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| Combination of | |
|---|---|
| Sulbactam | beta-lactam antibacterial,beta-lactamase inhibitor |
| Durlobactam | beta-lactamase inhibitor |
| Clinical data | |
| Trade names | Xacduro |
| License data | |
| Routes of administration | Intravenous |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| KEGG | |
Sulbactam/durlobactam, sold under the brand nameXacduro (by Innoviva Specialty Therapeutics), is a co-packaged medication used for the treatment of bacterial pneumonia caused byAcinetobacter baumannii-calcoaceticus complex.[1][2] It containssulbactam, abeta-lactam antibacterial andbeta-lactamase inhibitor; anddurlobactam, a beta-lactamase inhibitor.[1][2]
Sulbactam/durlobactam was approved for medical use in the United States in May 2023.[1][2]
Sulbactam/durlobactam isindicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by susceptible isolates ofAcinetobacter baumannii-calcoaceticus complex.[1][2]
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-resistantA. baumannii.[2] Participants received either sulbactam/durlobactam orcolistin (a comparator antibiotic) for up to 14 days.[2] 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 thanAcinetobacter baumannii-calcoaceticus complex.[2] 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.[2] 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.[2]
Overall, 2.3% ofAcinetobacter baumannii strains are resistant to sulbactam/durlobactam. This percentage increases to 3.4% and 3.7% in the subgroups of carbapenem-resistant and colistin-resistantAcinetobacter, respectively. InAcinetobacter 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.[1][2] The FDA granted the application for sulbactam/durlobactamfast track andpriority review designations.[4]
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