New York (US): According to an international study comparing recent and traditional therapies for challenging urinary tract infections, a novel medication combination has been found to be more efficient, particularly against chronic, drug-resistant infections.
The Journal of the American Medical Association (JAMA) published research from the ALLIUM Phase 3 clinical trial showing that cefepime and enmetazobactam were superior to the standard treatment regimen of piperacillin and tazobactam in treating complicated urinary tract infections and acute pyelonephritis (AP), a bacterial infection that results in kidney inflammation.
Urinary tract infections are referred to as complex urinary tract infections when they are accompanied by risk factors that increase the likelihood that antibiotic therapy may fail, such as fevers, sepsis, urinary obstruction, or catheters.
"This new antibiotic was superior to the standard-of-care therapy," said Keith Kaye, chief of the Division of Allergy, Immunology and Infectious Diseases and a professor of medicine at Rutgers Robert Wood Johnson Medical School.
"It represents an exciting option for treatment," said Kaye, the principal investigator of the study and lead author of the publication.
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The extended-spectrum beta-lactamase (ESBL) infections are a class of usually serious bacterial diseases brought on by pathogens. They are called after an enzyme the bacteria generate. Antibiotics like penicillins and cephalosporins, which are frequently used to treat infections, are useless against bacteria that produce ESBLs.
"We are looking for antibiotics that are active against resistant bacteria, such as ESBLs, and we found this new combination to be highly effective," Kaye said.
The study took place in 90 locations across Europe, North and Central America, South and Central America, and South Africa from September 2018 to November 2019. Over a thousand participants participated in the trial.
Approximately 79% of patients who received the innovative regimen of cefepime and enmetazobactam had their illness effectively treated, as opposed to 58.9% of patients who received the traditional regimen of piperacillin and tazobactam.
Only 51% of patients getting conventional medication and 73% of those receiving cefepime and enmetazobactam out of the 20% of patients in the entire sample who belonged to the subgroup of those with ESBL infections were clinically cured.
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Cefepime, a generically available fourth-generation cephalosporin antibiotic, was approved for usage in the 1990s. The French biopharmaceutical firm Allecra Therapeutics' beta-lactamase inhibitor enmetazobactam targets beta-lactamases, including the sorts of enzymes generated by ESBL-producing bacteria.
The medicine combination has been accorded Fast Track classification by the U.S. Food and Drug Administration, which classifies it as a Qualified Infectious Disease Product (FDA).
Kaye anticipated that the company would submit an FDA application early next year.
Research from the US Centers for Disease Control and Prevention estimates that more than 2.8 million antimicrobial-resistant illnesses occur in the US annually and result in the deaths of more than 35,000 individuals (CDC). A 2019 study on antibiotic resistance claims that ESBLs represent a significant risk to human health. (ANI)
