| Type: | combo |
| Component1: | Sulbactam |
| Class1: | beta-lactam antibacterial, beta-lactamase inhibitor |
| Component2: | Durlobactam |
| Class2: | beta-lactamase inhibitor |
| Tradename: | Xacduro |
| Dailymedid: | Sulbactam and durlobactam |
| Routes Of Administration: | Intravenous |
| Atc Prefix: | None |
| Legal Us: | Rx-only |
| Legal Us Comment: | [1] |
| Kegg: | D12605 |
Sulbactam/durlobactam, sold under the brand name Xacduro, is a co-packaged medication used for the treatment of bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus complex. 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 May 2023.[2]
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 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.
Overall, 2.3% of Acinetobacter baumannii strains are resistant to sulbactam/durlobactam. This percentage increases to 3.4% and 3.7% in the subgroups of carbapenem-resistant and colistin-resistant Acinetobacter, respectively. In Acinetobacter strains producing metallo-beta-lactamases, sulbactam/durlobactam resistance is 100%.[3]
Sulbactam/durlobactam was approved for medical use in the United States in May 2023. The FDA granted the application for sulbactam/durlobactam fast track and priority review designations.[4]