Network building

Adequate Daclatasvir exposures in children 14-35 Kg with available adult formulations

2021

Authors: Cressey RT, Abbassi M, Lallemant M, Indolfi G, Al-Nahari M, Farid S, Easterbrook P, Penazzato M,  El-Sayed HM

Published in: CROI 2021

 

Abstract: World Health Organization 2018 guidelines recommend Sofosbuvir (SOF)/Daclatasvir (DCV) as a pangenotypic regimen for the treatment of adults with chronic HCV infection. SOF/DAC is widely available as low-cost generic formulation in low and middle-income countries (LMICs).

Tools for Healthcare Workers to measure Health Research Capacity Development at an Individual Level

2020

 

Author: Bilardi D, Rapa E, Bernays S, & Lang T

Published in: European Academy of Pediatric Societies

 

Background: Despite health research capacity development (HRCD) in low and middle-income countries (LMICs) being recognised as a critical element to overcoming global health challenges, insufficient actions have been taken to tackle major barriers to HRCD.

European research networks to facilitate drug research in children

2020

 

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.

Harmonisation preserves research resources

2020

Authors: Vasconcelos MK, Epalza C, Renk H, Tagarro A, Bielicki JA

Published in: Lancet Infect Dis. 2020;24

In their Comment, the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) clinical characterisation group outline how harmonisation of clinical characterisation studies is achieved through their collaborative resource-sharing and data-sharing platform. We fully agree with both the importance of international harmonisation and the authors’

Respiratory pathogens detected in children with community-acquired sepsis-like syndrome in 6 European countries

2020

Authors: V. Matheeussen, K. Loens, K. Jacobs, P. Horby, H. Goossens, M. Kohns Vasconcelos, M. Sharland, M. De Jong, M. P. G. Koopmans, P. Fraaij, M. Ieven

Published in: 30th European Congress on Clinical Microbiology and Infectious Diseases (ECCMID), April 2020

Background: The management of infants admitted to hospital with sepsis-like syndrome (SLS) without apparent focus remains challenging.

Aetiology and outcome of children hospitalised for acute respiratory tract infections in Europe: findings from a multi-country combined case-control and cohort study

2020

Authors: M. Kohns Vasconcelos; on behalf of the PED-MERMAIDS Study Group

Published in: 30th European Congress on Clinical Microbiology and Infectious Diseases (ECCMID), April 2020

Background: Recently, major aetiology and outcome studies on paediatric acute respiratory tract infections (ARI) have been reported from LMICs. In contrast, studies using standardised protocols across Europe are lacking.

Non-inferiority double-blind randomised controlled trial comparing gabapentin versus tramadol for the treatment of chronic neuropathic or mixed pain in children and adolescents: the GABA-1 trial-a study protocol

2019

Authors: Kaguelidou F, Le Roux E, Mangiarini L, et al.; GAPP consortium

Published in: BMJ Open. 2019;9(2):e023296

Introduction Gabapentin is currently used ‘off-label’ in children and adolescents with chronic neuropathic pain, and reliable evidence of its effects and optimal dosing are lacking.

Objectives The GABA-1 trial aims to compare the efficacy and safety of gabapentin liquid formulation relative to tramadol and to explore the pharmacokinetics of both drugs in the treatment of chronic,

Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years – evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial

2019

Authors: de Leeuw TG, Mangiarini L, Lundin R, et al; GAPP consortium

Published in: Trials. 2019; 20(1):368

Background Gabapentin has shown efficacy in the treatment of chronic neuropathic or mixed pain in adults. Although pediatric pain specialists have extensive experience with gabapentin for the treatment of neuropathic pain, its use is off-label. Its efficacy and safety in this context have never been shown.

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