Shiloh
Editor, Senior Moderator
Source: https://www.cidrap.umn.edu/news-perspective/2020/06/stewardship-resistance-scan-jun-02-2020
Stewardship / Resistance Scan for Jun 02, 2020
Nosocomial pneumonia antibiotic; Discharge antibiotic stewardship
Filed Under:
Antimicrobial Stewardship
Cefiderocol gets FDA approval for use in nosocomial pneumonia
Drug maker Shionogi & Co. of Osaka, Japan, announced yesterday that the US Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) and granted Priority Review designation for the use of cefiderocol to treat adults with nosocomial pneumonia.
Cefiderocol, sold under the brand name Fetroja, is a cephalosporin antibiotic with a novel mechanism of penetrating the tough outer membrane of gram-negative bacteria and the ability to overcome resistance mechanisms used by gram-negative pathogens to evade antibiotics. It was approved by the FDA for treatment of complicated urinary tract infections caused by gram-negative pathogens on Nov 12, 2019.
According to a company press release, the sNDA is based on results from a phase 3 study that showed cefiderocol met the primary endpoint of non-inferiority compared with high-dose extended-infusion meropenem in treatment of patients with healthcare-acquired and ventilator-associated pneumonia caused by gram-negative pathogens.
The results showed that 14 days after initiation of treatment, all-cause mortality in the modified intention-to-treat population was 12.4% for cefiderocol (18 of 145 patients) and 11.6% for meropenem (17/146).
The company said cefiderocol also met key secondary endpoints of clinical and microbiologic outcomes at test-of-cure and demonstrated no unexpected safety signals.
"We are committed to working with the FDA in order to bring Fetroja to more patients fighting these challenging and life-threatening Gram-negative infections as quickly as possible," said Akira Kato, PhD, president and CEO at Shionogi Inc., the company's US-based subsidiary.
Jun 1 Shionogi press release
Discharge stewardship linked to better antibiotic prescribing, study finds
Expanding an antimicrobial stewardship program (ASP) to ensure that hospital patients are discharged with appropriate therapy was associated with improvements in appropriate antibiotic prescribing and fewer days of antibiotic therapy at an Ohio hospital, researchers reported today in Infection Control & Hospital Epidemiology.
The study assessed the percentage of patients discharged on appropriate therapy before and after implementation of the discharge stewardship intervention, in which the discharge ASP pharmacist at Northeast Ohio Medical University reviewed patient medical records and anti-infective regimens and provided recommendations on antibiotic therapy to the medical team, if appropriate.
Other outcomes included antimicrobial days of therapy (DOT) and the percentage of readmissions of healthcare visits for treatment failure within 30 days. A total of 122 patients were included in the study, with 61 each in the pre-intervention and post-intervention groups.
Analysis of the two groups found that the percentage of appropriate therapy on discharge was 47.5% before the ASP expansion compared with 85.2% afterward (relative risk [RR], 0.28; 95% confidence interval [CI], 0.147 to 0.538; P < .001). In the post-intervention phase, 48 recommendations were made across 40 patients upon discharge, with an 81% acceptance rate. Recommendations included change in duration (44%), followed by discontinuation (17%), change in dose (14.5%), and change in drug (10%).
The average duration of therapy was 7.8 days in the post-intervention group, compared with 8.9 days in pre-intervention group (P = 0.079). Antimicrobial DOTs were also lower after the intervention than before (555 days vs 626.5 days, respectively). The total 30-day readmission rate was 19.7% in the pre-intervention group versus 11.5% in the post-intervention group (RR, 0.583; 95% CI, 0.246 to 1.38; P = 0.212), a difference not considered statistically significant.
"This project demonstrated that the expansion of an ASP significantly improved the rate of appropriate discharge anti-infective prescribing," the authors of the study write. "A larger patient population is necessary to fully describe the effect on readmissions, adverse events, and treatment failure. Time spent on ASP will also be useful to determine the real-world feasibility of expanding to a larger population."
Jun 2 Infect Control Hosp Epidemiol abstract
Stewardship / Resistance Scan for Jun 02, 2020
Nosocomial pneumonia antibiotic; Discharge antibiotic stewardship
Filed Under:
Antimicrobial Stewardship
Cefiderocol gets FDA approval for use in nosocomial pneumonia
Drug maker Shionogi & Co. of Osaka, Japan, announced yesterday that the US Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) and granted Priority Review designation for the use of cefiderocol to treat adults with nosocomial pneumonia.
Cefiderocol, sold under the brand name Fetroja, is a cephalosporin antibiotic with a novel mechanism of penetrating the tough outer membrane of gram-negative bacteria and the ability to overcome resistance mechanisms used by gram-negative pathogens to evade antibiotics. It was approved by the FDA for treatment of complicated urinary tract infections caused by gram-negative pathogens on Nov 12, 2019.
According to a company press release, the sNDA is based on results from a phase 3 study that showed cefiderocol met the primary endpoint of non-inferiority compared with high-dose extended-infusion meropenem in treatment of patients with healthcare-acquired and ventilator-associated pneumonia caused by gram-negative pathogens.
The results showed that 14 days after initiation of treatment, all-cause mortality in the modified intention-to-treat population was 12.4% for cefiderocol (18 of 145 patients) and 11.6% for meropenem (17/146).
The company said cefiderocol also met key secondary endpoints of clinical and microbiologic outcomes at test-of-cure and demonstrated no unexpected safety signals.
"We are committed to working with the FDA in order to bring Fetroja to more patients fighting these challenging and life-threatening Gram-negative infections as quickly as possible," said Akira Kato, PhD, president and CEO at Shionogi Inc., the company's US-based subsidiary.
Jun 1 Shionogi press release
Discharge stewardship linked to better antibiotic prescribing, study finds
Expanding an antimicrobial stewardship program (ASP) to ensure that hospital patients are discharged with appropriate therapy was associated with improvements in appropriate antibiotic prescribing and fewer days of antibiotic therapy at an Ohio hospital, researchers reported today in Infection Control & Hospital Epidemiology.
The study assessed the percentage of patients discharged on appropriate therapy before and after implementation of the discharge stewardship intervention, in which the discharge ASP pharmacist at Northeast Ohio Medical University reviewed patient medical records and anti-infective regimens and provided recommendations on antibiotic therapy to the medical team, if appropriate.
Other outcomes included antimicrobial days of therapy (DOT) and the percentage of readmissions of healthcare visits for treatment failure within 30 days. A total of 122 patients were included in the study, with 61 each in the pre-intervention and post-intervention groups.
Analysis of the two groups found that the percentage of appropriate therapy on discharge was 47.5% before the ASP expansion compared with 85.2% afterward (relative risk [RR], 0.28; 95% confidence interval [CI], 0.147 to 0.538; P < .001). In the post-intervention phase, 48 recommendations were made across 40 patients upon discharge, with an 81% acceptance rate. Recommendations included change in duration (44%), followed by discontinuation (17%), change in dose (14.5%), and change in drug (10%).
The average duration of therapy was 7.8 days in the post-intervention group, compared with 8.9 days in pre-intervention group (P = 0.079). Antimicrobial DOTs were also lower after the intervention than before (555 days vs 626.5 days, respectively). The total 30-day readmission rate was 19.7% in the pre-intervention group versus 11.5% in the post-intervention group (RR, 0.583; 95% CI, 0.246 to 1.38; P = 0.212), a difference not considered statistically significant.
"This project demonstrated that the expansion of an ASP significantly improved the rate of appropriate discharge anti-infective prescribing," the authors of the study write. "A larger patient population is necessary to fully describe the effect on readmissions, adverse events, and treatment failure. Time spent on ASP will also be useful to determine the real-world feasibility of expanding to a larger population."
Jun 2 Infect Control Hosp Epidemiol abstract