targeted at policy-makers are proposed. Ten of them have been clustered in the policy areas of HTA, pricing and procurement, and funding. Five additional recommendations refer to overarching aspects that are conducive to the successful implementation of peri-launch policies. Read the report here.

 
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[av_heading heading=’WAAW 2022 theme announced ‘ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ padding=’10’ icon_padding=’10’ headline_padding=” headline_padding_sync=’true’ link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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This year’s World of Antimicrobial Awareness Week (WAAW) theme is ‘Preventing antimicrobial resistance together’. It was announced by the Quadripartite organisations, which includes the Food and Agriculture Organisation of the United Nations (FAO), the United Nations Environment Programme (UNEP), the World Health Organisation (WHO), and the World Organisation for Animal Health (WOAH, founded as OIE).

The WAAW takes place every year from 18 to 24 November. The 2022 topic focuses on a One Health approach and inspires collaboration across sectors. AMR is a threat to humans, animals, plants and the environment  and fighting it is a global endeavour. 

Discover more here. 
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[av_heading heading=’Ecraid press release on European response to monkeypox virus outbreak’ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ padding=’10’ icon_padding=’10’ headline_padding=” headline_padding_sync=’true’ link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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Utrecht, 7 July 2022 – Ecraid is assessing its readiness to respond in the event the monkeypox outbreak spreads further in Europe. These preparations are proportionate to the current relatively low risk of this infection for European citizens. Ecraid is currently operating in outbreak response mode 2 (mobilisation) for adults, and in outbreak response mode 1 (preparedness) for children, the second and first of three response modes.

Outbreak

Early May 2022 a multi-country outbreak of monkeypox virus (MPXV) started affecting the United Kingdom (UK), the EU/EEA, Asia, the Americas, and Australia. The virus spreading outside of the known enzootic countries in the African region has been designated clade 3 MPXV. Cases that are thought to be linked to this outbreak have been reported from 31 countries and areas throughout the European region, and other countries. Most recognized infections are in men with high-risk exposure for transmission (men who have sex with men), and disease transmission outside this population is still rare, but there is some concern that expansion of the risk group is possible if the outbreak continues to evolve. The clinical manifestations of clade 3 MPXV infections are usually mild, and most people in the current outbreak have recovered within weeks. More severe disease has been reported in studies from African countries with enzootic presence of monkeypox, with outbreaks with clade 3 MPXV with a case-fatality rate up to 3% in Nigeria. The highest case fatality rates have been reported for children and young adults, as well as immunocompromised individuals.

Treatment for monkeypox is mostly symptomatic. Tecovirimat was approved by the European Medicines Agency (EMA) for treatment of monkeypox throughout the EU on 6 January 2022. Tecovirimat has been authorised under ‘exceptional circumstances’, as it has not been possible to obtain complete information about tecovirimat efficacy and safety in human monkeypox due to the rarity of the disease. Persons with severe disease, immunocompromised patients, children younger than 8 years, and pregnant individuals could be considered for antiviral treatment.

Although the exact extent of the outbreak remains to be established, these events have triggered an assessment of the level of preparedness of clinical research networks in Europe for possible deployment in case of further spread. The EU has invested in the development of these European clinical networks over many years to ensure preparedness for delivering clinical research in response to new infectious disease outbreaks. These networks include Ecraid: The European Clinical Research Alliance for Infectious Diseases (With the support of funding provided by the EU, Europe is now much better prepared to speed up the processes of clinical research to the extent that findings are generated in real time to inform practice when it is most useful, in the midst of an outbreak, rather than once the threat has passed.

How Ecraid is responding

Information on Ecraid’s response modes and implications can be found here. Activities are planned and conducted in close collaboration with our partner networks (EU-RESPONSE and VACCELERATE) and the European Union and in alignment with those of WHO, ECDC and EMA. The preparations made by Ecraid as part of its mode 1 and 2 responses are briefly summarised below.

Ecraid participates in the MOSAIC study (led by University of Oxford as the sponsor and ANRS/Inserm representant of the sponsor in Europe). This is an observational study of the natural history of monkeypox disease in children and adults. With its collaborative network, Ecraid will identify study sites for participation in MOSAIC in those countries not yet participating. Together with its partners ANRS/Inserm, University of Oxford and UMC Utrecht, the alliance also participates in the preparation of a randomized controlled trial evaluating the effectiveness of tecovirimat. Moreover, Ecraid offers countries access to serology and sequencing capacity in its network (e.g., Erasmus MC).

Through its partners with expertise in pediatric infections (PENTA-ID, UMC Utrecht and Erasmus MC), Ecraid will develop a scientific research agenda in the event that monkeypox infections emerge in children. The first initiatives for preparation have focused on the use of Imvanex in adults and children as Post-Exposure Prophylaxis or Pre-Exposure Prophylaxis. Imvanex is not licensed for children under 18 years but is used off-label for exposed children. There is no standardized protocol for follow-up of these children and the possibilities of a cohort study looking at immunogenicity, break-through infections and adverse events is being explored with several European countries. Study developments will be discussed with EMA, and execution will be aligned with VACCELERATE.

The standing Ecraid Outbreak Mode Committee (Prof. Marion Koopmans of the Erasmus Medical Center in Rotterdam, Prof. Peter Horby of the University of Oxford, Prof. Herman Goossens of the University of Antwerp, Prof. Yazdan Yazdanpanah and Prof. Marc Bonten, University Medical Center) continue to follow the events closely to ensure Ecraid’s clinical research response remains aligned with the risk to health and security of European citizens.

Quotes

Prof. Marc Bonten (UMC Utrecht and CEO of Ecraid): “Ecraid has been established to enhance our capacity in Europe to mount a rapid clinical research response to any new infectious disease threat. Monkeypox may become such a threat, and that’s why we have started preparations for clinical studies now.”

Prof. Yazdan Yazdanpannah (ANRS/Inserm): “Threats related to new emerging pathogens or re-emerging infectious diseases appear regularly and the frequency of their occurrence is increasing. This is again illustrated by the unprecedented and unexpected outbreak of human monkeypox cases across Europe, the Americas, and Australia. A United Europe of Research is key to respond to epidemics/pandemics. Research infrastructures such as Ecraid and its partner networks EU-RESPONSE and VACCELERATE are very important tools of response.”

Prof. Peter Horby (Oxford University): “The unanticipated emergence of monkeypox outside of Africa is a perfect case-study of how threats anywhere can become threats everywhere and exemplifies the need to work as a global community to identify and counter all infectious disease problems, wherever they occur and whomever they affect.”

Prof. Marion Koopmans (Erasmus MC, Rotterdam): “While we do not foresee a surge of monkeypox cases in the near future, preparedness does require scenario thinking and preparing for those scenarios. In Ecraid, we do that for possible trajectories that may evolve if the current public health response does not lead to containment of the outbreak.”

Prof. Herman Goossens (Antwerp University): “The European clinical trial networks, expanded during the COVID-19 pandemic thanks to significant EU funding, are providing the sustainable infrastructures for the response to the monkeypox threat.”

About Ecraid

The European Clinical Research Alliance for Infectious Diseases (Ecraid) is a not-for profit foundation that advances clinical research in the field of infectious diseases by establishing a long-term, financially self-sustainable, clinical research network in Europe. Headquartered in Utrecht, the Netherlands, Ecraid is the first network of its kind in Europe to offer a single point of access to a pan-European clinical research network for infectious diseases and spans 1,100 clinical sites and 900 laboratories across 42 countries. For more information, please visit www.ecraid.eu.

ECRAID PRESS RELEASE
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[av_heading heading=’POC Diagnostics in General Practice: the Effects on Antimicrobial Resistance’ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ padding=’10’ icon_padding=’10’ headline_padding=” headline_padding_sync=’true’ link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kyba6fbz’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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In June 2022, VALUE-Dx contributed to a new publication titled ‘The Opportunity of Point-of-Care Diagnostics in General Practice: Modelling the Effects on Antimicrobial Resistance’, that appeared in the open-access journal PharmacoEconomics. The aim of the study was to quantify the investments required for a large-scale rollout of point-of-care (POC) diagnostic testing in Dutch primary care, as well as the impact on antimicrobial resistance (AMR) due to reduced use of antibiotics. 

AMR is a public health threat that is mainly caused by unnecessary use of antibiotics. Community-acquired acute respiratory tract infections (CA-ARTIs) are a major driver of antibiotic consumption in primary care. It is estimated that each year more than 650.000 infections and 30.000 attributable deaths in Europe or 1.27 million deaths worldwide are caused by resistant organisms. 

An individual-based model was developed to simulate CA-ARTI consultations at Dutch GP practices. It compared a scenario where GPs test all CA-ARTI patients with a hypothetical diagnostic strategy to a scenario where the current standard-of-care is continued for the years 2020-2030. Differences in costs and future AMR rates were estimated. 

Results of the study

The results show that improved diagnostics may reduce AMR in the next decade, but that there also are major costs associated. When comparing the current standard-of-care to the diagnostic algorithm, the latter increases the total costs of GP consultations for CA-ARTI by 9% and 19%, when priced at €5 and €10. The hypothetical diagnostic strategy can partly restrain the forecast increase in Streptococcus pneumoniae resistance against penicillins from 3.8 to 3.5% in 2023, albeit with considerable uncertainty.       

Conclusions

The results show that the costs of consultations increase, while antibiotic consumption and AMR decrease when implementing a hypothetical diagnostic strategy for all CA-ARTI patients in primary care. Interventions with limited gains for individual patients, but considerable potential related to antibiotic consumption and AMR, can require novel health-economic methods to assess and communicate the potential benefits related to AMR.   

You can read the publication here. 
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[av_heading heading=’Diagnostics for AMR: Building back better from the COVID-19′ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ padding=’10’ icon_padding=’10’ headline_padding=” headline_padding_sync=’true’ link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kyba6fbz’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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The VALUE-Dx project encouraged all relevant stakeholders to partake in a Massive Open Online Course (MOOC) on Diagnostics for AMR: Building back better from the COVID-19 pandemic, developed by the London School of Hygiene & Tropical Medicine in partnership with Becton, Dickinson and Company (BD).

This free three-week course provided valuable insight into how COVID-19 has affected country AMR programmes and how countries can explore the lessons and benefits that the responses to the COVID-19 pandemic hold for AMR. You were able to learn at your own pace with a faculty of leading experts in COVID-19 and AMR and be part of the largest community of AMR professionals on the cutting edge of new information.

• You learned about diagnostic technology innovations and diagnostic capacity increases developed in response to the COVID-19 pandemic and how they can be applied to the AMR response.
• You learned about the importance of quality and data systems for AMR diagnostics and AMR data sharing to strengthen surveillance and reporting, and opportunities for professional development as part of a culture of continuous learning.
• You got the opportunity to join discussion forums to share your knowledge and views with colleagues and benefit from the experiences of other learners from around the world.

How can the COVID-19 pandemic help us defeat Antimicrobial Resistance?

Having the latest data for COVID-19 allows policy makers, clinicians, and the public to do their part in the fight against this pandemic. Many countries still lack sufficient data on antimicrobial resistance (AMR) trends to develop national and local treatment guidelines and policies. “Without data, you are just a person who has another opinion…with data, you can convince people there is an issue”, says Dr. Amal Saif Al-Maani, AMR expert from Oman.

In addition, we have made numerous investments in science, diagnostic testing capacity, and innovations in data systems we can leverage to do better with AMR before it’s too late. “Now is the time to learn more about the diagnostic technology innovations and diagnostic capacity increases that developed in response to COVID-19, and how they can be applied to the AMR response”, says Professor Rosanna Peeling, Director and Chair of Diagnostics at the International Diagnostics Centre at the London School of Hygiene and Tropical Medicine.

COURSE SYLLABUS

Week 1 – Updates on the AMR response and the impact of the COVID-19 pandemic

Week 2 – Better diagnosis, surveillance and reporting for AMR

Week 3 – Building back better for a robust and sustainable AMR response
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