Skip to main content

Table 4 Efficacy outcomes in ASPECT-NP participants who were failing prior antibacterial therapy

From: Outcomes in participants with failure of initial antibacterial therapy for hospital-acquired/ventilator-associated bacterial pneumonia prior to enrollment in the randomized, controlled phase 3 ASPECT-NP trial of ceftolozane/tazobactam versus meropenem

Endpoint

C/T n/N (%)

MEM n/N (%)

% Difference (95% CI)a

28-day all-cause mortality (ITT)b

12/53 (22.6)

18/40 (45.0)

22.4 (3.1 to 40.1)

28-day all-cause mortality (mITT)b

7/39 (17.9)

11/24 (45.8)

27.9 (4.7 to 49.0)

Clinical cure at TOC (ITT)b

26/53 (49.1)

15/40 (37.5)

11.6 (− 8.6 to 30.2)

Clinical cure at TOC (CE)c

21/33 (63.6)

9/20 (45.0)

18.6 (− 8.2 to 42.5)

Microbiologic eradication at TOC (mITT)b,d

26/39 (66.7)

16/24 (66.7)

0.0 (− 22.0 to 23.7)

Microbiologic eradication at TOC (ME)b,d

10/17 (58.8)

4/7 (57.1)

1.7 (− 33.7 to 39.3)

  1. CE Clinically evaluable, C/T Ceftolozane/tazobactam, ITT Intention-to-treat, ME Microbiologically evaluable, MEM Meropenem, mITT Microbiological intention-to-treat, TOC Test of cure, n Number of study participants meeting the criteria for each assessment, N Number of study participants in each subgroup of the respective analysis population
  2. aUnstratified Newcombe CIs; positive differences are in favor of ceftolozane/tazobactam, negative differences are in favor of meropenem
  3. bParticipants with missing/indeterminate data were reported as deceased or as failures, depending on the endpoint
  4. cData reported as observed, i.e., participants with missing/indeterminate responses were excluded from analysis
  5. dPer-participant microbiologic eradication