Table 2.
Clinical trials on complicated intra-abdominal infection.
| 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) |
|---|---|---|---|---|---|---|
| Eravacycline | ||||||
| Solomkin [34] | ESBL 9.3% | 1 mg/kg IV, BD (n = 195, 95.4% underwent surgery). | Meropenem 1 g IV, TD (n = 205, 96.1% underwent surgery). | Clinical cure | 25 to 31 days from start therapy | 90.8% vs. 91.2% In ESBL group: 87.5% vs. 84.6%) |
| Solomkin [35] | ESBL 10.9% | 1 mg/kg IV, BD (n = 270, 81.5% underwent surgery) | Ertapenem 1 g IV, QD. (n = 271, 100% received surgery) | Clinical cure | 25 to 31 days from start therapy | 87.0% vs. 88.8% |
| Ceftazidime/avibactam | ||||||
| Qin [37] | Ceftazidime-nonsusceptible 19.7% | 2 g/500 mg IV, TD + metronidazole 500 mg IV, TD (n = 214) | Meropenem 1 g IV, TD (n = 217) | Clinical cure | 28 to 35 days post randomisation | 93.8% vs. 94.0% |
| Mazuski [38] | Ceftazidime-nonsusceptible 13.5% | 2 g/500 mg IV, TD + metronidazole 500 mg IV, TD (n = 529) | Meropenem 1 g IV, TD (n = 529) | Clinical cure | 28 to 35 days post randomisation | 81.6% vs. 85.1% |
| Ceftolozane/tazobactam | ||||||
| Lucasti [39] | 1 g/500 mg IV, TD + metronidazole 500 mg IV, TD (n = 61) | Meropenem 1 g IV, TD (n = 25) | Clinical cure | 7 to 14 days after last doses | 83.6% vs. 96.0% | |
| Popejoy [24] | ESBL 11.1% | 1 g/500 mg IV, TD + metronidazole 500 mg IV, TD (n = 24) | Meropenem 1 g IV, TD (n = 26) | Clinical cure | 24 to 32 days post therapy | 98.1% vs. 88.5% |
| Miller [40] | Carbapenem-nonsusceptible P. aeruginosa 10.1% | 1 g/500 mg IV, TD + metronidazole 500 mg IV, TD (n = 26) | Meropenem 1 g IV, TD (n = 29) | Clinical cure | 24 to 32 days from start therapy | 100% vs. 93.1% |
| Solomkin [41] | ESBL 7.2% | 1 g/500 mg IV, TD + metronidazole 500 mg IV, TD (n = 389) | Meropenem 1 g IV, TD (n = 417) | Clinical cure | 24 to 32 days from start therapy | 83.0% vs. 87.3% ESBL subgroup: 95.8% vs. 88.5% |
* 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.