The Global Antibiotic Research and Development Partnership (GARDP) and InfectoPharm are partnering to develop improved treatment options, using combinations of existing antibiotics, for neonatal sepsis, a leading cause of death and disability in newborns up to 28 days old. Since children of this age do not have a functioning immune system, they are more prone to developing infections and less able to overcome them.
Up to 40 percent of bacterial infections in hospitalized newborns are resistant to standard treatments, leading to an estimated 214,000 newborn deaths each year from drug-resistant infections. Most of these deaths occur in resource-constrained countries and could be reduced through the availability of effective antibiotics.
“We are excited to partner with InfectoPharm to develop an improved combination therapy for neonatal sepsis, which is becoming increasingly resistant to current recommended treatments,” said Sally Ellis, Children’s Antibiotics Project Leader at GARDP. “Given that antibiotic resistance is a growing threat and antibiotics to treat drug-resistant infections in children are extremely limited, there is an urgent need to develop new and improved treatments for serious bacterial infections in children and newborns.”
GARDP has successfully identified three existing antibiotics – fosfomycin, flomoxef and amikacin – as potential alternative treatments to ampicillin-gentamicin, the current WHO recommended treatment for clinically diagnosed sepsis in newborns.
GARDP completed a small study to confirm the correct dose and safety of i.v. fosfomycin to treat premature and newborn babies with neonatal sepsis. The active ingredient fosfomycin is already being used successfully worldwide in the fight against resistant and multi-resistant germs. InfectoPharm Arzneimittel und Consilium GmbH is committed to working with GARDP by supporting the study through the provision of one of the study medication, fosfomycin, known in Germany as InfectoFos® and Fomicyt® in other European countries.
“Alternative antibiotic combinations to ampicillin and gentamicin are urgently needed for use in settings with high levels of drug-resistant infections,” said Dr. Markus Rudolph, Managing Director of InfectoPharm. “We hope that this study will ultimately provide the evidence to allow WHO to update their treatment guidelines for neonatal sepsis.”
GARDP and InfectoPharm are committed to closing medical data gaps by using existing antibiotic combinations to develop potential new treatments for neonatal sepsis. The new data will be provided to WHO to review and formulate future treatment recommendations for neonatal sepsis. It will ultimately provide low-middle income countries, who are increasingly unable to use current recommended neonatal sepsis treatments due to antibiotic resistance, with access to effective and safe antibiotics.
The Global Antibiotic Research and Development Partnership (GARDP) is a Swiss not-for-profit organization developing new treatments for drug-resistant infections that pose the greatest threat to health. GARDP was created by the World Health Organization (WHO) and the Drugs for Neglected Diseases initiative (DNDi) in 2016 to ensure that everyone who needs antibiotics receives effective and affordable treatment. We aim to develop five new treatments by 2025 to fight drug-resistant infections. GARDP is funded by the governments of Germany, Japan, Luxembourg, Monaco, Netherlands, South Africa, Switzerland, United Kingdom, as well as Médecins Sans Frontières and private foundations.
InfectoPharm Arzneimittel und Consilium GmbH specializes in the further development of medicines for children. For over 30 years, this family-run German company has distinguished itself as a groundbreaking pioneer in the industry. The portfolio currently comprises around 130 preparations with numerous innovations in the fields of pediatrics, infectious diseases, pneumology, dermatology and allergology, which are increasingly attracting international attention. The consilium service is available free of charge to professionals as a product-neutral consulting and knowledge transfer service. InfectoPharm employs more than 200 people at its headquarters in Heppenheim, south of Frankfurt, Germany.