Table 3 Efficacy endpoints among all patients with confirmed CRE infections (mCRE-MITT) in TANGO II study [14]

From: Clinical Outcomes of Patient Subgroups in the TANGO II Study

  M-V (n = 32) n (%) BAT (n = 15) n (%) Differencea (95% CI) p value Relative differenceb
Efficacy endpoints
 Clinical cure at EOT 21 (65.6) 5 (33.3) 32.3 (3.3 to 61.3) 0.03 97.0
 Clinical cure at TOC 19 (59.4) 4 (26.7) 32.7 (4.6 to 60.8) 0.02 122.5
 Microbiologic curec at EOT 21 (65.6) 6 (40.0) 25.6 (− 4.1 to 55.4) 0.09 64.0
 Microbiologic curec at TOC 17 (53.1) 5 (33.3) 19.8 (− 9.7 to 49.3) 0.19 59.5
 Day-28 mortality 5 (15.6) 5 (33.3)  − 17.7 (− 44.7 to 9.3) 0.20  − 53.2
Exploratory analysis of risk–benefit profile of M-V compared to BAT
 Day-28 all-cause mortality or nephrotoxicitye 8 (25.0) 6 (40.0)  − 15.0 (− 44.0 to 14.0) 0.31  − 37.5
 Clinical failure or nephrotoxicityf 10 (31.3) 12 (80.0)  − 48.7 (− 74.6 to − 22.9)  < 0.001  − 60.9
 Day-28 all-cause mortality or renal AEsg 6 (18.8) 9 (60.0)  − 41.2 (− 69.5 to − 13.0) 0.004  − 68.7
 Clinical failure or renal AEsh 9 (28.1) 12 (80.0)  − 51.9 (− 77.4 to − 26.3)  < 0.001  − 64.9
  M-V (n = 23) n (%) BAT (n = 15) n (%) Differencea (95% CI) p value Relative differenceb
Sensitivity analysis of clinical cure at TOC and all-cause mortality at day 28 across all infection types (mCRE-MITT) excluding prior antibiotic failured
 Clinical cure at TOC 16 (69.6) 4 (26.7) 42.9 (13.7 to 72.1) 0.004 160.7
 Day-28 all-cause mortality 1 (4.3) 5 (33.3)  − 29.0 (− 54.3 to − 3.7) 0.02  − 87.1
  1. Reused with permission under open access Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) from Wunderink et al. [14]. Used with permission under open access license
  2. AE adverse event, BAT best available therapy, CI confidence interval, cUTI/AP complicated urinary tract infection/acute pyelonephritis, EOT end of treatment, mCRE-MITT microbiologic carbapenem-resistant Enterobacteriaceae modified intent-to-treat, M-V meropenem–vaborbactam, TOC test of cure
  3. aData represent the difference in percentages for meropenem–vaborbactam and BAT (95% CI for that difference)
  4. bData represent (difference in percentage for meropenem–vaborbactam and BAT)/BAT
  5. cComposite of either microbiologic eradication or presumed eradication at respective visit
  6. dPatients assessed as having prior antibiotic failure at randomization (meropenem–vaborbactam, 9; BAT, 0) were excluded from this analysis
  7. eComposite outcome of either day-28 all-cause mortality or a post-baseline increase in serum creatinine ≥ 1.0 mg/dL
  8. fComposite outcome of either clinical failure at test of cure or a post-baseline increase in serum creatinine ≥ 1.0 mg/dL
  9. gComposite outcome of either day-28 all-cause mortality or adverse event of renal failure, renal failure acute, or renal impairment
  10. hComposite outcome of either clinical failure at test of cure or adverse event of renal failure, renal failure acute, or renal impairment