Exeporfinium chloride (XF-73) nasal gel dosed over 24 hours prior to surgery significantly reduced Staphylococcus aureus nasal carriage in cardiac surgery patients: Safety and efficacy results from a randomized placebo-controlled phase 2 study

Abstract

We studied 83 cardiac-surgery patients with nasal S. aureus carriage who received 4 intranasal administrations of XF-73 nasal gel or placebo <24 hours before surgery. One hour before surgery, patients exhibited a S. aureus nasal carriage reduction of 2.5 log10 with XF-73 compared to 0.4 log10 CFU/mL for those who received placebo (95% CI, -2.7 to -1.5; P < .0001).

Conflict of interest statement

J.P.L., W.G.L., and W.R.W. are employed by Destiny Pharma. J.G.M. was formerly an employee of Destiny Pharma and was funded to attend the ECCMID 2021 conference. W.G.L. has stock and/or stock options in Destiny Pharma, and J.G.M. formerly held stock while he was an employee. A.D. received consultancy fees from Destiny Pharma for statistical consultancy and support for the present study. J.E.M. and M.S.F. received funding from the Sponsor to serve on the data monitoring committee for the present study in 2020 and 2021. R.K.C.M. has leadership roles on the Thoracic Surgery Directors Association Executive Committee and the STS Workforce on E-Learning.

Figures

Fig. 1.

Change in burden of nasal S. aureus before and after surgery. Note. CFU, colony-forming units; h, hour.

Fig. 2.

Percentage of patients with zero nasal S. aureus carriage or ≥2 log10 CFU/mL reduction. Note. CFU, colony-forming units; h, hour.