Clinical trial marks key milestone in fight against antibiotic resistance

An international clinical trial, led by The University of Queensland, has been hailed a significant step forward in the global challenge of antibiotic resistance.

UQ researchers have led the first randomised trial across 6 countries to examine a new antibiotic, cefiderocol, in the treatment of life-threatening, drug-resistant infections.

Associate Professor Patrick Harris, of UQ’s Centre for Clinical Research, said the drug was found to be effective and safe in treating bloodstream infections.

“The study is the first randomised controlled trial to specifically examine use of cefiderocol in bloodstream infections and sepsis,’’ he said.

“With increasing global antimicrobial resistance, there is a need for the development of new antibiotics.’’

The World Health Organisation estimates antimicrobial resistance, including antibiotic resistance, caused 1.27 million deaths globally and contributed to 4.95 million more in 2019.

The trial monitored more than 500 patients with serious bloodstream infections, caused by gram negative bacilli (antibiotic resistant bacteria) in Malaysia, Singapore, Thailand, Turkey, Greece, and Australia where the Royal Brisbane and Women's Hospital was a lead site.

It found the cefiderocol demonstrated a comparable level of effectiveness compared to standard treatment.

“We found the drug is effective and safe to use, though its performance against bacteria that resists our most potent antibiotics remains uncertain and further investigation is needed,’’ Dr Harris said.

“This trial adds to the real-world evidence of how cefiderocol performs and gives guidance to clinicians about its use.’’

Honorary Professor David Paterson, of UQ’s Centre for Clinical Research (UQCCR), said the trial was a partnership with Japanese company Shionogi, and marked a major achievement in academic-industry trials.

“Infections with antibiotic-resistant bacteria cause a significant burden of disease worldwide,’’ Professor Paterson said.

“Antibiotic resistance is expensive to deal with, but UQCCR has shown we can deliver international trials at the fraction of the traditional cost, and lead trials that help address the global challenge of antibiotic resistance.

“Academic-industry partnerships such as this can deliver trials efficiently and answer critical clinical questions relevant for clinical practice.’’

Professor Paterson said the next step is an international clinical trial examining whether combining cefiderocol with other drugs will effectively target carbapenem-resistant strains – or bacteria that resists the strongest antibiotics.

The trial was supported by charity Henderson Foundation, Singapore’s National Medical Research Council, and National Health and Medical Research Council.

The research is published in The Lancet Infectious Diseases.