| . | (TOL/TAZ) ASPECT-cUTI [10] . | (CAZ/AVI) RECAPTURE [11] . | (MER-VAB) TANGO-1 [12] . | Plazomicin EPIC [13, 14] . | Cefiderocol APEKS-cUTI [15] . | IV Fosfomycin ZEUS [16, 17] . |
|---|---|---|---|---|---|---|
| Safety ITT population (randomized and treated) (N) | 1068 | 1020 | 545 | 609 | 448 | 464 |
| mMITT (N) | 800 | 810 | 374 | 388 | 371 | 362 |
| % of Safety Population | 74.9 | 79.4 | 68.6 | 64.2 | 83.0 | 78.0 |
| Patient Population | ||||||
| Female (%) | 74 | 69.8 | 66.0 | 52.8 | 55 | 63.5 |
| Age (mean) | 50.5 | 52.4 | 54.0 | 59.4 | 62 | 49.9 |
| Age ≥65 years (%) | 25 | 31.1 | 37.0 | 49.5 | 55 | 34.5 |
| AP/AUP (%) | 82 | 72/62 | 59 | 41.8 | 27 | 53 |
| Pathogens at Baseline | ||||||
| Escherichia coli (%) | 78.6 | 73.8 | 64.7 | 67.8 | 62.3 | 73.4 |
| Pseudomonas aeruginosa (%) | 2.9 | 4.7 | 3.7 | 0 | 6.2 | 4.7 |
| Pathogens at baseline resistant to comparator drug (%) | 26.5 | 3.0 | 12.0 | 2.6 | 3.2 | 5.1 |
| Comparator study drug and dose | Levofloxacin 750 mg Q24H | Doripenem 500 mg Q8H | PIP/TAZ 4.5 g Q8H | Meropenem 1 g Q8H | IMI/CS 1 g Q8H | PIP/TAZ 4.5 g Q8H |
| Randomization | 1:1 | 1:1 | 1:1 | 1:1 | 2:1 | 1:1 |
| Switch from IV to PO | No | Yes | Yes | Yes | No | No |
| Duration of IV therapy (median) | 6.7 days (both groups) | 7 days (CAZ/AVI) 8 days (doripenem) | 8 days (both groups) | 6 days (both groups) | 9 days (both groups) | ~7 days |
| Noninferiority margin (%) (FDA) | 10% | 10% | 15% | 15% | 15% | 15% |
| . | (TOL/TAZ) ASPECT-cUTI [10] . | (CAZ/AVI) RECAPTURE [11] . | (MER-VAB) TANGO-1 [12] . | Plazomicin EPIC [13, 14] . | Cefiderocol APEKS-cUTI [15] . | IV Fosfomycin ZEUS [16, 17] . |
|---|---|---|---|---|---|---|
| Safety ITT population (randomized and treated) (N) | 1068 | 1020 | 545 | 609 | 448 | 464 |
| mMITT (N) | 800 | 810 | 374 | 388 | 371 | 362 |
| % of Safety Population | 74.9 | 79.4 | 68.6 | 64.2 | 83.0 | 78.0 |
| Patient Population | ||||||
| Female (%) | 74 | 69.8 | 66.0 | 52.8 | 55 | 63.5 |
| Age (mean) | 50.5 | 52.4 | 54.0 | 59.4 | 62 | 49.9 |
| Age ≥65 years (%) | 25 | 31.1 | 37.0 | 49.5 | 55 | 34.5 |
| AP/AUP (%) | 82 | 72/62 | 59 | 41.8 | 27 | 53 |
| Pathogens at Baseline | ||||||
| Escherichia coli (%) | 78.6 | 73.8 | 64.7 | 67.8 | 62.3 | 73.4 |
| Pseudomonas aeruginosa (%) | 2.9 | 4.7 | 3.7 | 0 | 6.2 | 4.7 |
| Pathogens at baseline resistant to comparator drug (%) | 26.5 | 3.0 | 12.0 | 2.6 | 3.2 | 5.1 |
| Comparator study drug and dose | Levofloxacin 750 mg Q24H | Doripenem 500 mg Q8H | PIP/TAZ 4.5 g Q8H | Meropenem 1 g Q8H | IMI/CS 1 g Q8H | PIP/TAZ 4.5 g Q8H |
| Randomization | 1:1 | 1:1 | 1:1 | 1:1 | 2:1 | 1:1 |
| Switch from IV to PO | No | Yes | Yes | Yes | No | No |
| Duration of IV therapy (median) | 6.7 days (both groups) | 7 days (CAZ/AVI) 8 days (doripenem) | 8 days (both groups) | 6 days (both groups) | 9 days (both groups) | ~7 days |
| Noninferiority margin (%) (FDA) | 10% | 10% | 15% | 15% | 15% | 15% |
Abbreviations: AP, acute pyelonephritis; AUP, acute uncomplicated pyelonephritis; CAZ/AVI, ceftazidime/avibactam; cUTI, complicated urinary tract infection; FDA, US Food and Drug Administration; IMI/CS, imipenem/cilastatin; ITT, intent-to-treat; IV, intravenous; MER/VAB, meropenem/vaborbactam; mMITT, microbiologic modified intent-to-treat; NA, not applicable; PIP/TAZ, piperacillin/tazobactam; TOL/TAZ, ceftolozane/tazobactam.
| . | (TOL/TAZ) ASPECT-cUTI [10] . | (CAZ/AVI) RECAPTURE [11] . | (MER-VAB) TANGO-1 [12] . | Plazomicin EPIC [13, 14] . | Cefiderocol APEKS-cUTI [15] . | IV Fosfomycin ZEUS [16, 17] . |
|---|---|---|---|---|---|---|
| Safety ITT population (randomized and treated) (N) | 1068 | 1020 | 545 | 609 | 448 | 464 |
| mMITT (N) | 800 | 810 | 374 | 388 | 371 | 362 |
| % of Safety Population | 74.9 | 79.4 | 68.6 | 64.2 | 83.0 | 78.0 |
| Patient Population | ||||||
| Female (%) | 74 | 69.8 | 66.0 | 52.8 | 55 | 63.5 |
| Age (mean) | 50.5 | 52.4 | 54.0 | 59.4 | 62 | 49.9 |
| Age ≥65 years (%) | 25 | 31.1 | 37.0 | 49.5 | 55 | 34.5 |
| AP/AUP (%) | 82 | 72/62 | 59 | 41.8 | 27 | 53 |
| Pathogens at Baseline | ||||||
| Escherichia coli (%) | 78.6 | 73.8 | 64.7 | 67.8 | 62.3 | 73.4 |
| Pseudomonas aeruginosa (%) | 2.9 | 4.7 | 3.7 | 0 | 6.2 | 4.7 |
| Pathogens at baseline resistant to comparator drug (%) | 26.5 | 3.0 | 12.0 | 2.6 | 3.2 | 5.1 |
| Comparator study drug and dose | Levofloxacin 750 mg Q24H | Doripenem 500 mg Q8H | PIP/TAZ 4.5 g Q8H | Meropenem 1 g Q8H | IMI/CS 1 g Q8H | PIP/TAZ 4.5 g Q8H |
| Randomization | 1:1 | 1:1 | 1:1 | 1:1 | 2:1 | 1:1 |
| Switch from IV to PO | No | Yes | Yes | Yes | No | No |
| Duration of IV therapy (median) | 6.7 days (both groups) | 7 days (CAZ/AVI) 8 days (doripenem) | 8 days (both groups) | 6 days (both groups) | 9 days (both groups) | ~7 days |
| Noninferiority margin (%) (FDA) | 10% | 10% | 15% | 15% | 15% | 15% |
| . | (TOL/TAZ) ASPECT-cUTI [10] . | (CAZ/AVI) RECAPTURE [11] . | (MER-VAB) TANGO-1 [12] . | Plazomicin EPIC [13, 14] . | Cefiderocol APEKS-cUTI [15] . | IV Fosfomycin ZEUS [16, 17] . |
|---|---|---|---|---|---|---|
| Safety ITT population (randomized and treated) (N) | 1068 | 1020 | 545 | 609 | 448 | 464 |
| mMITT (N) | 800 | 810 | 374 | 388 | 371 | 362 |
| % of Safety Population | 74.9 | 79.4 | 68.6 | 64.2 | 83.0 | 78.0 |
| Patient Population | ||||||
| Female (%) | 74 | 69.8 | 66.0 | 52.8 | 55 | 63.5 |
| Age (mean) | 50.5 | 52.4 | 54.0 | 59.4 | 62 | 49.9 |
| Age ≥65 years (%) | 25 | 31.1 | 37.0 | 49.5 | 55 | 34.5 |
| AP/AUP (%) | 82 | 72/62 | 59 | 41.8 | 27 | 53 |
| Pathogens at Baseline | ||||||
| Escherichia coli (%) | 78.6 | 73.8 | 64.7 | 67.8 | 62.3 | 73.4 |
| Pseudomonas aeruginosa (%) | 2.9 | 4.7 | 3.7 | 0 | 6.2 | 4.7 |
| Pathogens at baseline resistant to comparator drug (%) | 26.5 | 3.0 | 12.0 | 2.6 | 3.2 | 5.1 |
| Comparator study drug and dose | Levofloxacin 750 mg Q24H | Doripenem 500 mg Q8H | PIP/TAZ 4.5 g Q8H | Meropenem 1 g Q8H | IMI/CS 1 g Q8H | PIP/TAZ 4.5 g Q8H |
| Randomization | 1:1 | 1:1 | 1:1 | 1:1 | 2:1 | 1:1 |
| Switch from IV to PO | No | Yes | Yes | Yes | No | No |
| Duration of IV therapy (median) | 6.7 days (both groups) | 7 days (CAZ/AVI) 8 days (doripenem) | 8 days (both groups) | 6 days (both groups) | 9 days (both groups) | ~7 days |
| Noninferiority margin (%) (FDA) | 10% | 10% | 15% | 15% | 15% | 15% |
Abbreviations: AP, acute pyelonephritis; AUP, acute uncomplicated pyelonephritis; CAZ/AVI, ceftazidime/avibactam; cUTI, complicated urinary tract infection; FDA, US Food and Drug Administration; IMI/CS, imipenem/cilastatin; ITT, intent-to-treat; IV, intravenous; MER/VAB, meropenem/vaborbactam; mMITT, microbiologic modified intent-to-treat; NA, not applicable; PIP/TAZ, piperacillin/tazobactam; TOL/TAZ, ceftolozane/tazobactam.
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