Efficacy
The first and only treatment of its kind
A landmark trial
for HABP/VABP infections
Evaluating the efficacy and safety of XACDURO versus colistin in patients with infections caused by Acinetobacter
ATTACK is a Phase 3, multinational, randomized, controlled, noninferiority trial conducted to evaluate the efficacy and safety of XACDURO versus colistin, both in combination with imipenem/cilastatin as background therapy, for patients with serious infections due to ABC, including CRABC strains with a Part A randomized cohort of hospitalized adults with documented ABC complex infections.1
ABC=Acinetobacter baumannii-calcoaceticus complex; ATTACK=Acinetobacter Treatment Trial Against Colistin; CRABC=carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex.
A diagram that explains the XACDURO ATTACK study design. On the left, there is a light gray box that states who was included in Part A of the study. It says Part A included patients with documented Acinetobacter baumannii-colcoaceticus complex infections, including hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, ventilated pneumonia, or bloodstream infections. To the right of that, a blue, diamond shape says “1 to 1” referring to the equal number of patients in both the treatment arms. Two arrows point from the blue diamond to an orange box (the XACDURO treatment arm) and a dark gray box (the Colistin treatment arm). Inside the orange box, it says that XACDURO was dosed as 1 gram of sulbactam and 1 gram of durlobactam, plus 1 gram of imipenem and 1 gram of cilastatin, every six hours. Inside the dark gray box, it says Colistin was dosed at 2.5 milligrams per kilogram every 12 hours, plus 1 gram of imipenem and 1 gram of cilastatin, every six hours. A blue arrow points from both the orange and gray boxes to a light blue box. Inside the light blue box, it says that the test of cure was 7 days, plus or minus 2 days, after the last dose. An arrow points from this light blue box to another light blue box that says late follow-up was at 7 days, plus or minus 2 days after the test of cure. Survival was assessed at Day 28.
XACDURO dosing was adjusted for renal function. Colistin dosing was adjusted to ideal body weight and renal function. A single colistin loading dose of 2.5 to 5 mg/kg given intravenously over 3 to 6 minutes (or according to standard of care) was administered on Day 1 for patients who had not received prior colistin therapy.
BSI=bloodstream infection; IMI=imipenem/cilastatin; qxh=every x hours; TOC=test of cure; VP=ventilated pneumonia.
Primary efficacy endpoint:
28-day all-cause mortality in patients with laboratory-confirmed CRABC (microbiologically modified ITT population).1
Prespecified secondary efficacy endpoints1:
- 28-day all-cause mortality in the ITT, microbiologically modified ITT, and CRABC (microbiologically evaluable) populations.
- 14-day all-cause mortality in the CRABC microbiologically modified ITT and microbiologically modified ITT.
- Clinical cure and microbiological favorable assessment at the end of therapy, TOC (7 ± 2 days after end of therapy), and late follow-up (14 ± 2 days after end of therapy) visits in all population.
CRABC= carbapenem-resistant Acinetobacter baumannii-calcoaceticus; ITT=intent to treat; TOC=test of cure.
Meaningfully lowered all‑cause mortality1
A bar chart that shows the rates of all-cause mortality in percentage in XACDURO clinical trials accessed at Day 28. The chart header says “XACDURO meaningfully lowered all-cause mortality.” There are two horizontal bars, one orange bar representing XACDURO and one dark gray bar representing Colistin. The orange bar reads 19%, with an n of 63. The dark gray bar reads 32.3% with an n of 62. There is a callout to the right of the chart that says “reduced patient mortality and improved survival.”
Day 28 All-Cause Mortality (%)
Mortality rate treatment
difference, % (95% CI)-13.2 (-30.0 to 3.5)
Significantly greater clinical cure rates versus colistin1
A bar chart that shows the clinical cure rates at the test of cure in percentage in XACDURO clinical trials. The chart header says “XACDURO achieved significantly greater clinical cure rates versus Colistin.” There are two horizontal bars, one orange bar representing XACDURO and one dark gray bar representing Colistin. The orange bar reads 62%, with an n of 39. The dark gray bar reads 40% with an n of 25. There is a callout to the right of the chart that says “62% cure rate at test of cure.”
Clinical Cure at Test of Cure (%)
When treating HABP/VABP caused by Acinetobacter, act fast with XACDURO
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References:
1. Kaye KS, Shorr AF, Wunderink RG, et al. Efficacy and safety of sulbactam-durlobactam versus colistin for the treatmentof patients with serious infections caused by Acinetobacter baumannii-calcoaceticus complex: a multicentre, randomised, active-controlled, phase 3, non-inferiority clinical trial (ATTACK). Lancet Infect Dis. Published online May 11, 2023. doi:10.1016/S1473‑3099(23)00184‑6