Efficacy
The first and only treatment of its kind1,2
A landmark trial
for HABP/VABP infections2
Evaluating the efficacy and safety of XACDURO versus colistin in patients with infections caused by Acinetobacter2
ATTACK was a pivotal, multicenter, active‑controlled, investigator‑unblinded, independent assessor‑blinded, non‑inferiority, phase 3 trial in a randomized cohort of hospitalized adults (N=181) with documented ABC infection.2
ABC, Acinetobacter baumannii-calcoaceticus complex; ATTACK, Acinetobacter Treatment Trial Against Colistin.
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 that says the test of curve is seven plus or minus 2 days after the end of therapy. A blue arrow points from that box to a second light blue box. Inside the second box it says, late follow-up is fourteen plus or minus 2 days after therapy, and all-cause mortality assessed at day 28.
Both in combination with imipenem-cilastatin as background therapy.
Intravenous administration over 3 hours.
Intravenous administration over 30 minutes.
BSI, bloodstream infection; IMI, imipenem‑cilastatin; qxh, every x hours; TOC, test of cure; VP, ventilated pneumonia.
Primary efficacy endpoint2:
28-day all-cause mortality in patients with laboratory-confirmed CRABC (microbiologically modified ITT population).1
Prespecified secondary efficacy endpoints2:
- 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 populations.
- 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 populations.
CRABC, carbapenem-resistant Acinetobacter baumannii-calcoaceticus; ITT=intent to treat; TOC=test of cure.
XACDURO met criteria for non‑inferiority to colistin for 28‑day all‑cause mortality2,a
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 met criteria for non-inferiority to colistin for 28-day 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.
Day 28 All-Cause Mortality (%)
Treatment difference, % (95% CI)-13.2 (-30.0 to 3.5)
aThe upper limit of the two-sided 95% confidence interval was 3.5, which is less than the prespecified noninferiority margin of +20%, indicating noninferiority of XACDURO to colistin in the ATTACK trial. The two-sided 95% confidence interval was computed using a continuity-corrected z statistic.
Greater clinical cure rates versus colistin2
A bar chart that shows the clinical cure rates at the test of cure in percentage in XACDURO clinical trials. The chart header says "Greater clinical cure 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 63. The dark gray bar reads 40% with an n of 62.
Clinical Cure at Test of Cure (%)
Treatment difference, % (95% CI)22 (2.9 to 40.3)
When treating HABP/VABP caused by Acinetobacter, act fast with XACDURO
Want to know more?
Request to speak with a XACDURO sales representative or receive information.
Treat with Precision.
Choose pathogen-targeted coverage for HABP/VABP caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex with XACDURO.2
References:
1. Data on File. Innoviva Specialty Therapeutics; 2023. 2. 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. 2023;23(9):1072‑1084. doi:10.1016/S1473‑3099(23)00184‑6