A partnership to fund the development of new treatments for severe bacterial infections in neonates under GARDP’s Neonatal Sepsis Programme

The overall purpose of GARDP’s neonatal sepsis programme is to develop up to three new or improved treatments for newborns with severe bacterial infections by 2023. The activities funded under this programme will make an important contribution towards achieving these objectives by prioritising three work packages with the following focus: 1. Improve clinical management of neonatal sepsis This work package includes three key activities: completion of the global observational study; commencing clinical programme to develop a treatment to be used in place of the current WHO recommended empiric treatment, ampicillin and gentamicin for neonatal sepsis, and conducting clinical and laboratory capability strengthening in support of the clinical programme. 2. Developing new and improved treatments for multi drug-resistant infections in neonates This work package will aim to develop an effective and safe treatment for confirmed or highly suspected MDR-GN pathogens, including K. pneumoniae, or Acinetobacter spp., that is affordable and adapted for use in neonates. 3. Accelerating regulatory approval and access in high burden LMICs Through this work package, GARDP will work with WHO, pharmaceutical companies and regulatory authorities to ensure the newly developed treatments are globally accessible and that they are not ‘lost’ to resistance within a few years after their introduction. To achieve this, GARDP, in partnership with the relevant partner(s), will develop regulatory, public health and market access (including supply and distribution) strategies for any treatments developed.