Table 4.
Definitions Of Microbiological Outcome (Response) Parameters
| HAP/VAP/HCAP | BSI/Sepsis | cUTI | |
|---|---|---|---|
| EA, EOT, TOC | |||
| Eradication | Absence of the baseline Gram-negative pathogen from an appropriate clinical specimen. If it is not possible to obtain an appropriate clinical culture and the patient has a successful clinical outcome, the response will be presumed to be eradication. | Absence of the baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the patient has a successful clinical outcome and it is not possible to obtain an appropriate clinical culture, the response will be presumed to be eradication. | A urine culture shows the baseline Gram-negative uropathogen found at entry at ≥105 CFU/mL are reduced to <103 CFU/mL. |
| Persistence | Continued presence of the baseline Gram-negative pathogen from an appropriate clinical specimen. | Continued presence of the baseline Gram-negative pathogen from a blood culture or other primary source. | A urine culture shows that the baseline Gram-negative uropathogen found at entry at ≥105 CFU/mL grows ≥103 CFU/mL. |
| Indeterminate | No culture obtained from an appropriate clinical specimen or additional antibacterial therapy for the treatment of the current infection including missed sampling. | No culture obtained or additional antibacterial therapy for the treatment of the current infection including missed sampling. | No urine culture obtained or additional antibacterial therapy for the treatment of the current infection including missed sampling. |
| FUP | |||
| Sustained eradication | Absence of the baseline Gram-negative pathogen from an appropriate clinical specimen after TOC. If it is not possible to obtain an appropriate clinical culture and the patient has a successful clinical response after TOC, the response will be presumed to be eradication. | Absence of the baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable. In the case of sepsis, if the patient has a successful clinical outcome after TOC and it is not possible to obtain an appropriate clinical culture, the response will be presumed to be sustained eradication. | A culture taken any time after documented eradication at TOC, and a urine culture obtained at FUP shows that the baseline uropathogen found at entry at ≥105 CFU/mL remains <103 CFU/mL. |
| Recurrence | Recurrence of the baseline Gram-negative pathogen from an appropriate clinical specimen taken after TOC, and the TOC culture is negative. | Recurrence of the baseline Gram-negative pathogen from a blood culture or other primary source after TOC, and the TOC culture is negative. | A culture taken any time after documented eradication at TOC, up to and including FUP that grows the baseline uropathogen ≥103 CFU/mL. |
| Indeterminate | No culture obtained from an appropriate clinical specimen or patient received additional antibacterial therapy for the treatment of the current infection including missed sampling. | No culture or patient received additional antibacterial therapy for the treatment of the current infection including missed sampling. | No urine culture or patient received additional antibacterial therapy for the treatment of the current infection including missed sampling. |
Abbreviations: HAP, hospital-acquired pneumonia; VAP, ventilator-associated pneumonia; HCAP, healthcare-associated pneumonia; BSI, bloodstream infection; cUTI, complicated urinary tract infection; EA, early assessment; EOT, end of therapy; TOC, test of cure; CFU, colony-forming unit.