TABLE 2.
Per-participant microbiological cure at TOC visit by renal function group (mITT population)a
| Microbiological cure or presumed cureb | C/T (n/N [%]) | MEM (n/N [%]) | Between treatment arm difference (% [95% CI])c |
|---|---|---|---|
| Normal renal function (CLCR, ≥80 ml/min) | 125/174 (71.8) | 115/158 (72.8) | –0.9 (–10.5 to 8.7) |
| Mild RI (CLCR, >50 to <80 ml/min) | 46/55 (83.6) | 32/56 (57.1) | 26.5 (9.5 to 41.5) |
| Moderate RI (CLCR, ≥30 to ≤50 ml/min) | 13/22 (59.1) | 13/19 (68.4) | –9.3 (–35.4 to 19.2) |
| Severe RI (CLCR, ≥15 to <30 ml/min) | 9/13 (69.2) | 8/14 (57.1) | 12.1 (–22.3 to 42.6) |
a
CI, confidence interval; CLCR, creatinine clearance; C/T, ceftolozane/tazobactam; MEM, meropenem; mITT, microbiological intention to treat; RI, renal impairment; TOC, test of cure; n, number of participants who experienced microbiological cure; N, number of participants in the treatment group.
b
Participants who had a clinical outcome of cure but did not have follow-up cultures to document eradication were assessed as presumed cures.
c
The 95% CIs are unstratified.