News

16

Oct, 2020

Penta co-cordinated project, c4c, publishes first peer reviewed publication

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The c4c project, co-coordinated by Penta together with Janssen, Bayer and the University of Liverpool, has had its first review, titled “European research networks to facilitate drug research in children”, published by the British Journal of Clinical Pharmacology.  We are proud to have the Penta_ID Network involved in such an impactful project as a speciality network.   This review discusses the need for a structured approach to drug development by establishing and utilizing research networks and infrastructure. The publication explores how research networks and infrastructure can address the unmet medical […]

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16

Oct, 2020

European research networks to facilitate drug research in children

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  Author: Mark A. Turner, Katharine Cheng, Saskia de Wildt, Heidrun Hildebrand, Sabah Attar, Paolo Rossi, Donato Bonifazi, Adriana Ceci, Joana Claverol, Begonya Nafria, Carlo Giaquinto Published in: British Journal of Clinical Pharmacology Abstract: Paediatric drug development faces several barriers. These include fragmentation of stakeholders and inconsistent processes during the conduct of research. This review summarises recent efforts to overcome these barriers in Europe. Two exemplar initiatives are described. The European Paediatric Translational Research Infrastructure facilitates preclinical research and other work that underpins clinical trials. conect4children facilitates the design and […]

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20

May, 2020

Clinical Trials Day

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Clinical Trials Day is a well-deserved ‘time out’ to recognize the people who conduct clinical trials and to say “thanks” for what they do every day to improve public health.

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21

Apr, 2020

An optimised dosing regimen versus a standard dosing regimen of vancomycin for the treatment of late onset sepsis due to Gram-positive microorganisms in neonates and infants aged less than 90 days (NeoVanc): study protocol for a randomised controlled trial

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Authors: Hill LF, Turner MA, Lutsar I, et al; NeoVanc Consortium. Published in: Trials. 2020;21(1):329 Background Vancomycin has been used in clinical practice for over 50 years; however, validated, pharmacokinetic (PK) data relating clinical outcomes to different dosing regimens in neonates are lacking. Coagulase negative staphylococci (CoNS) are the most commonly isolated organisms in neonatal, late–onset sepsis (LOS). Optimised use to maximise efficacy while minimising toxicity and resistance selection is imperative to ensure vancomycin‘s continued efficacy. Methods NeoVanc is a European, open-label, Phase IIb, randomised, controlled, non-inferiority trial comparing an optimised vancomycin regimen […]

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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 […]

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4

Apr, 2019

SMILE Clinical Trial: 100th Patient Enrolled

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The Penta-sponsored clinical trial SMILE has achieved a significant milestone by recruiting its 100th patient yesterday. The patient was enrolled at the Perinatal HIV Research Unit (PHRU) in Soweto, South Africa.  This is a wonderful result achieved through hard work and cooperation among the sites, the CTUs and the sponsor.

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