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Study shows that new combination of active ingredients is more effective against complicated urinary tract infections
An international study led by a Rutgers scientist comparing new and older treatments for complicated urinary tract infections has found that a new combination of drugs is more effective, particularly against stubborn, drug-resistant infections. Describing the results in the Journal of the American Medical Association (JAMA), researchers in the Phase 3 ALLIUM clinical trial showed that a combination of the drugs cefepime and enmetazobactam was more effective in treating both complicated urinary tract infections and acute pyelonephritis (AP). a bacterial infection that causes kidney inflammation, as a standard treatment that combines piperacillin and tazobactam. Urinary tract infections are considered complicated when they are associated with risk factors – including...
Study shows that new combination of active ingredients is more effective against complicated urinary tract infections
An international study led by a Rutgers scientist comparing new and older treatments for complicated urinary tract infections has found that a new combination of drugs is more effective, particularly against stubborn, drug-resistant infections.
Describing the results in the Journal of the American Medical Association (JAMA), researchers in the Phase 3 ALLIUM clinical trial showed that a combination of the drugs cefepime and enmetazobactam was more effective in treating both complicated urinary tract infections and acute pyelonephritis (AP). a bacterial infection that causes kidney inflammation, as a standard treatment that combines piperacillin and tazobactam. Urinary tract infections are considered complicated when they are associated with risk factors – including fever, sepsis, urinary tract obstruction or catheters – that increase the risk of antibiotic therapy failure.
“This new antibiotic was superior to standard therapy,” said Keith Kaye, chief of the Division of Allergy, Immunology and Infectious Diseases and professor of medicine at Rutgers Robert Wood Johnson Medical School.
“It represents an exciting treatment option,” said Kaye, the study’s principal investigator and lead author of the paper.
Kaye added that this drug combination also combats an often dangerous category of bacterial diseases caused by pathogens known as extended-spectrum beta-lactamase (ESBL) infections, named for an enzyme the bacteria produce. ESBL-producing bacteria cannot be effectively killed by many antibiotics commonly used to treat infections, such as penicillins and cephalosporins.
We are looking for antibiotics that work against resistant bacteria such as ESBLs, and we have found this new combination to be highly effective.”
Keith Kaye, Professor of Medicine, Rutgers Robert Wood Johnson Medical School
The study was conducted from September 2018 to November 2019 at 90 locations in Europe, North and Central America, South America and South Africa. More than 1,000 patients took part in the study. About 79 percent of patients who received the new combination of cefepime and enmetazobactam were successfully treated for their disease, compared to 58.9 percent of patients who received the traditional treatment of piperacillin and tazobactam.
Of the 20 percent of patients in the overall group who were in the ESBL infection subgroup, 73 percent of patients who received cefepime and enmetazobactam achieved clinical cure, as opposed to 51 percent of patients receiving standard therapy.
The antibiotic cefepime is a fourth-generation cephalosporin that was approved for use in the 1990s and is available generically. Enmetazobactam, an experimental drug from French biopharmaceutical company Allecra Therapeutics, is a beta-lactamase inhibitor, meaning that it attacks the beta-lactamases, including the types of enzymes produced by ESBL-producing bacteria. The drug combination has been granted Qualified Infectious Disease Product and Fast Track designation by the US Food and Drug Administration (FDA).
Kaye said he expects the company to apply for FDA approval early next year.
According to a report from the US Centers for Disease Control and Prevention (CDC), more than 2.8 million antimicrobial-resistant infections occur in the US each year and more than 35,000 people die from them. In a 2019 study on antibiotic resistance, the CDC called ESBLs a serious threat to human health.
A JAMA editorial by Sonali Advani and Kimberly Claeys, both of Duke University School of Medicine, praised the Rutgers-led study: "Kaye et al's clinical trial presents a new therapeutic option for the treatment of acute or complicated pyelonephritis [urinary tract infection]."
Source:
Reference:
Kaye, KS, et al. (2022) Effect of Cefepime/Enmetazobactam vs. Piperacillin/Tazobactam on Clinical Cure and Microbiological Eradication in Patients With Complicated Urinary Tract Infection or Acute Pyelonephritis A Randomized Clinical Trial. JAMA. doi.org/10.1001/jama.2022.17034.
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