Sulbactam/durlobactam
Combination of
Sulbactambeta-lactam antibacterial, beta-lactamase inhibitor
Durlobactambeta-lactamase inhibitor
Clinical data
Trade namesXacduro
License data
Routes of
administration		Intravenous
ATC code
  • None
Legal status
Legal status
Identifiers
KEGG

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.[1][2] It contains sulbactam, a beta-lactam antibacterial and beta-lactamase inhibitor; and durlobactam, a beta-lactamase inhibitor.[1][2]

Sulbactam/durlobactam was approved for medical use in the United States in May 2023.[1][2]

Medical uses

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.[1][2]

History

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.[2] Participants received either sulbactam/durlobactam or colistin (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 than Acinetobacter 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]

Resistances

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]

Society and culture

Sulbactam/durlobactam was approved for medical use in the United States in May 2023.[1][2] The FDA granted the application for sulbactam/durlobactam fast track and priority review designations.[4]

References

  1. 1 2 3 4 5 6 "Xacduro- sulbactam and durlobactam kit". DailyMed. 2 June 2023. Retrieved 25 June 2023.
  2. 1 2 3 4 5 6 7 8 9 10 "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. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ↑ Principe L, Di Bella S, Conti J, Perilli M, Piccirilli A, Mussini C, et al. (December 2022). "Acinetobacter baumannii Resistance to Sulbactam/Durlobactam: A Systematic Review". Antibiotics. 11 (12): 1793. doi:10.3390/antibiotics11121793. PMC 9774100. PMID 36551450.
  4. ↑ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.
  • Clinical trial number NCT03894046 for "Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex (ATTACK)" at ClinicalTrials.gov


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