Publications

10

Jan, 2020

Implementation and impact of pediatric antimicrobial stewardship programs: a systematic scoping review

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Authors: Donà D, Barbieri E, Daverio M, Lundin R, Giaquinto C, Zaoutis T, Sharland M

Published in: Antimicrob Resist Infect Control.2020;9:3

Background Antibiotics are the most common medicines prescribed to children in hospitals and the community, with a high proportion of potentially inappropriate use. Antibiotic misuse increases the risk of toxicity, raises healthcare costs, and selection of resistance. The primary aim of this systematic review is to summarize the current state of evidence of the implementation and outcomes of pediatric antimicrobial stewardship programs (ASPs) globally.

Methods MEDLINE, Embase and Cochrane Library databases were systematically searched to identify studies reporting on ASP in children aged 0-18 years and conducted in outpatient or in-hospital settings. Three investigators independently reviewed identified articles for inclusion and extracted relevant data.

Results Of the 41,916 studies screened, 113 were eligible for inclusion in this study. Most of the studies originated in the USA (52.2%), while a minority were conducted in Europe (24.7%) or Asia (17.7%). Seventy-four (65.5%) studies used a before-and-after design, and sixteen (14.1%) were randomized trials. The majority (81.4%) described in-hospital ASPs with half of interventions in mixed pediatric wards and ten (8.8%) in emergency departments. Only sixteen (14.1%) studies focused on the costs of ASPs. Almost all the studies (79.6%) showed a significant reduction in inappropriate prescriptions. Compliance after ASP implementation increased. Sixteen of the included studies quantified cost savings related to the intervention with most of the decreases due to lower rates of drug administration. Seven studies showed an increased susceptibility of the bacteria analysed with a decrease in extended spectrum beta-lactamase producers E. coli and K. pneumoniae; a reduction in the rate of P. aeruginosa carbapenem resistance subsequent to an observed reduction in the rate of antimicrobial days of therapy; and, in two studies set in outpatient setting, an increase in erythromycin-sensitive S. pyogenes following a reduction in the use of macrolides.

Conclusions Pediatric ASPs have a significant impact on the reduction of targeted and empiric antibiotic use, healthcare costs, and antimicrobial resistance in both inpatient and outpatient settings. Pediatric ASPs are now widely implemented in the USA, but considerable further adaptation is required to facilitate their uptake in Europe, Asia, Latin America and Africa.

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30

Dec, 2019

Standardising neonatal and pediatric anitibiotic clinical trial design and conduct: the PENTA-ID network review

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Authors: Folgori L, Lutsar I, Standing JF, et al.

Published in: BMJ Open. 2019; 9:e032592

Abstract: Antimicrobial development for children remains challenging due to multiple barriers to conducting randomised clinical trials (CTs). There is currently considerable heterogeneity in the design and conduct of paediatric antibiotic studies, hampering comparison and meta-analytic approaches. The board of the European networks for paediatric research at the European Medicines Agency (EMA), in collaboration with the Paediatric European Network for Treatments of AIDS-Infectious Diseases network (www.penta-id.org), recently developed a Working Group on paediatric antibiotic CT design, involving academic, regulatory and industry representatives. The evidence base for any specific criteria for the design and conduct of efficacy and safety antibiotic trials for children is very limited and will evolve over time as further studies are conducted. The suggestions being put forward here are based on the adult EMA guidance, adapted for neonates and children. In particular, this document provides suggested guidance on the general principles of harmonisation between regulatory and strategic trials, including (1) standardised key inclusion/exclusion criteria and widely applicable outcome measures for specific clinical infectious syndromes (CIS) to be used in CTs on efficacy of antibiotic in children; (2) key components of safety that should be reported in paediatric antibiotic CTs; (3) standardised sample sizes for safety studies. Summarising views from a range of key stakeholders, specific criteria for the design and conduct of efficacy and safety antibiotic trials in specific CIS for children have been suggested. The recommended criteria are intended to be applicable to both regulatory and clinical investigator-led strategic trials and could be the basis for harmonisation in the design and conduct of CTs on antibiotics in children. The next step is further discussion internationally with investigators, paediatric CTs networks and regulators.
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18

Nov, 2019

European Antibiotic Awareness Day

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Today, 18th of November, is European Antibiotic Awareness Day (EADD), that marks the start of the World Antibiotic Awareness Week (WAAW). WAAW aims to increase global awareness of antibiotic resistance, as well as  encourage best practices among the general public, health workers and policy makers to stop the spread of antibiotic resistance. The latest data from the European Centre for Disease Prevention and Control highlights that across the European Union, the number of patients infected by resistant bacteria is increasing. Emphasising the major threat antibiotic resistance continues to pose to public health. Infections caused by antibiotic resistant bacteria can be life-threatening, especially for those most vulnerable in society, such as children and especially newborns. However, until recently, the increasing trend in drug-resistant infections in infants and children has gone relatively unrecognized. In the last few years Penta has been involved in several European and global initiatives aimed at better characterising the use of antibiotics in children and infants, understanding the scale of resistance and investigating the best treatment regimens. At Penta, we are continuing to actively expand our activities in this important area and accelerate the development of treatments for infants and children. #KeepAntibioticsWorking #WakeUpToAMR

2

Oct, 2019

A look back at European Researchers’ Night

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Bacteria are steadily becoming less and less responsive to currently available antibiotics. Together with members of the public, we explored the hot topic of ‘antimicrobial resistance’ at the European Researchers’ Night on 27 September 2019 in Padua, Italy. Every year in the EU alone, an estimated 33,000 people die as a result of infections that cannot be treated with antimicrobial drugs. Sure enough, the World Health Organization (WHO) has placed the growth of antimicrobial resistance on its list of top five threats to global health in 2019.

A total of 57 people took part in the interactive WHO online survey, and the results proved eye-opening! 21% of respondents believed that antibiotics were effective against viruses or all microorganisms. Meanwhile, only one third of people interviewed knew that the overuse of antibiotics leads to higher levels of resistance in microbes, and not in the human body itself.

 

 

It’s clear there is still much work to be done to fill the knowledge gaps on this critical issue. Scientific and academic institutions need to continue strengthening their efforts to make people aware that every one of us is responsible for halting the rise in antimicrobial resistance. Wash your hands properly, always seek for medical advice before taking an antibiotic and remember that drug resistance is becoming a problem not only in people, but also in animals, especially those used for food production, as well as in the environment. Without the proper action today, there will be no cure tomorrow!

27

Sep, 2019

Let’s talk about antimicrobial resistance: Penta at European Researchers’ Night

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Penta will be at the European Researchers’ Night in Padua on 27 September, 2019. For this edition we have chosen the theme of ‘antimicrobial resistance’ (AMR). With the help of flyers and an educational video we hope to illustrate to the public what ‘AMR’ is, how it develops and spreads, and raise awareness on how much this problem is threatening global health. Our team will point out some simple yet extremely important practices that can help limit the rise of resistance.

Antimicrobials are one of the most important fields of activity for Penta; we are involved in several European and global initiatives aimed at better characterizing the use of antibiotics among children and neonates, the scale of resistance in this population and at investigating optimal treatment regimens for common neonatal infections.

The European Researchers’ Night is an initiative that, since 2005, has brought together researchers and the general public in different European cities on the same date in late summer: the fourth Friday in September. The event is a unique opportunity to invite the public to explore the world of research, to open a space for meeting and starting a dialogue with citizens and to encourage young people to pursue scientific careers. People of all ages will have the opportunity to visit research facilities that are usually not open to the public, use the latest technologies with the guidance of researchers, participate in experiments, competitions, demonstrations and simulations, exchange ideas and, most of all, have fun!

25

Sep, 2019

Uniting against antibiotic resistance: ‘5 by 25’

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Our friends at GARDP are calling upon the global community to support its goal to develop and deliver five new treatments by 2025 in response to the growing burden of antibiotic resistant infections.

Antibiotics have radically transformed our world by making previously incurable illnesses treatable. As a result, not only has our wellbeing significantly improved, but millions of lives have been saved. However, this remarkable progress is threatened by the spread of antibiotic resistance and requires an urgent global response.

We need solutions that will deliver for global public health. No one country or sector can do it alone. The GARDP model of public-private partnerships is key to preventing the world form entering a post-antibiotic era. Only together can we tackle this impending crisis!

GARDP invite you to join them at this year’s World Health Summit in Berlin to learn how their ‘5 BY 25’ goal will accelerate the development and delivery of five new and improved treatments to address antibiotic-resistant infections that pose the greatest threat to health and development. These new treatments will focus on the priority pathogens identified by the World Health Organization, and current unmet needs for diseases and key populations.

If you are interested in attending please write to ‘contact@gardp.org‘ by 17 October 2019.

 

Event details:

Date: Monday 28 October, 2019
Time: 14.00 –15:30
Venue: Saal 2 – America, Kosmos, Karl-Marx-Allee 131a, Berlin, Germany

28

May, 2019

Article – “R&D for children’s antibiotics: a wake-up call” published in AMR Control

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We are delighted to see an article on children’s antibiotics, co-authored by GARDP R&D Director, Dr Seamus O’Brien, Penta’s Chief Scientific Officer, Prof. Theo Zakoutlis and Prof. Mike Sharland, from St. George’s, University of London, published in AMR Control, as governments have been discussing AMR at the World Health Assembly.

In R&D for children’s antibiotics: a wake-up call the authors explain how AMR has a disproportionate effect on children, jeopardizing the attainment of the Sustainable Development Goals and universal health coverage. The article highlights research that must serve as an urgent wake-up call. This includes a study showing how, in Europe, infants under the age of 1-year-old bear the highest burden of AMR and a study which finds an estimated 214,000 neonatal sepsis deaths a year result from drug-resistant infections.

It outlines how children, particularly babies and young infants, need medicines that are adapted in terms of dosing, formulation. Yet, how lack of evidence means that such treatments are often simply not available. It reviews how the very few active clinical trials are limited in scope, do not recruit enough patients and do not focus on the most life-threatening infections.

The authors then highlight the work the partners are doing together – including the development of a global children’s antibiotic platform, which aims to accelerate paediatric development of antibiotic treatments, including clinical trials designed to meet regulatory requirements, and also trials to inform treatment guidelines. It also links to wider initiatives such as conect4children and the European Clinical Research Alliance on Infectious Diseases (ECRAID), for which Penta is paediatric partner.

GARDP, Penta, and St George’s call upon governments, researchers, industry – anyone with an interest in tackling AMR in children – to join them.

Read the full article here!

17

May, 2019

Infection Prevention in Paediatrics: ‘Hand in Hand’ – working together for children

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On Tuesday 24th September, the Infection Prevention Disease Society event IP2019 in Liverpool will host the one-day conference: Infection Prevention in Paediatrics: ‘Hand in Hand’- working together for children.

This important event will address paediatric care across areas such as Infection Prevention & Control, Tissue Viability & Wound Care, IV and Infectious Diseases. The programme has been tailored towards all paediatric healthcare workers including: IV Specialist Nurses, ICNs, Tissue Viability Nurses, IPC Link Nurses and Infectious Disease Specialists.

The theme of the conference closely ties in with the goals of the Penta supported project RANIN-KIDS, which aims to achieve optimal clinical outcomes among paediatric patients in Europe by fighting healthcare-acquired infections and reducing the inappropriate use of antibiotics.

Find out more about the programme and how to register here!

4

Mar, 2019

GARDP and Penta partner to accelerate the development of children’s antibiotics to tackle AMR

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Penta have joined forces with GARDP (The Global Antibiotic Research & Development Partnership) to tackle drug-resistant infections in children. Our strategic collaboration aims to accelerate paediatric development of antibiotic treatments including: clinical trials designed to meet regulatory requirements; and trials with a focus on public health interventions to inform treatment guidelines.

Globally, more than three million childhood deaths result from infectious diseases, such as pneumonia and sepsis. Children are also particularly affected by antimicrobial resistance (AMR). In Europe, a recent study found that infants under one-year-old bear the highest burden of drug-resistant infections, with a major impact on health, economy and society. The impact is expected to be even more severe in many low and middle-income countries.

“Ending unnecessary childhood deaths is a global health priority” said Dr Manica Balasegaram, Executive Director, GARDP. “Yet, severe lack of evidence is preventing the development of child-appropriate antibiotics for the treatment of drug-resistant infections. In response to this urgent global public health need, GARDP and Penta have embarked on a joint mission to develop and deliver accessible antibiotic treatments to tackle serious bacterial infections in children.”

Tackling AMR and its effects on children is critical to the attainment of the Sustainable Development Goals (SDGs), in particular the children’s health targets under SDG 3, which aims to ensure healthy lives and promote wellbeing for all. Prioritising the development of child-friendly antibiotics is an essential component of this.

Children, particularly babies and infants, need medicines that are adapted to their specific needs. Scarce evidence means child-friendly antibiotic treatment options are often limited, with paediatric evaluation of antibiotics only happening years after treatments are registered for use in adults.

GARDP and Penta’s partnership consolidates plans to help overcome this gap through the development of a global children’s antibiotic platform. Building on Penta’s international network of clinical trial sites and paediatric experts, the platform objectives include to: develop streamlined paediatric development plans acceptable to regulatory authorities; accelerate regulatory approval of treatments by ensuring children’s trials are started as early as possible; and incorporate innovative designs to maximise the information that can be gained from each trial.

Clinical trials in children involve highly complex ethical, regulatory and study-design issuessaid Carlo Giaquinto. “This partnership consolidates existing efforts between GARDP and Penta, allowing us to maximise our expertise in the fields of paediatric treatments and AMR, including Penta’s strong partnership with the Medical Research Council’s Clinical Trial Unit in London. 

“The knowledge created can help public health and industry partners to efficiently design and conduct their paediatric plans. This will speed-up access to antibiotics and facilitate the dissemination and routine implementation of global treatment guidelines”.

GARDP and Penta have established strong relationships with academic and/or government institutions from across Asia, Africa, Europe and South America. Partnerships with countries including Kenya, Greece, India, South Africa and Thailand underpin recent GARDP and Penta collaborations. These include apharmacokinetic clinical trial in Kenya, to assess safety and dosing of the antibiotic fosfomycin in new-borns, which recently completed enrolment; and a large-scale global observational study on neonatal sepsis, collecting clinical information in up to 3,000 new-borns in 19 hospitals in 11 countries.

Such engagement from countries worldwide, will be critical to the success of the platform and its trial networks.

Country partnerships are critical for the children’s antibiotic platform to flourish and reach its full potential” concluded Dr Balasegaram. “GARDP and Penta call on governments worldwide, as well as academics, donors, maternal child health organizations, public institutions, the private sector, scientists and more, anyone with an interest in overcoming AMR in children – to join us.”

A briefing note with further background on the need for children’s antibiotics and the partnership is available here.

 

About GARDP

GARDP is a not-for-profit R&D organization that addresses global public health needs by developing and delivering new or improved antibiotic treatments, while endeavouring to ensure their sustainable access. Initiated by the WHO and the Drugs for Neglected Disease initiative (DNDi), GARDP is an important element of WHO’s Global Action Plan on Antimicrobial Resistance that calls for new public-private partnerships to encourage R&D of new antimicrobial agents and diagnostics. GARDP’s programmes on sexually-transmitted infections, neonatal sepsis, paediatric antibiotics and antimicrobial memory recovery, evaluation and exploratory research are designed to address global public health priorities. Projects include the sponsoring of a phase III clinical trial for a novel, first-in-class oral antibiotic to treat drug-resistant gonorrhoea.

27

Feb, 2019

Penta representative makes first-time visits to neonatal units in Brazil

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Penta project manager Davide Bilardi, together with other NeoObs project partners, recently visited the neonatal units of the Santa Casa Hospital in São Paolo and the Clinical Research Unit of University of São Paolo in Ribeirao Preto. The visit occurred in the last week of January and was an opportunity to strengthen the relationship with new partner sites involved in the activities of this study. NeoObs is an observational study focused on understanding sepsis in newborns and current antibiotic prescribing practices. This project is part of the Global Antibiotic Research and Development Partnership’s (GARDP’s) broader programme to develop new and improved antibiotic treatments for children and newborns and, in addition to Brazil, involves hospitals in Bangladesh, China, India, Kenya, South Africa, Uganda, Italy, Vietnam, Thailand and Greece.