Antimicrobial

The European Medicines Agency (EMA) has published the final revised guideline on the evaluation of human medicines for the treatment of bacterial infections.

The revised guideline reflects the outcome of recent discussions between regulators in the EU, United States and Japan on the development of new antimicrobial medicines. Among others, it includes recommendations on the clinical criteria for patient enrolment, the primary endpoint and the primary analysis in infection site-specific trials.

Louise Hill presented the findings of a NeoVanc sub-study at ESPID’s 2020 Virtual Meeting in late October. Below is a summary of the study and findings.

Enterococcus (a bacterium) and candida (a fungus) can sometimes be found on or in the human body.  Occasionally enterococci can develop resistance to one of the antibiotics usually used to treat it – vancomycin.

Vancomycin use has been linked to a rise in vancomycin-resistant enterococci and candida on or in the bodies of babies admitted to the neonatal intensive care unit.

The second trial in neonatal sepsis sponsored by Penta is now in its final stretch towards completion. This trial is part of the NeoVanc project, which aimed to analyze the adaptability of an off-label medicine, vancomycin, to the specific needs of neonates and infants, by developing an optimal dosing regimen. Coordinated by Penta and funded by the European Commission’s 7th Framework Programme, NeoVanc has successfully recruited almost 250 participants, and involved more than 20 sites in 5 European countries.