TABLE 3.
Per-pathogen clinical cure at TOC visit by renal function group (mITT population)a
| Baseline pathogen, n/N1 (%) | Normal renal function (CLCR, ≥80 ml/min) |
Mild RI (CLCR, >50 to <80 ml/min) |
Moderate RI (CLCR, ≥30 to ≤50 ml/min) |
Severe RI (CLCR, ≥15 to <30 ml/min) |
||||
|---|---|---|---|---|---|---|---|---|
| C/T (N = 227) | MEM (N = 235) | C/T (N = 82) | MEM (N = 77) | C/T (N = 35) | MEM (N = 26) | C/T (N = 17) | MEM (N = 21) | |
| Gram-negative | 113/170 (66.5) | 97/151 (64.2) | 30/53 (56.6) | 24/56 (42.9) | 7/21 (33.3) | 6/17 (35.3) | 6/12 (50.0) | 8/14 (57.1) |
| Pseudomonas aeruginosa | 25/38 (65.8) | 27/41 (65.9) | 9/16 (56.3) | 11/19 (57.9) | 2/5 (40.0) | 1/2 (50.0) | 0/3 | 0/3 |
| Enterobacterales | 87/127 (68.5) | 73/115 (63.5) | 21/40 (52.5) | 18/41 (43.9) | 5/15 (33.3) | 6/17 (35.3) | 6/10 (60.0) | 6/10 (60.0) |
| Escherichia coli | 23/33 (69.7) | 19/26 (73.1) | 7/14 (50.0) | 4/11 (36.4) | 1/3 (33.3) | 1/2 (50.0) | 1/1 (100.0) | 2/3 (66.7) |
| Klebsiella pneumoniae | 38/53 (71.7) | 42/58 (72.4) | 10/21 (47.6) | 11/22 (50.0) | 1/5 (20.0) | 2/5 (40.0) | 3/6 (50.0) | 3/6 (50.0) |
| ESBL-producing Enterobacterales | 37/57 (64.9) | 31/45 (68.9) | 9/15 (60.0) | 8/17 (47.1) | 1/7 (14.3) | 2/4 (50.0) | 1/4 (25.0) | 4/7 (57.1) |
Cure was defined as eradication or presumed eradication. Eradication was defined as a ≥1-log reduction in bacterial burden from the baseline lower respiratory tract specimen and a per-pathogen count of ≤104 CFU/ml for endotracheal aspiration or sputum specimens, ≤103 CFU/ml for bronchoalveolar lavage fluid specimens, or ≤102 CFU/ml for protected brush specimens. Presumed eradication was defined as the absence of material to culture in a participant deemed a clinical cure. CLCR, creatinine clearance; C/T, ceftolozane/tazobactam; ESBL, extended-spectrum β-lactamase; MEM, meropenem; mITT, microbiological intention-to-treat; n, number of participants who experienced clinical cure; N, number of participants within the subgroup; N1, number of participants in the subgroup with the specified pathogen; RI, renal impairment; TOC, test of cure.