Antimicrobial Resistance - Q4 - Nov 2018

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Antimicrobial Resistance

Jesús Rodríguez-Baño President-Elect of ESCMID on the challenges AMR is creating for the development of modern medicine P2 Dr Manica Balasegaram Executive Director of GARDP on the importance of investing in a global, public, health-driven approach to tackling AMR P5

Dr Diane Ashiru-Oredope The importance of antimicrobial stewardship in the global battle to contain antibiotic resistance P4 Image: Lead Pharmacist, AMR Programme, National Infection Service, Public Health England Global AMR lead, Commonwealth Pharmacists Association

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IN THIS ISSUE Jean Carlet The importance of diagnostic tests to prevent antibiotic resistance and treat resistant bacteria ONLINE

Maurizio Sanguinetti The threat of fungal pathogens and antifungal drug resistance ONLINE

Tracey Guise The need to raise awareness of antimicrobial resistance, especially in schools ONLINE

Antimicrobial resistance represents a challenge for the development of modern medicine

Jesús Rodriguez-Baño President-Elect, European Society of Clinical Microbiology and Infectious Diseases

Nobody doubts today that antimicrobial resistance is a very serious public health problem that may jeopardise the development of modern medicine. The United Nations, the World Health Organization and the European Centre for Disease Control have expressed their concerns and need for action.

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o fight antimicrobial resistance (AMR), we must see asignificant reduction in the consumption of antibiotics in agriculture, animals and humans, particularly for all inappropriate use.

Currently, transmission of resistant bacteria through water, food and contact, is high and must be drastically reduced, and we must see a reduction in the occurrence of infection through vaccination and preventive measures. New rapid diagnostic tools and treatments must be developed, including new antibiotics and nonantibiotic approaches.

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We can achieve all of these measures by prioritising AMR in the political agenda and dedicating funds for research. Such research will allow us to better understand the molecular and epidemiological variables influencing the problem, and discover new tools. It is vital that we do so in order that microbes – such as those causing common infections like pneumonia, pyelonephritis or intraabdominal abscesses – do not outpace us with their resistance to our antibiotics. The results to society would be catastrophic.

We need to educate both the general population and healthcare professionals to the dangers of AMR, and effectively fight the antivaccines movement, which puts so many at risk. We can help prevent the need for antibiotic prescription by investing in sanitary solutions in mid- and low-income countries, by improving hand hygiene and other transmission preventive measures, and we can lower the opportunity for resistance by implementing MediaplanetUK

interventions in antibiotic use and infection prevention.

What are the barriers?

The problem of AMR is so complex, that it is difficult to identify priorities. The numerous actors that need to be involved pose some organisational difficulties.

The economic situation in many countries has had an important impact in the resources dedicated to this problem, for example, the economic impact of some measures in the agriculture and food industry must be considered and addressed.

There is an increasing complexity of modern medicine in terms of antibiotic use and infection prevention, which must be taken into account also.

have a committee dedicated to antimicrobial susceptibility testing (EUCAST) and another to infection control (EUCIC); we also have several study groups developing activities in the field.

ESCMID dedicates important efforts to educational activities in antimicrobial resistance, as technical workshops, postgraduate courses and an international master’s degree, provides grants for observerships in hospitals with advanced programmes in antibiotic stewardship and infection control, and for research projects. We develop guidelines to help in the use of antibiotics and prevention of transmission of resistant organisms and disseminate relevant information for the fight of resistance.

What is ESCMID doing about AMR? The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) has AMR among its priorities. In fact, we

Can we be optimistic?

We can, partially. The problem of antimicrobial resistance is now present in the health political agenda, but it may not be high enough in some countries or institutions. Some

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countries have taken actions and put forward resources, but the situation is very heterogeneous, and a global and comprehensive policy is needed.

The level of awareness of the population and professionals is higher than a few years ago, but a much more important change in behaviour and culture is still needed.

Antimicrobial resistance is more present in the education and training of professionals. Important measures related to the use of antibiotics in non-human environments are being implemented in many countries.

Many hospitals in the world are implementing or improving their antibiotic stewardship and infections control programmes, but again there is a huge heterogeneity.

Despite the insufficient number of (and innovation in) solutions, new antimicrobials and non-antimicrobial approaches are being developed.

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Diagnostics are pivotal in curbing antimicrobial resistance “If antimicrobial resistance gets out of hand, it will leave a heavy mark on the whole healthcare chain. Committed to serve public health for more than 55 years, bioMérieux believes that diagnostics have a pivotal role to play in fighting this threat,” says Mark Miller, Executive VP and Chief Medical Officer, bioMérieux.

Mark Miller Executive Vice President and Chief Medical Officer, bioMérieux

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ntimicrobial resistance (AMR) is probably the single biggest health threat that we face globally, with individuals dying from infections, which have become untreatable.

In 2016, the UK’s O’Neill Report estimated that antimicrobial resistance would cause more than 10 million deaths and produce trillions of dollars of GDP loss by 2050, a significant under-estimate since many resistant pathogens (Acinetobacter, Pseudomonas, Salmonella, etc.) were not included in these forecasts.

Unfortunately, AMR surveillance is incomplete in most of the world.

The real dangers of an increase in AMR The rise of AMR will have dire consequences on individuals, healthcare systems and the global economy. Routine minor surgery will carry higher risks due to the possibility of a resistant infection. Elective surgeries like joint replacements will carry tremendous risks of untreatable infectious complications. The immunosuppressing treatment of cancers and leukemias would result in high rates of antibiotic-resistant deaths. Common conditions like pneumonia could become lethal to large proportions of the population once again in this “post-antibiotic era”.

How can diagnostics help in the fight against AMR? Diagnostic tests have a key role to play in combatting AMR in three principal ways: • They are mandatory to conduct AMR surveillance (to measure and track resistance).

• They are crucial in determining the optimal therapy for an individual.

• They are vital for reducing inappropriate antibiotic use in an Antibiotic Stewardship programmes.

Surveillance Diagnostics enable surveillance of pathogens and resistance on a local, regional and global scale, this being instrumental to understand the extent of AMR and how to address it.

Knowing AMR epidemiology determines the actions necessary for its control. bioMérieux is the unique sponsor of the world’s largest AMR surveillance: the Global Point Prevalence Survey (GLOBAL-PPS), co-developed with the University of Antwerp (Belgium), whose aim is to measure antibiotic and diagnostics utilisation as well as resistance. In using developed, low- and middleresource countries as participants, it seeks to improve antibiotic use and slow the emergence of AMR in participating hospitals.

Individual diagnosis Diagnostics enable the optimisation of a patient’s therapy. Antibiotics are not necessary for all infections (viral infections do not respond to antibiotics) and can result in symptomatic side effects and allergic reactions, as well as the induction of antibiotic resistance in the person’s “normal flora”.

When antibiotics are necessary, diagnostic tests provide valuable information on the responsible pathogen and the choice of treatment that is most effective.

Antimicrobial Stewardship Diagnostics are key tools to effectively accomplish Antimicrobial Stewardship (the right treatment for the right patient at the right time). Stewardship programmes using diagnostic tools have achieved substantial reductions in antibiotic use in a safe and effective manner, thereby combating AMR. Innovations in diagnostics Faster and more accurate diagnostic tests will improve AMR surveillance, help to choose the most appropriate therapy for an individual, and are pivotal in stewardship programmes.

One such innovation is the “syndromic approach,” using highly multiplex nucleic acid-based tests, which quickly and efficiently test for more than 90% of the pathogens responsible for a given syndrome, providing actionable information rapidly.

Also, the use of procalcitonin (PCT), a blood biomarker indicating a bacterial infection, in suspected or confirmed pneumonia and sepsis, has significantly reduced antibiotic use in safe and effective ways. Highly automated blood culture systems and faster antibiotic susceptibility testing are other innovations resulting in more useful information given to healthcare providers.

What are the next steps?

Funding and support for diagnostic research and innovation The development of diagnostics to address AMR is poorly funded in

most countries. Aside from support for novel antibiotics and vaccines, R&D financial incentives for diagnostics will be crucial.

Assessment of medical value Innovative diagnostics need harmonised Health Technology Assessment (HTA) methods that can be used within and between countries. The results of these HTAs should be used to derive the true medical value of a diagnostic test, facilitating adoption and reimbursement – especially true for diagnostics to combat AMR. Reimbursement In general, reimbursement of diagnostic tests is not based on HTAs or on the improvement in medical outcomes, despite the fact that they can contribute to better patient care, optimised outcomes, reduced costs and other measurable benefits.

Reimbursement of diagnostics should be correlated with the medical value that they impart to the patient and the healthcare structure, as determined by harmonised and validated HTAs measuring AMRspecific outcomes.

Evolution of practice The behaviour of physicians, nurses, pharmacists and infection control practitioners in the use and adoption of diagnostics is key for our success.

Diagnostics are generally underused, but improved uptake can be achieved by improving their familiarity and utility among these groups, leading to better patient outcomes and a slowing of AMR growth and spread.

Education around how diagnostics can benefit AMR Knowledge about diagnostics availability, performance, utility and their key role in combating AMR - is mostly absent from the educational curricula of healthcare professionals.

The in-depth education of these groups is essential, since they are the ones who can effect change and, in turn, educate the general public about diagnostics and AMR. Why a combined effort is necessary?

AMR is a serious reality today, without sufficient awareness of its extent and consequences at political, social and economic levels. There is a lack of focus on the pivotal role of diagnostics in preventing and controlling global AMR. Increase understanding of this public health threat and its dire consequences needs to penetrate all levels of society to improve the situation and to protect future generations from a world without effective antibiotics.

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Driving down inappropriate antibiotic prescribing globally Capability

Motivation

Behaviour

Figure 1 COM-B and behaviour change wheel Michie, S. et al. The behaviour change wheel: A new method for characterising and designing behaviour change interventions.

Implement. Sci. 6, 42 (2011)

Opportunity

Dr Diane Ashiru-Oredope Lead Pharmacist, AMR Programme, National Infection Service, Public Health England Global AMR Lead, Commonwealth Pharmacists Association

Monitoring antimicrobial use and development of antimicrobial stewardship programmes is essential for tackling AMR globally.

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ntibiotic resistance is a global problem that requires global action, but the capacity for surveillance of antibiotic use and antibiotic resistant infections and stewardship in many low- and middle-income countries (LMICs) is low.

Antimicrobial stewardship – the responsible use of antibiotics to reduce inappropriate prescribing

– is essential in the global battle to tackle antibiotic resistance. An international survey of antimicrobial stewardship (AMS) programmes from 660 hospitals in 67 countries across six continents highlighted the positive impact of antimicrobial stewardships programmes.

Where programmes were evaluated, organisations reported that the programme was associated with reductions in inappropriate prescribing (96%); the use of broad spectrum antibiotics (86%); expenditure on antibiotics (80%); the incidence of healthcareacquired infections (71%); hospital

length of stay (65%) and bacterial resistance (58%) .

Supporting AMS initiatives globally Countries with well-established AMS programmes should have a key role in supporting the development of these programmes. However, it is important that programmes have thorough situational assessments and understanding of the behavioural drivers and context in each country (figure 1).

The UK is increasing its global support, including the PHE International Health Regulations (IHR)

strengthening programme, which provides technical support for AMR surveillance, guideline development and improving stewardship in LMICs partner countries; alongside supporting and strengthening their health systems, and compliance with the International Health Regulations.

In addition, a new Commonwealth Partnerships for AMS programme (CwPAMS) funded by the Fleming Fund (a UK aid programme in the Department of Health and Social Care) has been launched.

Over the next 20 months, the UK will leverage the expertise of UK health institutions as well as

infection and pharmacy experts to strengthen the capacity of the health workforce and institutions in four Commonwealth countries including Ghana, Tanzania and Uganda to develop AMS programmes. e-Book info: The free-to-access interactive e-Book on Antimicrobial Stewardship (e-BAS) by the British Society for Antimicrobial Chemotherapy is a useful global resource for those considering how start an AMS programme.

1: HOWARD, P. ET AL. AN INTERNATIONAL CROSS-SECTIONAL SURVEY OF ANTIMICROBIAL STEWARDSHIP PROGRAMMES IN HOSPITALS. J. ANTIMICROB. CHEMOTHER. 70, 1245–1255 (2015). 2: CWPAMS PROGRAMME IS LED BY THE TROPICAL HEALTH EDUCATION TRUST (THET) AND THE COMMONWEALTH PHARMACISTS’ ASSOCIATION (CPA) 3: HTTP://BSAC.ORG.UK/ANTIMICROBIAL-STEWARDSHIP-FROM-PRINCIPLES-TO-PRACTICE-E-BOOK/

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Tackling AMR: global solutions for a global challenge

There must be a one-health approach to antibiotics across the human and animal sectors

Dr Manica Balasegaram

Professor S Peter Borriello Chief

Executive Director, Global Antibiotic Research and Development Partnership (GARDP)

Chief Executive, Veterinary Medicines Directorate, Department for Environment, Food and Rural Affairs

Antibiotic resistance can affect anyone, of any age, in any country. It’s one of the biggest threats to global health, food security, and development today, and a barrier to achieving Sustainable Development Goal 3.

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orryingly, current treatments in development fail to address the biggest public health threats posed by increasingly drug-resistant GramNegative Bacteria – a point reiterated by the G20 health ministers at their very first meeting in 2017. The Declaration issued following this meeting welcomed initiatives, including GARDP, to ‘reinvigorate research and development (R&D) in science and industry for antimicrobials.’

Global collaborations on R&D The challenge of antibiotic R&D is not an easy one and it is crucial to bring actors together that complement each other. Global collaborations that include industry, academia and governments, for instance, can help ensure resources are optimised and that the right actors are brought in to accelerate product development.

Prioritising global health needs Taking a global perspective and developing treatments that reflect public health needs should be the starting point for all public investment.

Real-world, clinical context needs to be

considered when prioritising which treatments to focus on. This means developing antibiotics that target populations and indications of global significance, including those that will not be addressed by actors due to perceived risks, challenges and lack of commercial interest. Investment needs to focus on how to optimise use, access, and quality of both existing and new antibiotics. Astonishingly, more people currently die from lack of access than from resistance.

Addressing stewardship and access Of course, any effort to tackle AMR must address the complex issues of stewardship, ensuring access but not excess while reflecting the realities of clinical practice. Commitments need to go beyond vague promises. Some of the steps can include limiting indications of new treatments, improving formulations and drug profiles, and providing an evidence base to develop stewardship guidelines.

Sustainable investment in R&D What is clear is that a coordinated global effort is urgently needed as new and remaining actors in the antibiotic development landscape struggle to mobilise financial resources. Yes, we need sustainable investment in R&D, but this should be tied in closely to prioritising global public health needs, access and stewardship. We need a commitment from governments but also long-term funding from other sources to tackle AMR.

The need to conserve antibiotics so that they remain effective to treat infections is a responsibility shared by all professions and users. This cuts across human, animal and plant health in all parts of the world, which highlights the ‘one-health’ nature of the problem and the concerted and integrated requirement of the response.

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n simple terms, resistance to antibiotics is everybody’s problem and everybody’s responsibility to tackle. Although it is a shared responsibility, working together has been hampered by a lack of understanding between different professional users of antibiotics (for example human medicine and animal medicine) and differences in the ability between different parts of the world to engage their own populations about the threat of antibiotic resistance, to prioritise the issue and to bring resources to bear on the problem. Outreach and support is therefore essential.

The best way to prevent spread of antibiotic resistance is to export best antibiotic management and stewardship.

The principles underlying better stewardship of antibiotics – in all spheres of use – are common. So, those needed in animal health, particularly for food production, are primarily identical, and are the backbone of all national action plans.

Healthy, well-looked-after animals reduce the need for antibiotics in feed Healthier animals that are well looked after should be more resilient to infection and therefore get ill less often. This can be helped by vaccinating animals against certain infections. If they get ill less often, so the need to treat with antibiotics is reduced. This is now most commonly measured by recording total sales of antibiotics for animal use.

Even in the best systems, some animals will become ill. The issue then is to use the most appropriate antibiotics and where possible avoid those essential as last resort antibiotics for human medicine.

Better diagnostics are needed for early intervention Improved, rapid and cheap diagnostics would be a great enabler in informing whether an antibiotic is needed, and if so, which one of those allowed to be used would be most appropriate. There is commonality here with human medicine, particularly for diagnosis in the community. The need for cheap, reliable, robust, rapid and accurate diagnostics is a big challenge and one that should be explored in a onehealth context.

It’s a challenge to curb bacteria spreading Preventing the spread of bacteria, especially those that may have become resistant, is then a big challenge, particularly as most

animals being treated are in the wider environment. Understanding of the importance of the spread of resistance is poor and interventions are often based on assumptions.

Two key differences between human and animal medicine are the use of antibiotics in parts of the world for growth promotion of livestock, and the likelihood of novel antibiotics ever becoming available for treatment of animals (which is close to zero).

Human and animal antibiotics must have a conjoined approach There are more shared issues, practices and intervention principles between animal and human infections than there are differences. It is essential, therefore, that there is a closer, truly integrated engagement between the two.

Currently, one-health is characterised more as an afterthought or putting animal and human food data between the same covers of a report.

This is not one-health. It risks selfdelusion, and risks reducing the chance of finding ways through the problems.

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Superbugs call for drastic solutions to innovation Thomas Cueni Director General, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Chair, AMR Industry Alliance

By 2050, superbugs could cost the global economy up to 3.5% of GDP or $100 trillion – and push 28 million more people into poverty.

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ntimicrobial resistance (AMR) is on course to overtake cancer and account for 10 million deaths a year by 2050. Already, 700,000 people die from drug-resistant infections (“superbugs”) each year. AMR could cost the global economy up to $100 trillion – and push 28 million more people into poverty.

The life science industry – research-based, generics, biotech and diagnostic companies – is researching solutions to avoid medical progress being thrown back to the dark ages as AMR continues to undermine treatments for infectious diseases. A new coalition of over 100 such companies, the AMR Industry Alliance1, is uniquely collaborating in this fight.

Research is under pressure to ensure we are not thrown into the dark ages of AMR This involves preserving the efficacy of existing antibiotics and developing new ones. So far, AMR Industry Alliance says companies have invested at least $2 billion in 2016 in R&D to counter AMR. A 2017 report commissioned by the German government estimates that governments have given $500 million to R&D for new antibiotics. As of June 2018, four new antibiotic drug applications have been submitted and 42 new antibiotics with the potential to treat serious bacterial infections are in clinical development. But this is not enough. The report recommends the development of one new high-need antibiotic a year. This is a very big ask, given the fragility of the market and the lack of robust incentives.

Incentives for innovation Thankfully, a global consensus has emerged, agreeing that AMR requires concerted collaboration to provide incentives for innovation to achieve an impactful, long-term change on the pipeline of new products and strengthen patients’ access to the appropriate treatments.

Incentives are needed to overcome the challenge of high-risk investments that are difficult to sustain under the current conditions where new antibiotics will remain on the shelves as reserve and for use as a last resort, meaning there is very limited and unpredictable economic return on these products. Incentives can also address the problem that antibiotics are generally undervalued by reimbursement systems relative to the benefits they bring society.

Cutting-edge diagnostics for effective antibiotic use Diagnostics play a key role for the optimal diagnosis of a patient, for the optimal cost-efficient functioning of healthcare systems, and for the benefit of public health.

They guide the effective use of antibiotics by identifying the infectious agent, as well as any potential resistance to antibiotics, in order to help clinicians prescribe the most appropriate treatment with the shortest time delay. They also reduce inappropriate use while helping to ensure that existing drugs remain effective.

Diagnostics are crucial to implementing informative and effective AMR surveillance systems that collect and analyse important information on pathogen identification and resistance in countries or regions. Novel methods, such as molecular syndromic testing, can provide rapid and accurate results for many different pathogens all at the same time, maximising patient health outcomes, saving time and money and avoiding repeated testing. New diagnostics adapted to low- and middle-income countries are also urgently needed.

But, to accelerate effective innovation from biotechs, diagnostics firms and R&D pharma companies, governments need to implement new, alternative market structures that provide more dependable and sustainable market models. The present market is fragile so there is an urgent need to act.

Fundamental changes are needed to encourage R&D efforts towards novel diagnostics and therapeutics, to simplify and facilitate market access of innovative health products and to develop educational and communication programmes around AMR for health workers as well as the general public.

1: WWW.AMRINDUSTRYALLIANCE.ORG

AMR could decimate the Earth’s population; diagnostic tests can change that Doris-Ann Williams MBE Chief Executive, British In Vitro Diagnostics Association

Antimicrobial resistance has the potential to decimate the global population and poses an enormous threat to everyone on Earth. There are many examples of antibiotic overuse, which have allowed bacteria to develop resistance to the antibiotics by mutating. They have the ability to evolve rapidly to survive and thrive.

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uman health is a core example.

Health systems differ around the world, both in the use of antibiotics and how far healthcare is developed, and the extent to which the bacteria is causing infection in different geographical locations.

Humans can spread antimicrobial-resistant bacteria by travelling abroad Movement of people – as we travel by air, for example – exacerbates the problem, as antibiotic resistant infections can infect new populations of people.

Tuberculosis (TB) is an example of this and some of the different types of bacteria causing TB have become very strongly resistant to nearly all antibiotics, making treatment very difficult.

Detection of infection needs to be achieved as quickly and accurately as possible. In the developed world this must occur in both community and in hospital settings. There are a number of simple, rapid tests that should be more highly utilised to determine whether infection is caused by a virus or by bacteria, as only bacteria can be treated with antibiotics.

Antibiotics aren’t always the right medicine People naturally want to recover from coughs and colds as rapidly as possible, so a healthcare professional may prescribe a course of antibiotics.

But many of these coughs and colds will be due to a viral infection and so an antibiotic prescription is ineffective – having a test to demonstrate this will help family doctors explain this to patients.

Studies also show a significant number of physicians are likely to prescribe antibiotics to treat diarrhoea caused by rotavirus, due to the lack of capacity to establish a diagnosis.

The fear of poor treatment outcomes for critical diseases and to prevent widespread deaths, can lead doctors to resort to blind prescription of multiple and broad-spectrum antimicrobials, which further impacts on resistance by the organisms.

In a hospital setting, it is even more critical to treat patients rapidly and with the right antibiotic to prevent sepsis and other life-threatening infections from gaining hold in the body and spreading among the other, vulnerable in-patients. Laboratory tests are becoming more rapid and sensitive to allow this. Some tests look for specific genetic material from bacteria so enabling the most effective antibiotic to be used.

Basic healthcare systems require simple, accessible tests However, in many parts of the world, healthcare is much more basic than this and infection rates are already very high. People live in remote areas and

even where there are hospitals, these often do not have the same equipment and specialists to support the highest level of healthcare. So, diagnostic tests for these regions need to be simple, compact and rapid, easy to perform and without requiring electricity or a water supply. They also need to be cheap but safe and reliable! These are not easy requirements to meet as developing the tests and making the format meet these demands takes time and money.

How mobile phone tech and drones can reach remote areas Innovative uses of technology can deliver change in managing health, such as the use of mobile phone technology as one way of providing platforms for tests and managing results – even in remote regions – as huge numbers of these populations do have mobile phones. Another use of technology is to use drones to quickly deliver medical supplies – such as testing kits – where transport is an issue.

Funding is needed to ensure bacteria does not win the battle There is a variety of initiatives to provide funding sources to support test development as well as to produce more anti-bacterial treatments around the world, such as the Longitude Prize in the UK, but meanwhile it really remains a struggle to get more diagnostic tools and wider usage of existing diagnostic tests in the different healthcare settings before the resistance levels are such that bacteria win the battle.

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Can this new tech slow the progress of antibiotic resistance?

Decades of antibiotic overuse in healthcare and farming have led to a rapid rise in antibiotic resistance worldwide. Dr Natalie Whitfield, Director of Scientific and Medical Affairs at GenMark Diagnostics explains how new, rapid diagnostic technology can help fight this potential health crisis.

Dr Natalie Whitfield Director, Scientific and Medical Affairs GenMark Diagnostics

Described by the World Health Organization as ‘one of the biggest threats to global health, food security and development today’, antibiotic resistance occurs when bacteria change and become resistant to antibiotic medication, making it harder to treat the health problems that bacteria and fungi can cause.

that involve preventing infections and instigating antibiotic controls - are now vital in all healthcare settings.

“With approximately 20% of UK antibiotic prescriptions currently thought to be unnecessary1, improvements in the accuracy and speed of diagnosis when a patient is admitted to hospital can play a huge part in controlling the use of antibiotic medication,” says Dr Whitfield.

Appropriate antibiotic usage needs stewardship to prevent global problems

Earlier, more accurate detection will help identify which antibiotics are needed

With the number of deaths linked to antibiotic resistance set to rise to epidemic proportions worldwide if significant action isn’t taken now, antimicrobial stewardship programmes (ASP) - plans of action

Innovative, rapid molecular diagnostic systems like GenMark’s ePlex Blood Culture Identification panels could prove to be a game changer in these circumstances, as they can provide comprehensive

detection of infectious diseases from patients’ samples, often within a couple of hours - rather than the usual 24 to 36 hours needed for most conventional tests.

“These new, high-tech molecular diagnostic systems can also be used to understand specific strains of pathogens—for example by detecting which drug resistance genes they possess—and so which therapies should be avoided,” says Dr Whitfield.

Also valuable for speeding up diagnosis and treatment, GenMark has developed an additional software module for their ePlex system that they call Templated Comments. This capability empowers consultants, microbiologists, pharmacists and other specialists to translate their expertise and treatment suggestions directly onto the ePlex

result report and link to specific test results, which helps the hands-on clinician deliver the right clinical interventions, faster. “Templated Comments doesn’t just speed up time to effective therapy,” says Dr Whitfield. “It also helps ensure antibiotics are more accurately used, if indeed, they are needed at all.”

“Although these new tests may appear to be significantly more expensive to run, ultimately, they save hospitals and healthcare authorities money by helping to shorten hospital stays, reducing expensive antibiotic prescriptions, helping to control antibiotic resistance, and, studies2 show, saving more lives,” says Whitfield.

Results highlight trends for individual hospitals Finally, the information from these rapid diagnostic results can be used to improve antibiograms for individual hospitals. Antibiograms can be used to track changes in resistance patterns over time, informing the development of therapeutic guidelines, action plans and antibiotic stewardship programmes at the national, regional and local level.

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1: DAVIES, SC. (2018) REDUCING INAPPROPRIATE PRESCRIBING OF ANTIBIOTICS IN ENGLISH PRIMARY CARE: EVIDENCE AND OUTLOOK. J ANTIMICROB CHEMOTHER. 73(4): 833–834. 2: TIMBROOK, ET AL. (2017) THE EFFECT OF MOLECULAR RAPID DIAGNOSTIC TESTING ON CLINICAL OUTCOMES IN BLOODSTREAM INFECTIONS: A SYSTEMATIC REVIEW AND META-ANALYSIS. CLIN INFECT DIS. 64(1):15-23

CREDIT: GETTYIMAGES

Revolutionising sepsis diagnostics with results in under four hours Introducing a new class of product where all organisms in a whole blood sample can be put into a test, without which an early Gram result would not be possible.

A crucial, unmet need for sepsis diagnostics is the rapid determination if a bloodstream infection (BSI) is present or not and identifying the causative organisms and their antibiotic sensitivity pattern.

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he Gram stain result is of great value in clinical treatment of sepsis, despite the limited amount of information it provides, because it is the first lab test result provided to the clinician.

Saving time saves lives Faster results for septic patients have been reliably shown to reduce morbidity and mortality. Generally speaking, the sicker the patient, the greater the value of earlier targeting of antimicrobial therapy.

A study by Kumar et al. in patients with septic shock showed a 7.6% increase in mortality for each hour of delay in appropriate antimicrobial treatment.

results within one day, this is a vast improvement on the current standard of up to five days.

It is envisaged that this ruleout test, with its high negative predictive value of 99.5%, will have significant impact on reducing the use of unnecessary antibiotics. It will also have further benefits, such as helping to determine a patient’s suitability for discharge.

Results in under four hours Is it sepsis or not?

Our newly automated ETGA test is being piloted in studies at two different US sites, with a further site planned in the UK. With reportable

In a recent project co-funded by the UK’s innovation agency, Innovate UK, we have shown the feasibility of our new direct from blood test that will uniquely identify the presence

Dr Helen V Bennett Market Development Manager, Momentum Bioscience Ltd

or absence of a bacterial or fungal BSI, followed by the categorisation of the causative organisms as Gram positive, Gram negative or yeast, all in less than four hours.

Our rapid molecular Gram categorisation could enable earlier change of therapy; a switch from IV to oral, de-escalation or a switch to antifungals. It could also enable faster focus of antibiotics in unknown BSI cases. This new test may also help guide decisions to run more complex, expensive tests for identification and antimicrobial susceptibility. All of which helps towards improved patient management and overall cost

savings to the hospital.

None of the currently available rapid BSI diagnostics achieve this combination of determining presence or absence followed by Gram categorisation.

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