FDA approves Merck's combination antibacterial
The US Food and Drug Administration (FDA) today announced the approval of Recarbrio, a new three-drug antibacterial product developed by Merck, for treating patients with complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs) caused by gram-negative pathogens.
The injectable drug, a combination of the previously FDA-approved antibiotic imipenem-cilastatin and the novel beta-lactamase inhibitor relebactam, was approved for use in adults who have limited or no treatment options available, the FDA said in a press release.
"The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections," said Ed Cox, MD, MPH, director for the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient's infection."
Approval was based on efficacy data from a trial of imipenem-cilastatin for treatment of cUTIs and cIAIs, and on in vitro and animal-infection model studies that examined the contribution of relebactam, which protects imipenem from degradation by beta-lactamases. The safety was assessed in two trials: a cUTI trial in which 99 of 298 patients were treated with Recarbrio, and a cIAI trial in which 117 of 347 patients were treated with the drug.
The most common side effects reported were nausea, diarrhea, headache, fever, and increased liver enzymes.
A press release from Merck notes that Recarbrio should only be used to treat infections that are proven or suspected to be caused by susceptible bacteria.
Jul 17 FDA press release
Jul 17 Merck press release
Scientists identify potential new Candida auris clade
A team of Dutch, Iranian, and US scientists have identified a potential fifth clade of the multidrug-resistant fungus Candida auris, according to a letter published yesterday in Emerging Infectious Diseases.
The discovery was based on the results of whole-genome sequencing conducted on an isolate from a 14-year-old Iranian girl diagnosed with a C auris infection in her ear. The case, diagnosed in 2018, was the first known C auris infection in Iran, and the patient was reported to have never traveled outside of the country. The isolate was susceptible to the three major classes of antifungal drugs.
Comparison with 74 C auris isolates from other countries confirmed that the isolate was genetically distinct from the four other identified clades (commonly referred to as the South Asian, East Asian, African, and South American clades). Isolates from the East Asian clade were closest genetically.
To date, all of the isolates analyzed from more than 35 countries where C auris cases have been reported have clustered in the four clades.
"Ultimately, our discovery is a reminder that much about C. auris remains to be learned and underscores the need for vigilance in areas where C. auris has not yet emerged," the scientists write.
Jul 16 Emerg Infect Dis research letter
Pharmacist review linked to lower antibiotic use in French hospitals
An analysis of nationwide hospital data in France has found that antibiotic consumption was lower in hospitals where the antibiotic advisor was a pharmacist, and a pharmaceutical team reviewed all prescriptions, French researchers reported yesterday in the Journal of Global Antimicrobial Resistance.
For the retrospective observational study, researchers analyzed 2016 data from 77 hospitals involved in the French antibiotic consumption surveillance network. In addition to antibiotic consumption data, they also looked at antimicrobial stewardship (AMS) measures, pharmacist-specific actions, and use of a computerized prescription order entry (CPOE) system. Associations between antibiotic consumption and stewardship measures were assessed using linear regression.
The analysis found that pharmacists were involved in AMS programs in 73% of hospitals and served as the antibiotic advisor in 25%. Univariable analysis identified CPOE use (P = 0.04), pharmaceutical review (P = 0.004), and the antibiotic advisor being a pharmacist (P = 0.003) as measures associated with lower overall antibiotic consumption. In the multivariable analysis, antibiotic advisor being a pharmacist (P = 0.002) and pharmaceutical review covering all beds (P = 0.03) were significantly, independently associated with lower antibiotic consumption.
"These results highlight that actions initiated by pharmacists have a positive impact and should be supported," the authors of the study conclude.
Jul 16 J Glob Antimicrob Resist abstract