Sulbactam and durlobactam

(Xacduro®)

Sulbactam and durlobactam

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 1 g of sulbactam and 0.5 g of durlobactam)
Drug ClassBeta lactamase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex

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Summary
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  • This summary is based on the review of one randomized controlled trial. [1]
  • In the study, sulbactam-durlobactam demonstrated a lower 28-day all-cause mortality rate (19%) compared to colistin (32%), with a treatment difference of -13.2% (95% confidence interval (CI) -30.0 to 3.5), meeting the criteria for non-inferiority.
  • The study involved adult patients aged 18 years or older with hospital-acquired or ventilator-associated bacterial pneumonia, ventilated pneumonia, or bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (ABC) isolates.
  • Sulbactam-durlobactam was administered in combination with imipenem-cilastatin and showed consistent non-inferiority in various infection types.
  • The incidence of nephrotoxicity was significantly lower in the sulbactam-durlobactam group (13%) compared to the colistin group (38%) (p<0.001).
  • Serious adverse events occurred in 40% of patients treated with sulbactam-durlobactam compared to 49% in the colistin group, and drug discontinuation due to adverse events was lower with sulbactam-durlobactam (11%) compared to colistin (16%).
  • The study population consisted of adults aged 18 years or older with serious infections, including hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, ventilated pneumonia, or bloodstream infections caused by carbapenem-resistant ABC. No significant differences in efficacy or safety were reported across these subgroups.