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 […]
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 […]
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.
A communication brief updating stakeholders on PREPARE activities related to this season’s influenza activity has recently been published.