Table 5.
Phase II clinical trials evaluating ceftazidime in combination with avibactam for Gram-negative bacterial infections
| Study | Indication | Design | Regimen | Number of patients | Outcome |
|---|---|---|---|---|---|
| Study regimen | |||||
| Lucasti el al24 | Complicated intra-abdominal infection | Phase II prospective, randomized, double-blind, comparative trial | Ceftazidime 2,000 mg + avibactam 500 mg + metronidazole 500 mg, each IV q8h for 5 to 14 days | Randomized: n=101 CE: n=87 ME: n=68 mMITT: n=85 |
Favorable clinical response at test-of-cure visit: CE: 92.0% (80/87) ME: 91.2% (62/68) mMITT: 82.4% (70/85) |
| Comparator regimen | |||||
| Meropenem 1,000 mg IV q8h for 5 to 14 days | Randomized: n=102 CE: n=90 ME: n=76 mMITT: n=89 |
Favorable clinical response at test-of-cure visit: CE: 94.4% (85/90) ME: 93.4% (71/76) mMITT: 88.8% (79/89) |
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| Study regimen | |||||
| Vazquez et al68 | Complicated urinary tract infection | Phase II prospective, randomized, double-blind, comparative trial | Ceftazidime 500 mg + avibactam 125 mg, each IV q8h for a minimum of 4 days (step-down to oral ciprofloxacin was permitted) | Randomized: n=69 CE: n=28 ME: n=27 mMITT: n=46 |
Favorable microbiological response at test-of-cure visit: ME: 70.4% (19/27) mMITT: 67.4% (31/46) Favorable clinical response at test-of-cure visit: CE: 85.7% (24/28) |
| Comparator regimen | |||||
| Imipenem–cilastatin 500 mg IV q6h for a minimum of 4 days (step-down to oral ciprofloxacin was permitted) | Randomized: n=68 CE: n=36 ME: n=35 mMITT: n=49 |
Favorable microbiological response at test-of-cure visit: ME: 71.4% (25/35) mMITT: 63.3% (31/49) Favorable clinical response at test-of-cure visit: CE: 80.6% (29/36) |
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Abbreviations: CE, clinically evaluable; IV, intravenously; ME, microbiologically evaluable; mMITT, microbiologically modified intent to treat; q6h, every 6 hours; q8h, every 8 hours.