TABLE 11.
Studies evaluating ceftolozane-tazobactam for Enterobacterales infections
| Study ID; main pathogen tested (reference)a | Designb | No. included (p/i)c | Source of infectiond | No. of isolates by type | No. of isolates by susceptibility | Combination treatment? | Outcomes (no. [%])e |
|---|---|---|---|---|---|---|---|
| Huntington 2016; Levor pathogens (148) | Post hoc analysis of RCT (143) (C-T vs Levo) | 212 p, 225 i (mMITT) | 212 UTI, 7 BSI | 186 Enterobacterales, 12 P. aeruginosa, 27 Gram positive | 212 p Levo nonsusceptible, 85 p ESBL | No |
Clinical response TOC: C-T, 90/100 (90.0); comp, 86/112 (76.8) Microbiol response TOC: C-T, 63/100 (63.0); comp, 49/112 (43.8) |
| Popejoy 2017; ESBL-producing Enterobacterales (322) | Post hoc analysis of 2 RCTs (142, 143) | 150 p, 159 i |
UTI: 54 C-T, 46 Levo IAI: 24 C-T, 26 Mero |
UTI: E coli: 36 C-T, 36 Levo; K. pneumoniae: 10 C-T, 7 Levo IAI: E. coli: 14 C-T, 20 Levo; K. pneumoniae; 8 C-T, 4 Levo |
All ESBL | No |
Clinical cure TOC: C-T, 76/78 (97.4); Levo, 38/46 (82.6); Mero, 23/26 (88.5) Microbiol cure TOC: C-T, 62/78 (79.5); Levo/Mero, 45/72 (62.5) |
| Arakawa 2019; ESBL-producing Enterobacterales (149) | Nonrandomized single group | Overall 115 p: evaluable, 90 p 94 i | 90 UTI, 24 BSI | 93 Enterobacterales, 1 P. aeruginosa, | 13/94 ESBL | No |
(For all patients) Mortality: 0/114 Clinical response TOC: 86/89 (96.6) Microbiol response TOC: 71/88 (80.7) (For ESBL) Mortality: 0/13 Microbiol response TOC: 5/13 (38.5) |
| Mikamo 2019; ESBL producing Enterobacterales (150) | Nonrandomized single group | Overall 100 p, 130 i | 130 i IAI | 58 Enterobacterales, 9 P. aeruginosa, 27 Gram positive, 36 anaerobes | 5/130 ESBL | No |
(For all patients) Mortality: 1/100 (1) Clinical response TOC: 81/88 (92.0) Microbiol response TOC: 55/61 (90.2) (For ESBL) Mortality: 0/5 Clinical response TOC: 5/5 (100) Microbiol response TOC: 5/5 (100) |
a
Levor, levofloxacin resistant; ESBL, extended spectrum β-lactamase.
b
RCT, randomized controlled trial; C-T, ceftolozane-tazobactam.
c
p, patients; i, isolates; mMITT, microbiologically modified intention to treat.
d
UTI, urinary tract infection; BSI, bloodstream infection; IAI, intra-abdominal infection.
e
Microbiol, microbiological; TOC, test of cure.