Table 3.
Clinical studies on hospital-acquired or ventilator-associated pneumonia.
| First Author (Ref) | Resistant Microorganisms * | Dose New Antibiotic (n Patient) | Comparator, Dose (n Patient) | Definition Outcome | Timing Assessment of Outcomes | Outcomes (New Antibiotics vs. Comparator) |
|---|---|---|---|---|---|---|
| Plazomicin | ||||||
| McKinnell [20] | CRE 100% | 15 mg/kg IV, QD (n = 18 patients) + meropenem or tigecycline | Colistin 5 mg/kg IV, QD (n = 21) + meropenem or tigecycline | Death from any cause or clinically significant disease-related complications occurred in | At 28 day | 24% vs. 50% |
| Cefiderocol | ||||||
| Wunderink [51] | ESBL 31% CRE 13% |
2 g IV, TID + linezolid 600 mg IV, BD (n = 145) | Meropenem 2 g IV, TID + linezolid 600 mg IV, BD (n = 146) | All-cause mortality | Day 14 | 12.4% vs. 11.6% |
| Ceftazidime/avibactam | ||||||
| Torres [59] | Ceftazidime non-susceptible 28% | 2 g/500 mg IV, TD + (n = 356) | Meropenem 1 g IV, TD (n = 370) | Clinical cure | 21 to 25 days post randomization | 68.8% vs. 73.0% |
| Ceftolozane/tazobactam | ||||||
| Kollef [62] | No information | 2 g/1 g IV, TD (n = 362) | Meropenem 1 g IV, TD (n = 364) | All cause mortality | At 28 day | 24.0% vs. 25.3% |
| Imipenem-cilastatin/relebactam | ||||||
| Titov [63] | No information | 500 mg/250 mg IV, QD (n = 268) |
Piperacillin/tazobactam 4 g/500 mg IV, QD (n = 269) | All cause mortality | At 28 day | 15.9% vs. 21.3% |
* Only data on ESBL or CRE are mentioned; if total data not available, only data from new antibiotics are included. Abbreviations: IV, intravenous; PO, by mouth; BD, twice daily; TID, three times daily; QD, once a day; ESBL: extended-spectrum beta-lactamases, CRE: carbapenem-resistant Enterobacterales.