Table 2.
Comparison of epidemiologic cutoffs and breakpoints.
| Antibiotic | Bacterial Species | Epidemiologic Cutoff (µg/mL) | Nonclinical PK/PD Cutoff (µg/mL) | Clinical Cutoff (µg/mL) | Overall Proposed Breakpoint (µg/mL) | Do FDA and Applicant Breakpoints Agree? |
|---|---|---|---|---|---|---|
| Ceftolozane-Tazobactam [29] | Enterobacteriaceae | 2 | 4 1 | 4 | 2 | Not available |
| Ceftolozane-Tazobactam [29] | P. aeruginosa | 4 | 4 | 1 2 | 4 | Not available |
| Dalbavancin 3 [21] | S. aureus | 0.06 | 0.12–0.25 | 0.06 | 0.06 or 0.125 | No (FDA lower) |
| Oritavancin 3 [22] | S. aureus | 0.12–0.25 | 0.12 | 0.06 | 0.12 | Yes |
| Ceftazidime-Avibactam [16] | P. aeruginosa | 4–8 | 8 | Not available | 8 | Not available |
| Tedizolid 3 [23] | P. aeruginosa | 0.25–1 | 0.5 | Not available | 0.5 | Yes |
| Delafloxacin [24] | S. aureus | 0.25 | 0.25 | Not available | 0.25 | Not available |
| Delafloxacin [24] | E. coli | 4 | 0.25 | Not available | 0.25 | Yes |
| Delafloxacin [24] | P. aeruginosa | >4 | 0.5 | Not available | 0.5 | Yes |
| Meropenem-Vaborbactam [17] | P. aeruginosa | 8 | 8 | Not available | 8 | Yes |
| Meropenem-Vaborbactam [17] | Enterobacteriaceae | 8 | 8 | Not available | 8 | Yes |
| Omadacycline [25] | Enterobacteriaceae | >4 | 8 | 4 | 8 | Not available |
| Omadacycline [25] | S. aureus | 0.5 | 1 | 0.5 | 1 | Not available |
| Plazomicin [26] | Enterobacteriaceae | 2–4 | 1 | Not available | 1 | Not available |
| Cefiderocol [27] | Enterobacteriaceae | 4 | 4 | Not available | 2 | Not available |
| Cefiderocol [27] | P. aeruginosa | 2 | 4 | Not available | 1 | Not available |
| Imipenem-Relebactam [30] | Enterobacteriaceae | 2 | 4 | 2 | 1 | Yes |
| Imipenem-Relebactam [30] | P. aeruginosa | 0.5 | 4 | 4 | 2 | Yes |
| Lefamulin [28] | S. pneumoniae | 0.25 | 0.5 | Not available | 0.5 | No |
| Lefamulin [28] | S. aureus (MSSA 4) | 0.12 | 0.25 | Not available | 0.25 | No |
1 1 µg/mL (tazobactam co-model), number in table represents cefazolin-only model. 2 Inadequate clinical data at higher MIC. 3 Epidemiologic cutoff not available and therefore approximated by MIC90 from microbiological review. 4 Methicillin-susceptible Staphylococcus aureus.