A meaningful step forward in newborn health in Ghana

A landmark clinical trial to evaluate life-saving antibiotic combinations for treating newborns with sepsis has started in Ghana.

The NeoSep1 clinical trial in Ghana began with the first baby recruited at Komfo Anokye Teaching Hospital (KATH) in Kumasi. The trial builds on ongoing work in Africa, where newborns have been enrolled in the trial in hospitals in South Africa and Kenya.

The overall goal is to identify one or more safe, effective and affordable antibiotic treatment regimens that could reduce the number of newborns dying from drug-resistant sepsis. The trial, led by the Global Antibiotic Research and Development Partnership (GARDP) and key partners, also aims to provide data to inform and potentially update World Health Organization, institutional and national treatment guidelines for neonatal sepsis.

The clinical trial aims to enrol 3,000 newborns by the end of 2028 across hospitals in South Africa, Kenya, Ghana and Uganda, as well as India, Vietnam, Pakistan, Malaysia and Bangladesh.

GARDP is proud to work alongside the dedicated researchers and site teams at Komfo Anokye Teaching Hospital and partners including Kumasi Centre for Collaborative Research in Tropical Medicine (KCCR), the Global Health and Infectious Diseases Group (GHID-KCCR), and Kwame Nkrumah University of Science and Technology, Kumasi.

Each year, up to three million newborns around the world develop neonatal sepsis, a life-threatening bloodstream infection that is especially common in Sub-Saharan Africa and Asia. In these regions, the burden is felt most acutely, as access to timely diagnosis and effective antibiotic treatment is often limited. In Africa alone, 250,000 newborn babies die from sepsis every year. The crisis is exacerbated as an increasing number of newborns develop infections that are caused by bacteria resistant to WHO-recommended antibiotic treatments.

NeoSep1 is sponsored by GARDP in collaboration with the Innovative Clinical Trials Unit at University College (formerly MRC CTU @UCL), London; City St George’s, University of London (CSG); and Penta.

The NeoSep1 trial also forms part of a five-year project by a consortium of African and European partners called SNIP-AFRICA. Funded by EDCTP3 and led by Penta – Child Health Research, the collaboration is working to improving treatment for severe newborn infections at hospitals in Africa.

QUOTES
“By bringing together leading institutions and researchers, the NeoSep1 trial strengthens our capacity to collectively define what effective care for newborns with sepsis should look like in our settings,” Professor John Amuasi, Principal Investigator, NeoSep1 Part 2 in Ghana.

“Neonatal sepsis remains a major cause of preventable newborn deaths across African hospitals. Strengthening evidence to improve diagnosis and targeted therapy in this high-burden population is critical to saving newborn lives,” Dr Joseph Bonney, Site Principal Investigator, NeoSep1 Part 2, Komfo Anokye Teaching Hospital (KATH), Kumasi, Ghana.

“Newborn babies are extremely vulnerable, and even minor infections can become life-threatening within hours. Identifying safe and effective antibiotic options is crucial for improving survival and giving every newborn the best possible start to life,” Dr Naana Wireko Brobby, Neonatologist, Komfo Anokye Teaching Hospital, Kumasi, Ghana

“We hope NeoSep1 will build local capacity in Ghana, empower clinicians with clearer guidance, and contribute to a global shift toward more effective and context-appropriate treatment options for babies everywhere,” Dr Anthony Afum-Adjei Awuah, Co-Study PI, NeoSep1 Part 2 in Ghana

GARDP
GARDP (the Global Antibiotic Research & Development Partnership) Foundation is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Commission, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. GARDP is registered under the legal name GARDP Foundation in Switzerland. www.gardp.org