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

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!

15

Feb, 2019

NeoVanc: pivotal achievement of 200 participants enrolled in the study

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We are pleased to celebrate the milestone achievement of the randomisation of 200 participants in the NeoVanc project. Congratulations to all the NeoVanc team!

A special mention needs to be made on the great effort of investigators, co-investigators and all researchers at recruiting sites involved in this key study on the use of Vancomycin in paediatrics. We look forward to continuing our work together towards reaching the project target of 300 evaluable participants and we wish the NeoVanc team the best of luck!

Funded by the European Commission’s FP7 programme, NeoVanc involves 12 European partners and is coordinated by Penta.

13

Dec, 2017

NeoVanc 3rd Investigators meeting

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