Shiloh
Editor, Senior Moderator
Source: https://www.cidrap.umn.edu/news-perspective/2022/03/stewardship-resistance-scan-mar-11-2022
Stewardship / Resistance Scan for Mar 11, 2022
Promising results for new antibiotic; Resistant Salmonella in retail meat
Filed Under:
Antimicrobial Stewardship; Foodborne Disease; Salmonella
Candidate antibiotic combo shows promise for resistant urinary infections
Venatorx Pharmaceuticals of Malvern, Pennsylvania, yesterday released promising data from a phase 3 trial of its investigational new drug for patients with complicated urinary tract infections (cUTIs).
The drug, cefepime-taniborbactam, combines a fourth-generation cephalosporin antibiotic with a beta-lactamase inhibitor and targets difficult-to-treat drug-resistant gram-negative bacteria, including carbapenem-resistant Enterobacterales and carbapenem-resistant Pseudomonas aeruginosa. It's been granted Qualified Infectious Disease Product and Fast Track designation by the US Food and Drug Administration (FDA).
In the randomized, double-blind phase 3 study, which included 661 patients, investigators found that cefepime-taniborbactam met the primary efficacy end point of statistical non-inferiority to meropenem in patients with cUTI, including acute pyelonephritis.
In the microbiologic intent-to-treat population at test of cure (TOC), composite microbiologic and clinical success occurred in 70% of patients treated with cefepime-taniborbactam and 58% of patients treated with meropenem (treatment difference, 11.9; 95% confidence interval [CI], 2.4 to 21.6). A prespecified superiority test demonstrated the statistical superiority of cefepime-taniborbactam for the composite end point at TOC.
Rates of treatment-emergent adverse events were 35.5% for cefepime-taniborbactam and 29.9% for meropenem, with serious events occurring in 2% and 1.8% of patients, respectively.
"These data demonstrate that cefepime-taniborbactam may represent a significant improvement over the standard of care and could support global health efforts to combat antibiotic-resistant infections," Venatorx President and CEO Christopher Burns, PhD, said in a company press release. "Cefepime-taniborbactam, if approved by the FDA, may offer a new treatment option for patients with infections caused by highly resistant bacteria, even those resistant to widely used carbapenem antibiotics."
Venatorx developed cefepime-taniborbactam with funding from the National Institutes of Health, the Department of Health and Human Services, the Biomedical Advanced Research and Development Authority, and Wellcome Trust. In 2020, the company announced an agreement with the Global Antibiotic Research and Development Partnership to accelerate development of and access to the drug for adult and pediatric populations.
The company says it plans to submit a New Drug Application to the FDA later this year.
Mar 10 Venatorx press release
Rising fluoroquinolone sales for food animals tied to resistant Salmonella
A review of data on fluoroquinolone sales for food-producing animals and isolates from retail meat samples found a link between rising fluoroquinolone sales and increased quinolone resistance in Salmonella, researchers reported today in the Journal of Global Antimicrobial Resistance.
In the study, researchers from Penn State and the Pennsylvania Department of Health analyzed FDA data on antimicrobial sales for food-producing animals from 2013 through 2018 and reviewed antibiotic susceptibility data from 4,138 nontyphoidal Salmonella (NTS) isolates from retail samples of chicken, ground turkey, ground beef, and pork chops. The samples were collected from 2009 through 2018 through the FDA's National Antimicrobial Resistance Monitoring System. The investigators used Pearson's correlation to examine the association.
After adjusting for the increase in beef and pork production, the researchers found that fluoroquinolone sales increased by 41.67% from 2013 to 2018, from 0.72 kilograms (kgs) per kg of meat production in 2013 to 1.02 in 2018. The prevalence of quinolone-resistant NTS from beef and pork samples increased from 0.62% in 2009 to 12.75% in 2018. The increase of quinolone-resistant isolates in retail meats since 2016 were mostly related to Salmonella Infantis and Salmonella Enteritidis.
The correlation between the annual percentage of quinolone-resistant NTS from beef and pork samples with the annual adjusted fluoroquinolones sales was 0.67 (n = 6, P = 0.1449).
NTS is a major cause of foodborne illness worldwide, and while most NTS infections are self-limiting, roughly 5% of infected people develop invasive infections, for which the quinolone antibiotic ciprofloxacin is a first-line treatment. Antibiotic-resistant NTS are associated with excess bloodstream infections, longer hospitalizations, higher healthcare costs, and increased mortality.
"Our results indicate a moderately positive correlation of the annual standardized fluoroquinolone sales with the annual prevalence of quinolone-resistant NTS in retail meats," the study authors write. "The results from our study emphasize the need for integrated surveillance to monitor trends in antimicrobial resistance and to detect emergence of clinically consequential pathogens in humans and food animals."
Mar 11 J Glob Antimicrob Resist study
Stewardship / Resistance Scan for Mar 11, 2022
Promising results for new antibiotic; Resistant Salmonella in retail meat
Filed Under:
Antimicrobial Stewardship; Foodborne Disease; Salmonella
Candidate antibiotic combo shows promise for resistant urinary infections
Venatorx Pharmaceuticals of Malvern, Pennsylvania, yesterday released promising data from a phase 3 trial of its investigational new drug for patients with complicated urinary tract infections (cUTIs).
The drug, cefepime-taniborbactam, combines a fourth-generation cephalosporin antibiotic with a beta-lactamase inhibitor and targets difficult-to-treat drug-resistant gram-negative bacteria, including carbapenem-resistant Enterobacterales and carbapenem-resistant Pseudomonas aeruginosa. It's been granted Qualified Infectious Disease Product and Fast Track designation by the US Food and Drug Administration (FDA).
In the randomized, double-blind phase 3 study, which included 661 patients, investigators found that cefepime-taniborbactam met the primary efficacy end point of statistical non-inferiority to meropenem in patients with cUTI, including acute pyelonephritis.
In the microbiologic intent-to-treat population at test of cure (TOC), composite microbiologic and clinical success occurred in 70% of patients treated with cefepime-taniborbactam and 58% of patients treated with meropenem (treatment difference, 11.9; 95% confidence interval [CI], 2.4 to 21.6). A prespecified superiority test demonstrated the statistical superiority of cefepime-taniborbactam for the composite end point at TOC.
Rates of treatment-emergent adverse events were 35.5% for cefepime-taniborbactam and 29.9% for meropenem, with serious events occurring in 2% and 1.8% of patients, respectively.
"These data demonstrate that cefepime-taniborbactam may represent a significant improvement over the standard of care and could support global health efforts to combat antibiotic-resistant infections," Venatorx President and CEO Christopher Burns, PhD, said in a company press release. "Cefepime-taniborbactam, if approved by the FDA, may offer a new treatment option for patients with infections caused by highly resistant bacteria, even those resistant to widely used carbapenem antibiotics."
Venatorx developed cefepime-taniborbactam with funding from the National Institutes of Health, the Department of Health and Human Services, the Biomedical Advanced Research and Development Authority, and Wellcome Trust. In 2020, the company announced an agreement with the Global Antibiotic Research and Development Partnership to accelerate development of and access to the drug for adult and pediatric populations.
The company says it plans to submit a New Drug Application to the FDA later this year.
Mar 10 Venatorx press release
Rising fluoroquinolone sales for food animals tied to resistant Salmonella
A review of data on fluoroquinolone sales for food-producing animals and isolates from retail meat samples found a link between rising fluoroquinolone sales and increased quinolone resistance in Salmonella, researchers reported today in the Journal of Global Antimicrobial Resistance.
In the study, researchers from Penn State and the Pennsylvania Department of Health analyzed FDA data on antimicrobial sales for food-producing animals from 2013 through 2018 and reviewed antibiotic susceptibility data from 4,138 nontyphoidal Salmonella (NTS) isolates from retail samples of chicken, ground turkey, ground beef, and pork chops. The samples were collected from 2009 through 2018 through the FDA's National Antimicrobial Resistance Monitoring System. The investigators used Pearson's correlation to examine the association.
After adjusting for the increase in beef and pork production, the researchers found that fluoroquinolone sales increased by 41.67% from 2013 to 2018, from 0.72 kilograms (kgs) per kg of meat production in 2013 to 1.02 in 2018. The prevalence of quinolone-resistant NTS from beef and pork samples increased from 0.62% in 2009 to 12.75% in 2018. The increase of quinolone-resistant isolates in retail meats since 2016 were mostly related to Salmonella Infantis and Salmonella Enteritidis.
The correlation between the annual percentage of quinolone-resistant NTS from beef and pork samples with the annual adjusted fluoroquinolones sales was 0.67 (n = 6, P = 0.1449).
NTS is a major cause of foodborne illness worldwide, and while most NTS infections are self-limiting, roughly 5% of infected people develop invasive infections, for which the quinolone antibiotic ciprofloxacin is a first-line treatment. Antibiotic-resistant NTS are associated with excess bloodstream infections, longer hospitalizations, higher healthcare costs, and increased mortality.
"Our results indicate a moderately positive correlation of the annual standardized fluoroquinolone sales with the annual prevalence of quinolone-resistant NTS in retail meats," the study authors write. "The results from our study emphasize the need for integrated surveillance to monitor trends in antimicrobial resistance and to detect emergence of clinically consequential pathogens in humans and food animals."
Mar 11 J Glob Antimicrob Resist study