Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 1 g of sulbactam and 0.5 g of durlobactam) |
| Drug Class | Beta 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
Latest News
Summary
- 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.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Xacduro (sulbactam and durlobactam) Prescribing Information. | 2023 | Entasis Therapeutics Inc., Waltham, MA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Efficacy and safety of sulbactam-durlobactam versus colistin for the treatment of patients with serious infections caused by Acinetobacter baumannii-calcoaceticus complex: a multicentre, randomised, active-controlled, phase 3, non-inferiority clinical trial (ATTACK) | 207Subjects F: 25% M: 75% | 2023 | The Lancet Infectious Diseases |
Sex Distribution:
F:25%
M:75%
207Subjects
Year:
2023
Source:The Lancet Infectious Diseases