Cefiderocol versus high-dose, extended-infusion meropenem for the treatment of Gram-negative nosocomial pneumonia (APEKS-NP): a randomised, double-blind, phase 3, non-inferiority trial

RCT (n=300) reports cefiderocol was non-inferior to high-dose, extended-infusion meropenem in terms of all-cause mortality on day 14 in this population; 12.4% vs. 11.6%, respectively (adjusted treatment difference 0.8%, 95% CI −6.6 to 8.2; p=0.002 for non-inferiority).

SPS commentary:

Authors’ of a related commentary state the global public health crisis of multidrug-resistant Gram-negative organisms underscores the need for antibiotics with novel bacterial targets such as cefiderocol, the first siderophore-conjugated antibiotic; and results of this study suggest that cefiderocol is a potential option for the treatment of patients with nosocomial pneumonia, including those caused by multidrug-resistant Gram-negative bacteria. This commentary also discusses results of a related study published in the same issue (CREDIBLE-CR); which showed cefiderocol had similar clinical and microbiological efficacy to best available therapy in patients with serious infections caused by carbapenem-resistant Gram-negative bacteria.

Cefiderocol is licenced in the UK for treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.

The Lancet Infectious Diseases

Resource links:

Commentary

CREDIBLE-CR study