|Sulbactam||Beta-lactam antibacterial, beta-lactamase inhibitor|
Sulbactam/durlobactam, sold under the brand name Xacduro, is a co-packaged medication used to treat bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus complex. It is given by injection into a vein over 3 hours. The other primary treatment for this condition is colistin.
Common side effects include liver problems, low red blood cells, diarrhea, and low potassium. Other side effects may include allergic reactions and Clostridioides difficile-associated diarrhea. It contains sulbactam, a beta-lactam antibacterial and beta-lactamase inhibitor; and durlobactam, a beta-lactamase inhibitor.
Sulbactam/durlobactam was approved for medical use in the United States in 2023. It was not currently available commercially as of August 2023, but was expected to become available in later 2023 in the United States.
Sulbactam/durlobactam is indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
The typical dose is 1 gram sulbactam and 1 gram durlobactam four times per day.
The efficacy of sulbactam/durlobactam was established in a multicenter, active-controlled, open-label (investigator-unblinded, assessor-blinded), non-inferiority clinical trial in 177 hospitalized adults with pneumonia caused by carbapenem-resistant A. baumannii. Participants received either sulbactam/durlobactam or colistin (a comparator antibiotic) for up to 14 days. Both treatment arms also received an additional antibiotic, imipenem/cilastatin, as background therapy for potential hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia pathogens other than Acinetobacter baumannii-calcoaceticus complex. The primary measure of efficacy was mortality from all causes within 28 days of treatment in participants with a confirmed infection with carbapenem-resistant A. baumannii. Of those who received sulbactam/durlobactam, 19% (12 of 63 participants) died, compared to 32% (20 of 62 participants) who received colistin; this demonstrated that sulbactam/durlobactam was noninferior to colistin.
- "Xacduro- sulbactam and durlobactam kit". DailyMed. 2 June 2023. Archived from the original on 18 August 2023. Retrieved 25 June 2023.
- Research, Center for Drug Evaluation and (24 May 2023). "FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria". FDA. Archived from the original on 7 July 2023. Retrieved 15 August 2023.
- "ID Update". Sanford Guide Web Edition. Archived from the original on 30 June 2023. Retrieved 15 August 2023.
- "FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria". U.S. Food and Drug Administration (Press release). 24 May 2023. Retrieved 24 May 2023. This article incorporates text from this source, which is in the public domain.