The US Food and Drug Administration (FDA) has approved Recarbrio, an antibiotic drug created by pharmaceutical company Merck, to treat different varieties of bacterial pneumonia typically contracted in hospitals.
Recarbrio is a mixture of antibiotic imipenem-cilastatin and the beta-lactamase inhibitor, relebactam, used to increase the efficiency of the active antibiotic. The drug has previously been approved to treat patients with complicated urinary tract infections and intra-abdominal infections who have limited or no other treatment options.
Now, the agency has approved the drug for usage against hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by gram-negative microorganisms in people over 18 years old.
Patients usually contract HABP and VABP types of pneumonia in hospital settings. Symptoms include fever, chills, cough, chest pain, and an increased need for oxygen.
To assess the safety of the drug for HABP/VABP, researchers conducted a randomized, controlled clinical trial involving 535 with either condition. While 266 patients were treated with Recarbrio intravenously, the remaining 269 were treated with piperacillin-tazobactam, another drug with antibacterial properties.
In the end, the researchers found that while 21.3% of those on piperacillin-tazobactam died before Day 28 of the study, the same was true for only 15.9% of patients on Recarbrio. Meanwhile, the clinical response at early follow-up was 61% for those on Recarbrio, whereas just 55.8% for the control drug.
Negative side effects for Recarbrio included anemia, diarrhea, hypokalemia (low potassium levels), and hyponatremia (low sodium levels). Before qualifying for treatment with Recarbrio, patients are urged to share information on previous hypersensitivity reactions to allergens that could hamper treatment.
The FDA also notes that the drug should not be used in patients prone to seizures and other nervous system disorders. As with almost all antibacterial drugs, Recarbrio leads to Clostridioides difficile-associated diarrhea and may range from mild diarrhea to fatal colitis.
Sources: FDA, Yahoo News, Drug Topics
