Sulbactam/durlobactam

Sulbactam/durlobactam
Combination of
SulbactamBeta-lactam antibacterial, beta-lactamase inhibitor
DurlobactamBeta-lactamase inhibitor
Names
Trade namesXacduro
Clinical data
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Routes of
use		Intravenous
Legal
License data
Legal status

Sulbactam/durlobactam, sold under the brand name Xacduro, is a co-packaged medication used to treat bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus complex.[1] It is given by injection into a vein over 3 hours.[1] The other primary treatment for this condition is colistin.[2]

Common side effects include liver problems, low red blood cells, diarrhea, and low potassium.[1] Other side effects may include allergic reactions and Clostridioides difficile-associated diarrhea.[1] It contains sulbactam, a beta-lactam antibacterial and beta-lactamase inhibitor; and durlobactam, a beta-lactamase inhibitor.[1]

Sulbactam/durlobactam was approved for medical use in the United States in 2023.[1] It was not currently available commercially as of August 2023, but was expected to become available in later 2023 in the United States.[3]

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][4]

Dosage

The typical dose is 1 gram sulbactam and 1 gram durlobactam four times per day.[1]

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.[4] Participants received either sulbactam/durlobactam or colistin (a comparator antibiotic) for up to 14 days.[4] 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.[4] 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.[4] 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.[4]

References

  1. 1 2 3 4 5 6 7 8 9 "Xacduro- sulbactam and durlobactam kit". DailyMed. 2 June 2023. Archived from the original on 18 August 2023. Retrieved 25 June 2023.
  2. ↑ 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.
  3. ↑ "ID Update". Sanford Guide Web Edition. Archived from the original on 30 June 2023. Retrieved 15 August 2023.
  4. 1 2 3 4 5 6 "FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria". U.S. Food and Drug Administration (Press release). 24 May 2023. Archived from the original on 7 July 2023. Retrieved 24 May 2023. Public Domain This article incorporates text from this source, which is in the public domain.
Identifiers:
  • 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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