| . | APEKS-cUTI . | APEKS-NP . | CREDIBLE-CR . |
|---|---|---|---|
| . | (N = 450) . | (N = 300) . | (N = 152) . |
| Feature | Site/indication focus | Site/indication focus | Pathogen-focused |
| US Pivotal | Supplemental NDA | Europe Pivotal | |
| Patients | cUTI/AUP | HAP/VAP/HCAP | cUTI, HAP/VAP/HCAP, BSI/sepsis due to CR GNB |
| Design | Randomized 2:1 | Randomized 1:1 | Randomized 2:1 |
| Double blind | Double blind | Open label | |
| Comparator | Imipenem/cilastatin | Meropenem | “Best available therapy” |
| Status | Completed | Ongoing | Ongoing |
| NCT02321800 | NCT03032380 | NCT02714595 |
| . | APEKS-cUTI . | APEKS-NP . | CREDIBLE-CR . |
|---|---|---|---|
| . | (N = 450) . | (N = 300) . | (N = 152) . |
| Feature | Site/indication focus | Site/indication focus | Pathogen-focused |
| US Pivotal | Supplemental NDA | Europe Pivotal | |
| Patients | cUTI/AUP | HAP/VAP/HCAP | cUTI, HAP/VAP/HCAP, BSI/sepsis due to CR GNB |
| Design | Randomized 2:1 | Randomized 1:1 | Randomized 2:1 |
| Double blind | Double blind | Open label | |
| Comparator | Imipenem/cilastatin | Meropenem | “Best available therapy” |
| Status | Completed | Ongoing | Ongoing |
| NCT02321800 | NCT03032380 | NCT02714595 |
Abbreviations: APEKS, Acinetobacter, Pseudomonas, Escherichia coli, Klebsiella, Stenotrophomonas; AUP, acute uncomplicated pyelonephritis; BSI, bloodstream infection; CR, carbapenem-resistant; CREDIBLE-CR, A MultiCenter, RandomizED, Open-label ClInical Study of S-649266 or Best AvailabLE Therapy for the Treatment of Severe Infections Caused by Carbapenem-Resistant Gram-negative Pathogens; cUTI, complicated urinary tract infection; GNB, gram-negative bacteria; HAP, hospital-acquired pneumonia; HCAP, healthcare-associated pneumonia; NP, nosocomial pneumonia; VAP, ventilator-associated pneumonia.
| . | APEKS-cUTI . | APEKS-NP . | CREDIBLE-CR . |
|---|---|---|---|
| . | (N = 450) . | (N = 300) . | (N = 152) . |
| Feature | Site/indication focus | Site/indication focus | Pathogen-focused |
| US Pivotal | Supplemental NDA | Europe Pivotal | |
| Patients | cUTI/AUP | HAP/VAP/HCAP | cUTI, HAP/VAP/HCAP, BSI/sepsis due to CR GNB |
| Design | Randomized 2:1 | Randomized 1:1 | Randomized 2:1 |
| Double blind | Double blind | Open label | |
| Comparator | Imipenem/cilastatin | Meropenem | “Best available therapy” |
| Status | Completed | Ongoing | Ongoing |
| NCT02321800 | NCT03032380 | NCT02714595 |
| . | APEKS-cUTI . | APEKS-NP . | CREDIBLE-CR . |
|---|---|---|---|
| . | (N = 450) . | (N = 300) . | (N = 152) . |
| Feature | Site/indication focus | Site/indication focus | Pathogen-focused |
| US Pivotal | Supplemental NDA | Europe Pivotal | |
| Patients | cUTI/AUP | HAP/VAP/HCAP | cUTI, HAP/VAP/HCAP, BSI/sepsis due to CR GNB |
| Design | Randomized 2:1 | Randomized 1:1 | Randomized 2:1 |
| Double blind | Double blind | Open label | |
| Comparator | Imipenem/cilastatin | Meropenem | “Best available therapy” |
| Status | Completed | Ongoing | Ongoing |
| NCT02321800 | NCT03032380 | NCT02714595 |
Abbreviations: APEKS, Acinetobacter, Pseudomonas, Escherichia coli, Klebsiella, Stenotrophomonas; AUP, acute uncomplicated pyelonephritis; BSI, bloodstream infection; CR, carbapenem-resistant; CREDIBLE-CR, A MultiCenter, RandomizED, Open-label ClInical Study of S-649266 or Best AvailabLE Therapy for the Treatment of Severe Infections Caused by Carbapenem-Resistant Gram-negative Pathogens; cUTI, complicated urinary tract infection; GNB, gram-negative bacteria; HAP, hospital-acquired pneumonia; HCAP, healthcare-associated pneumonia; NP, nosocomial pneumonia; VAP, ventilator-associated pneumonia.
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